FPA008-002: Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
Study Details
Study Description
Brief Summary
This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
A Phase 1/2 study was an open-label, dose escalation and dose expansion study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of cabiralizumab, a CSF1-R monoclonal antibody, inpatients with unresectable diffuse tenosynovial giant cell tumors (TGCT).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Phase 1 FPA008 Dose Escalation IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. RD will be the maximum tolerated dose or lower dose that provide adequate PK exposure and biologic activity with tolerability. |
Biological: FPA008
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
Other Names:
|
Experimental: Phase 2 FPA008 Dose Expansion IV infusion; once MTD and/or RD has been determined in Phase 1, expansion cohorts of approximately 30 patients (each cohort) with PVNS or dt-TGCT will be enrolled to characterize clinical activity and safety profile of the RD. Treatment is planned to continue for up to 24 weeks or 56 weeks. |
Biological: FPA008
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 [52 weeks]
Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1
- The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) [52 weeks]
Number of confirmed objective responses (ORR) as assessed by the investigator per RECIST 1.1 (Phase 2)
Secondary Outcome Measures
- PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) [52 weeks]
Area under serum concentration-time curve (AUC) for cabiralizumab as a PK parameter
- Maximum Serum Concentration (Cmax). [52 weeks]
Composite PK parameters of cabiralizumab: Maximum observed serum concentration
- Minimum Serum Concentration (Cmin). [52 weeks]
Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin).
- Pharmacokinetic Clearance (CL). [52 weeks]
Composite PK parameters of cabiralizumab: clearance (CL)
- The Incidence of AEs. [52 weeks]
treatment-emergent adverse events (TEAEs) by incidence for the Safety Population. Patients with at lease 1 TEAE.
- The Incidence of Clinical Laboratory Abnormalities. [52 weeks]
The number of patients with a clinical laboratory that is outside the normal range at some time point during the study
- The Incidence of ECG Abnormalities. [52 weeks]
The number of patients who had a change in their ECG that were clinically significant
- Duration of Response Per RECIST 1.1 in Phase 2 [52 weeks]
The length of response per RECIST 1.1 from the time of first response to progression or going off study in Phase 2
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially resectable tumor that would result in unacceptable functional loss or morbidity as determined by a qualified surgeon or multi-disciplinary tumor board (must be documented in the CRF during screening)
-
Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI
-
ECOG performance status <1
Exclusion Criteria:
-
Prior therapy with an anti-CSF1R antibody
-
Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression on prior kinase inhibitor)
-
Liver function tests (including ALT, AST, and total bilirubin), outside of the range of local laboratory normal at Screening
-
Inadequate organ or bone marrow function
-
History of congestive heart failure or myocardial infarction <1 year prior to first study dose administration
-
Significant abnormalities on ECG at Screening
-
Contraindications to MRI and use of intravenous gadolinium-based contrast agents
-
Creatine Kinase ≥ 1.5x the upper limit of normal
-
Positive test for latent TB at Screening (Quantiferon test)
-
Active known or suspected autoimmune disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
2 | Sarcoma Oncology Research Center LLC | Santa Monica | California | United States | 90403 |
3 | Stanford Medicine | Stanford | California | United States | 94301-5821 |
4 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
5 | The University of Texas, MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
6 | Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest | Bordeaux | France | 33076 | |
7 | Centre Léon Bérard | Lyon | France | 69008 | |
8 | Seoul National University Hospital | Seoul | Jongno-gu | Korea, Republic of | 110-744 |
9 | Leiden University Medical Center | Leiden | Netherlands | 2333 ZA | |
10 | Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie | Warsaw | Poland | 02-781 | |
11 | University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom | B15 2TH | |
12 | Oxford University Hospital NHS Trust | Oxford | United Kingdom | OX3 7LE |
Sponsors and Collaborators
- Five Prime Therapeutics, Inc.
Investigators
- Study Director: Medical Lead, Five Prime Therapeutics, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.- FPA008-002
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B |
---|---|---|---|---|---|
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. |
Period Title: Overall Study | |||||
STARTED | 3 | 3 | 3 | 33 | 24 |
COMPLETED | 3 | 2 | 3 | 18 | 8 |
NOT COMPLETED | 0 | 1 | 0 | 15 | 16 |
Baseline Characteristics
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B | Total |
---|---|---|---|---|---|---|
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. | Total of all reporting groups |
Overall Participants | 3 | 3 | 3 | 33 | 24 | 66 |
Age (Count of Participants) | ||||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
3
100%
|
2
66.7%
|
3
100%
|
32
97%
|
22
91.7%
|
62
93.9%
|
>=65 years |
0
0%
|
1
33.3%
|
0
0%
|
1
3%
|
2
8.3%
|
4
6.1%
|
Age (years) [Mean (Standard Deviation) ] | ||||||
Mean (Standard Deviation) [years] |
37.7
(11.24)
|
40.7
(23.07)
|
41.7
(7.51)
|
38
(12.77)
|
44.1
(15.32)
|
40.8
(14.03)
|
Sex: Female, Male (Count of Participants) | ||||||
Female |
3
100%
|
3
100%
|
1
33.3%
|
23
69.7%
|
10
41.7%
|
40
60.6%
|
Male |
0
0%
|
0
0%
|
2
66.7%
|
10
30.3%
|
14
58.3%
|
26
39.4%
|
Race/Ethnicity, Customized (Count of Participants) | ||||||
American Indian/alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
8.3%
|
2
3%
|
Native Hawaiian/Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
White |
3
100%
|
2
66.7%
|
2
66.7%
|
9
27.3%
|
9
37.5%
|
25
37.9%
|
Asian |
0
0%
|
1
33.3%
|
0
0%
|
5
15.2%
|
1
4.2%
|
7
10.6%
|
Other |
0
0%
|
0
0%
|
0
0%
|
19
57.6%
|
8
33.3%
|
27
40.9%
|
Unknown |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
4
16.7%
|
5
7.6%
|
Outcome Measures
Title | The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 |
---|---|
Description | Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1 |
