Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors
Sponsor
Five Prime Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02318329
Collaborator
(none)
79
26
3
55.9
3
0.1
Study Details
Study Description
Brief Summary
This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients.
Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.
Study Design
Study Type:
Interventional
Actual Enrollment
:
79 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors
Study Start Date
:
Nov 1, 2014
Actual Primary Completion Date
:
Feb 28, 2019
Actual Study Completion Date
:
Jun 30, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1A: FPA144 Dose Escalation Solid Tumors Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg) |
Drug: FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Other Names:
|
| Experimental: Part 1B: FPA144 Dose Escalation Gastric Cancer Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer |
Drug: FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Other Names:
|
| Experimental: Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression |
Drug: FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). [4 weeks on average]
Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)
- Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only) [16 weeks on average]
Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)
Secondary Outcome Measures
- Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration [16 weeks on average]
Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration,
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [16 weeks on average]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Duration of Response Per RECIST 1.1 (Part 2 Only) [16 weeks on average]
Duration of complete or partial response with 95% confidence intervals in gastric cancer population.
- Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve [16 weeks on average]
Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration,
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Life expectancy of at least 3 months
-
ECOG performance status of 0 to 1
• In sexually-active patients, willingness to use 2 effective methods of contraception
-
Adequate hematological and organ function, confirmed by lab values
-
Tumor tissue must be available for prospective determination of FGFR2b overexpression
-
Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment
-
Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract
-
Measurable disease as defined by RECIST version 1.1
Exclusion Criteria:
-
Untreated or symptomatic central nervous system (CNS) metastases
-
Impaired cardiac function or clinically significant cardiac disease
-
Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144
-
Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1
-
Retinal disease or a history of retinal disease or detachment
-
Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea
-
Major surgical procedures are not allowed ≤28 days prior to FPA144 administration
-
Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study
-
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
-
Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate
-
History of prior malignancy except:
-
- Curatively treated non-melanoma skin cancer or
-
- Solid tumor treated curatively more than 5 years previously without evidence of recurrence or
-
- History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
-
Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
| 2 | Ronald Reagan UCLA Medical Center | Los Angeles | California | United States | 90095 |
| 3 | UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay | San Francisco | California | United States | 74158 |
| 4 | Innovative Cancer Research Institute | Whittier | California | United States | 90603 |
| 5 | The University of Chicago Medical Center | Chicago | Illinois | United States | 60637 |
| 6 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 7 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 8 | Weill Cornell Medical Center | New York | New York | United States | 10065 |
| 9 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 10 | Sarah Cannon Research Institute, LLC | Nashville | Tennessee | United States | 37203 |
| 11 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 12 | The University of Texas M.D. Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
| 13 | South Texas Accelerated Research Therapeutics, LLC | San Antonio | Texas | United States | 78229 |
| 14 | Chonbuk National University Hospital | Jeonju | Jeollabuk-do | Korea, Republic of | 561-712 |
| 15 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | 463-707 | |
| 16 | Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 | |
| 17 | Severance Hospital, Yonsei University | Seoul | Korea, Republic of | 120-752 | |
| 18 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 | |
| 19 | Gangnam Severance Hospital | Seoul | Korea, Republic of | 135-720 | |
| 20 | Korea University Anam Hospital | Seoul | Korea, Republic of | 136-705 | |
| 21 | Seoul St. Mary's Hospital | Seoul | Korea, Republic of | 137-701 | |
| 22 | SMG-SNU Boramae Medical Center | Seoul | Korea, Republic of | 156-707 | |
| 23 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
| 24 | National Cheng Kung University Hospital | Tainan | Taiwan | 704 | |
| 25 | National Taiwan University Hospital | Taipei | Taiwan | 100 | |
| 26 | Taipei Veterans General Hospital | Taipei | Taiwan | 11217 |
Sponsors and Collaborators
- Five Prime Therapeutics, Inc.
Investigators
- Study Director: Medical Lead, Five Prime Therapeutics, Inc.
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02318329
Other Study ID Numbers:
- FPA144-001
First Posted:
Dec 17, 2014
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Five Prime Therapeutics, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 1mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 1.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort. | A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 3.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort. | A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 6.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort. | A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 10 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort. | A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 15 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles. | Part 1B will be a 3 + 3 design and enroll patients with gastric cancer. Participants may be gastric cancer patients whose tumors will be tested retrospectively, or those who are known to be FGFR2 gene-amplified or FGFR2b protein-overexpressed. In a staggered fashion with Part 1A dose escalation, patients in Part 1B will be enrolled one dose level below the current highest dose level cohort being studied in Part 1A. Dose: 6.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort. | Part 1B will be a 3 + 3 design and enroll patients with gastric cancer. Participants may be gastric cancer patients whose tumors will be tested retrospectively, or those who are known to be FGFR2 gene-amplified or FGFR2b protein-overexpressed. In a staggered fashion with Part 1A dose escalation, patients in Part 1B will be enrolled one dose level below the current highest dose level cohort being studied in Part 1A. Dose: 10 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort. | Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B. |
| Period Title: Overall Study | ||||||||||
| STARTED | 3 | 4 | 3 | 3 | 3 | 3 | 1 | 1 | 6 | 52 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 3 | 4 | 3 | 3 | 3 | 3 | 1 | 1 | 6 | 52 |
Baseline Characteristics
| Arm/Group Title | Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg | Part 1B: FPA144 Dose Escalation Gastric 6 mg/kg | Part 1B: FPA144 Dose Escalation Gastric 10 mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.. | 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 15 mg/kg IV every 2 weeks in 28 day cycles. | Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B. | Total of all reporting groups |
| Overall Participants | 3 | 4 | 3 | 3 | 3 | 3 | 1 | 1 | 6 | 52 | 79 |
| Age, Customized (years) [Median (Full Range) ] | |||||||||||
| Median (Full Range) [years] |
74
|
64.5
|
63
|
62
|
64
|
59
|
54
|
39
|
52
|
57
|
59
|
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
1
33.3%
|
2
50%
|
0
0%
|
1
33.3%
|
2
66.7%
|
2
66.7%
|
1
100%
|
0
0%
|
3
50%
|
21
40.4%
|
33
41.8%
|
| Male |
2
66.7%
|
2
50%
|
3
100%
|
2
66.7%
|
1
33.3%
|
1
33.3%
|
0
0%
|
1
100%
|
3
50%
|
31
59.6%
|
46
58.2%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.9%
|
1
1.3%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
100%
|
1
100%
|
5
83.3%
|
39
75%
|
46
58.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.9%
|
1
1.3%
|
| White |
3
100%
|
4
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
0
0%
|
0
0%
|
1
16.7%
|
11
21.2%
|
31
39.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||||||||
| South Korea |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
100%
|
1
100%
|
5
83.3%
|
33
63.5%
|
40
50.6%
|
| United States |
3
100%
|
4
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
0
0%
|
0
0%
|
1
16.7%
|
14
26.9%
|
34
43%
|
| Taiwan |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
5
9.6%
|
5
6.3%
|
Outcome Measures
| Title | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). |
|---|---|
| Description | Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs) |
| Time Frame | 4 weeks on average |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who received FPA144 |
| Arm/Group Title | Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles. |
| Measure Participants | 3 | 4 | 3 | 3 | 3 | 3 | 1 | 1 | 6 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only) |
|---|---|
| Description | Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only) |
| Time Frame | 16 weeks on average |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who received FPA144 |
| Arm/Group Title | Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors |
|---|---|---|---|---|
| Arm/Group Description | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles. | Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B. |
| Measure Participants | 1 | 1 | 6 | 52 |
| Count of Participants [Participants] |
1
33.3%
|
1
25%
|
6
200%
|
48
1600%
|
| Title | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration |
|---|---|
| Description | Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration, |
| Time Frame | 16 weeks on average |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients in the PK Full Analysis Population who have sufficient PK samples for the calculation of at least one PK parameter on at least one Study Day. Dose normalized PK parameters were reported so that patients at 0.3 mg/kg were excluded from mean value for part 1a because it is in the non-linear dose range. |
| Arm/Group Title | Phase 1a Dose Escalation 0.3 mg/kg | Phase 1a Dose Escalation 1 mg/kg | Phase 1a Dose Escalation 3 mg/kg | Phase 1a Dose Escalation 6 mg/kg | Phase 1a Dose Escalation 10 mg/kg | Phase 1a Dose Escalation 15 mg/kg | Phase 1b Dose Escalation in Gastric Cancer 3 mg/kg | Phase 1b Dose Escalation in Gastric Cancer 6 mg/kg | Phase 1b Dose Escalation in Gastric Cancer 10 mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles. | Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B. |
| Measure Participants | 0 | 4 | 3 | 3 | 3 | 3 | 1 | 1 | 5 | 49 |
| Mean (Standard Deviation) [ug/ml] |
0.2483
(0.08763)
|
0.3117
(0.06536)
|
0.2873
(0.02793)
|
0.4097
(0.03208)
|
0.3847
(0.14931)
|
0.4900
(0)
|
0.232
(0)
|
0.2990
(0.06690)
|
0.3145
(0.06981)
|
| Title | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
|---|---|
| Description | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Time Frame | 16 weeks on average |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients with various levels of FGFR2b overexpression in tumor samples treated with bemarituzumab who had baseline and post baseline scans performed. |
| Arm/Group Title | Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 6mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 10mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles. | Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B. |
| Measure Participants | 3 | 4 | 1 | 3 | 3 | 3 | 1 | 1 | 6 | 49 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
100%
|
1
16.7%
|
4
7.7%
|
| Title | Duration of Response Per RECIST 1.1 (Part 2 Only) |
|---|---|
| Description | Duration of complete or partial response with 95% confidence intervals in gastric cancer population. |
| Time Frame | 16 weeks on average |
Outcome Measure Data
| Analysis Population Description |
|---|
| Gastric cancer patients with various levels of FGFR2b overexpression treated with FPA144 who had an objective response. |
| Arm/Group Title | Part 1/2: FPA144 Dose Expansion Gastric or Other Solid Tumors |
|---|---|
| Arm/Group Description | Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B. |
| Measure Participants | 6 |
| Median (95% Confidence Interval) [Weeks] |
14.1
|
| Title | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve |
|---|---|
| Description | Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration, |
| Time Frame | 16 weeks on average |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients in the PK Full Analysis Population who have sufficient PK samples for the calculation of at least one PK parameter on at least one Study Day. Dose normalized PK parameters were reported so that patients at 0.3 mg/kg were excluded from mean value for part 1a because it is in the non-linear dose range. |
| Arm/Group Title | Phase 1a Dose Escalation 0.3 mg/kg | Phase 1a Dose Escalation 1 mg/kg | Phase 1a Dose Escalation 3 mg/kg | Phase 1a Dose Escalation 6 mg/kg | Phase 1a Dose Escalation 10 mg/kg | Phase 1a Dose Escalation 15 mg/kg | Phase 1b Dose Escalation in Gastric Cancer 3 mg/kg | Phase 1b Dose Escalation in Gastric Cancer 6 mg/kg | Phase 1b Dose Escalation in Gastric Cancer 10 mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles. | Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B. |
| Measure Participants | 0 | 4 | 3 | 3 | 3 | 3 | 1 | 1 | 3 | 49 |
| Mean (Standard Deviation) [ug*day/ml] |
1.288
(0.5159)
|
1.547
(0.2902)
|
1.427
(0.2367)
|
1.863
(0.4119)
|
1.697
(0.1464)
|
2.69
(0)
|
1.59
(0)
|
1.648
(0.4055)
|
1.867
(0.4495)
|
Adverse Events
| Time Frame | Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered. | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||
| Arm/Group Title | Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | ||||||||||
| Arm/Group Description | 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with 15mg/kg FPA144 IV every 2 weeks in 28 day cycles. | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles | 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles | Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B. | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 5/52 (9.6%) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/3 (33.3%) | 0/4 (0%) | 2/3 (66.7%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 2/6 (33.3%) | 17/52 (32.7%) | ||||||||||
| Congenital, familial and genetic disorders | ||||||||||||||||||||
| Corneal Dystrophy | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| Limbal stem cell deficiency | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/52 (0%) | ||||||||||
| Ulcerative Keratitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Gastrointestinal Hemorrhage | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Abdominal Pain, Upper | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/52 (0%) | ||||||||||
| Nausea | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Ileus | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Hemorrhoids | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Duodenal Perforation | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Ascites | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Large intestinal Obstruction | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Dysphagia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Hematemesis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Intestinal Obstruction | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Intestinal Perforation | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Vomiting | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| General disorders | ||||||||||||||||||||
| Pain | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Pyrexia | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Device Malfunction | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/52 (0%) | ||||||||||
| Peripheral Oedema | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Liver Abscess | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Septic Shock | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Arthritis bacterial | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Psoas Abscess | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Sepsis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Bacteremia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Device Related Infection | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Escherichia Bacteraemia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Infusion Reaction | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||
| Decreased Appetite | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Dehydration | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Hyponatremia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Malnutrition | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||
| Squamous Cell Carcinoma | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Tumor Hemorrhage | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Renal and urinary disorders | ||||||||||||||||||||
| Acute Kidney Injury | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Azotemia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| urinary tract obstruction | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Pneumonitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg | Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg | Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg | Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 4/4 (100%) | 3/3 (100%) | 3/3 (100%) | 2/3 (66.7%) | 3/3 (100%) | 1/1 (100%) | 1/1 (100%) | 6/6 (100%) | 48/52 (92.3%) | ||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||
| Anemia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 14/52 (26.9%) | ||||||||||
| Cardiac disorders | ||||||||||||||||||||
| Atrial Fibrillation | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Tachycardia | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||
| Ear Pain | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Eustachian Tube Obstruction | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| Dry Eye | 2/3 (66.7%) | 1/4 (25%) | 2/3 (66.7%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 7/52 (13.5%) | ||||||||||
| Eye Disorder | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Eye Pruritus | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/52 (0%) | ||||||||||
| Keratitis | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Lacrimation Increased | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Limbal Stem Cell Deficiency | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/52 (0%) | ||||||||||
| Metamorphosia | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Abdominal Discomfort | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 1/52 (1.9%) | ||||||||||
| Abdominal Distention | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 4/52 (7.7%) | ||||||||||
| Abdominal Pain Upper | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 2/6 (33.3%) | 3/52 (5.8%) | ||||||||||
| Ascites | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 4/52 (7.7%) | ||||||||||
| Constipation | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 7/52 (13.5%) | ||||||||||
| Diarrhoea | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 8/52 (15.4%) | ||||||||||
| Dry Mouth | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Dyspepsia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 2/6 (33.3%) | 3/52 (5.8%) | ||||||||||
| Dysphagia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Gastrointestinal Sounds Abnormal | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/52 (0%) | ||||||||||
| Gastrooesophageal Reflux Disease | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Melaena | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/52 (0%) | ||||||||||
| Nausea | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 1/1 (100%) | 1/6 (16.7%) | 14/52 (26.9%) | ||||||||||
| Oesophageal Hemorrhage | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/52 (0%) | ||||||||||
| Oesophagitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Vomiting | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 2/3 (66.7%) | 1/1 (100%) | 0/1 (0%) | 2/6 (33.3%) | 7/52 (13.5%) | ||||||||||
| Abdominal Pain | 1/3 (33.3%) | 2/4 (50%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 0/1 (0%) | 1/1 (100%) | 3/6 (50%) | 14/52 (26.9%) | ||||||||||
| General disorders | ||||||||||||||||||||
| Asthenia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 2/6 (33.3%) | 1/52 (1.9%) | ||||||||||
| Chest Pain | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 2/52 (3.8%) | ||||||||||
| Chills | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/52 (0%) | ||||||||||
| Early Satiety | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Facial Pain | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Fatigue | 1/3 (33.3%) | 0/4 (0%) | 2/3 (66.7%) | 1/3 (33.3%) | 1/3 (33.3%) | 1/3 (33.3%) | 1/1 (100%) | 0/1 (0%) | 2/6 (33.3%) | 12/52 (23.1%) | ||||||||||
| Oedema Peripheral | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 3/6 (50%) | 7/52 (13.5%) | ||||||||||
| Pyrexia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 7/52 (13.5%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Anorectal Infection | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Bronchitis | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Ear Infection | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Fungal Skin Infection | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Oral Herpes | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Pharyngitis | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Pneumonia | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 2/52 (3.8%) | ||||||||||
| Sinusitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Skin Infection | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Upper Respiratory Infection | 2/3 (66.7%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Fall | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Infusion Related Reaction | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 2/6 (33.3%) | 1/52 (1.9%) | ||||||||||
| Muscle Strain | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Wound Dehiscence | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Investigations | ||||||||||||||||||||
| Alanine Aminotransferase Increase | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 4/52 (7.7%) | ||||||||||
| Aspartate Aminotransferase Increased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 2/6 (33.3%) | 4/52 (7.7%) | ||||||||||
| Blood Alkaline Phosphatase Increased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Blood Creatinine Increased | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Lymphocyte Count Decreased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Neutrophil Count Decreased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 2/6 (33.3%) | 0/52 (0%) | ||||||||||
| Platelet Count Decreased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 1/52 (1.9%) | ||||||||||
| Weight Decreased | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 5/52 (9.6%) | ||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||
| Decreased Appetite | 1/3 (33.3%) | 2/4 (50%) | 0/3 (0%) | 2/3 (66.7%) | 0/3 (0%) | 0/3 (0%) | 1/1 (100%) | 0/1 (0%) | 1/6 (16.7%) | 16/52 (30.8%) | ||||||||||
| Dehydration | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 1/52 (1.9%) | ||||||||||
| Hypercalcemia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 2/52 (3.8%) | ||||||||||
| Hyperkalemia | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Hypoalbuminemia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 2/6 (33.3%) | 6/52 (11.5%) | ||||||||||
| Hypokalemia | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Hypomagnesemia | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 1/52 (1.9%) | ||||||||||
| Hyponatremia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Arthralgia | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Back Pain | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 1/1 (100%) | 0/6 (0%) | 6/52 (11.5%) | ||||||||||
| Bone Pain | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Muscle Spasms | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Muscular Weakness | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Musculoskeletal Pain | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 2/52 (3.8%) | ||||||||||
| Neck Pain | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Pain in Extremity | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 4/52 (7.7%) | ||||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||
| Basal Cell Carcinoma | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Cancer Pain | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Tumor Pain | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 1/3 (33.3%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Dizziness | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/1 (100%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Dysgeusia | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Headache | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Lethargy | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Nervous System Disorder | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Neuropathy Peripheral | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/1 (100%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Paresthesia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Psychiatric disorders | ||||||||||||||||||||
| Anxiety | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Depression | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 1/52 (1.9%) | ||||||||||
| Renal and urinary disorders | ||||||||||||||||||||
| Chromaturia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Cystitis Non-infective | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Urinary Retention | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||
| Dyspareunia | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Vulvovaginal Dryness | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Cough | 0/3 (0%) | 0/4 (0%) | 2/3 (66.7%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 3/6 (50%) | 1/52 (1.9%) | ||||||||||
| Dyspnea | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 4/52 (7.7%) | ||||||||||
| Nasal Congestion | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Nasal Ulcer | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Pleural Effusion | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 2/6 (33.3%) | 2/52 (3.8%) | ||||||||||
| Productive Cough | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 1/52 (1.9%) | ||||||||||
| Rhinalgia | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Rhinorrhea | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 1/6 (16.7%) | 1/52 (1.9%) | ||||||||||
| Sinus Congestion | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Upper Airway Cough Syndrome | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Wheezing | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Actinic Keratosis | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Alopecia | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Dry Skin | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 1/1 (100%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Erythema | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Hair Colour Changes | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Hyperhidrosis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Nail Disorder | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/1 (100%) | 0/1 (0%) | 1/6 (16.7%) | 2/52 (3.8%) | ||||||||||
| Onychomadesis | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Pruritus | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/1 (100%) | 1/1 (100%) | 1/6 (16.7%) | 3/52 (5.8%) | ||||||||||
| Rash | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 1/1 (100%) | 0/6 (0%) | 3/52 (5.8%) | ||||||||||
| Rash maculo-papular | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Surgical and medical procedures | ||||||||||||||||||||
| Sinus Operation | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
| Vascular disorders | ||||||||||||||||||||
| Hypertension | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 2/52 (3.8%) | ||||||||||
| Hypotension | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/1 (0%) | 0/1 (0%) | 0/6 (0%) | 0/52 (0%) | ||||||||||
Limitations/Caveats
Inclusion of patients with refractory gastric cancer with short duration of drug exposure may have limited our ability to accurately evaluate the incidence of off-target effects adverse events in the study population, in particular corneal toxicity.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Medical Lead |
|---|---|
| Organization | Five Prime Therapeutics |
| Phone | 415-365-5600 |
| FPA144@fiveprime.com |
Responsible Party:
Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02318329
Other Study ID Numbers:
- FPA144-001
First Posted:
Dec 17, 2014
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021