Time Frame | 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg |
---|---|---|---|
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks |
Measure Participants | 3 | 3 | 3 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) |
---|---|
Description | Number of confirmed objective responses (ORR) as assessed by the investigator per RECIST 1.1 (Phase 2) |
Time Frame | 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B |
---|---|---|
Arm/Group Description | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. |
Measure Participants | 32 | 24 |
Count of Participants [Participants] |
8
266.7%
|
8
266.7%
|
Title | PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) |
---|---|
Description | Area under serum concentration-time curve (AUC) for cabiralizumab as a PK parameter |
Time Frame | 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B |
---|---|---|---|---|---|
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. |
Measure Participants | 3 | 2 | 1 | 2 | 3 |
Geometric Mean (Geometric Coefficient of Variation) [ug x day/mL] |
102
(10.2)
|
283
(26.3)
|
593
(31.3)
|
660
(17.7)
|
593
(12.6)
|
Title | Maximum Serum Concentration (Cmax). |
---|---|
Description | Composite PK parameters of cabiralizumab: Maximum observed serum concentration |
Time Frame | 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B |
---|---|---|---|---|---|
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. |
Measure Participants | 3 | 3 | 3 | 30 | 24 |
Geometric Mean (Geometric Coefficient of Variation) [ug/mL] |
22.5
(14.3)
|
52.1
(22)
|
91.2
(15)
|
91.8
(24.8)
|
87
(12.6)
|
Title | Minimum Serum Concentration (Cmin). |
---|---|
Description | Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin). |
Time Frame | 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B |
---|---|---|---|---|---|
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. |
Measure Participants | 3 | 3 | 3 | 30 | 24 |
Geometric Mean (Geometric Coefficient of Variation) [ug/mL] |
2.18
(117)
|
7.26
(41.8)
|
21.2
(59.2)
|
23.9
(38.3)
|
22.6
(28.2)
|
Title | Pharmacokinetic Clearance (CL). |
---|---|
Description | Composite PK parameters of cabiralizumab: clearance (CL) |
Time Frame | 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B |
---|---|---|---|---|---|
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. |
Measure Participants | 3 | 2 | 1 | 2 | 3 |
Geometric Mean (Geometric Coefficient of Variation) [L/d] |
.663
(16.6)
|
.416
(24.5)
|
.694
(0)
|
.307
(44.9)
|
.525
(8.42)
|
Title | The Incidence of AEs. |
---|---|
Description | treatment-emergent adverse events (TEAEs) by incidence for the Safety Population. Patients with at lease 1 TEAE. |
Time Frame | 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B |
---|---|---|---|---|---|
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. |
Measure Participants | 3 | 3 | 3 | 33 | 24 |
Count of Participants [Participants] |
3
100%
|
3
100%
|
3
100%
|
33
100%
|
24
100%
|
Title | The Incidence of Clinical Laboratory Abnormalities. |
---|---|
Description | The number of patients with a clinical laboratory that is outside the normal range at some time point during the study |
Time Frame | 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B |
---|---|---|---|---|---|
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. |
Measure Participants | 3 | 2 | 3 | 33 | 24 |
Number [participants] |
3
100%
|
2
66.7%
|
3
100%
|
33
100%
|
24
100%
|
Title | The Incidence of ECG Abnormalities. |
---|---|
Description | The number of patients who had a change in their ECG that were clinically significant |
Time Frame | 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
The changes in the ECG parameters were not clinically significant in any dosing cohort in the study |
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B |
---|---|---|---|---|---|
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. |
Measure Participants | 3 | 3 | 3 | 33 | 24 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Duration of Response Per RECIST 1.1 in Phase 2 |
---|---|
Description | The length of response per RECIST 1.1 from the time of first response to progression or going off study in Phase 2 |
Time Frame | 52 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B |
---|---|---|
Arm/Group Description | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. |
Measure Participants | 8 | 8 |
Median (95% Confidence Interval) [months] |
4.4
|
NA
|
Adverse Events
Time Frame | Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated. | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||||
Arm/Group Title | Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B | |||||
Arm/Group Description | Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks | Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. | Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. | |||||
All Cause Mortality |
||||||||||
Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/32 (3.1%) | 0/24 (0%) | |||||
Serious Adverse Events |
||||||||||
Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) | 8/33 (24.2%) | 6/24 (25%) | |||||
Cardiac disorders | ||||||||||
Myocarditis | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Congenital, familial and genetic disorders | ||||||||||
Twin reversed arterial perfusion sequence malformation | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Gastrointestinal disorders | ||||||||||
Abdominal pain | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Abdominal pain lower | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Colitis | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Diverticulum | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Abdominal pain upper | /3 (NaN) | /3 (NaN) | 1/3 (33.3%) | 0/33 (0%) | 0/24 (0%) | |||||
General disorders | ||||||||||
Pyrexia | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Influenza like illness | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Systemic inflammatory response syndrome | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Hepatobiliary disorders | ||||||||||
Cholelithiasis | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Drug-induced liver injury | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Infections and infestations | ||||||||||
Lobar pneumonia | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Viral infection | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Streptococcal sepsis | /3 (NaN) | /3 (NaN) | 1/3 (33.3%) | 0/33 (0%) | 0/24 (0%) | |||||
Intervertebral discitis | /3 (NaN) | /3 (NaN) | 1/3 (33.3%) | 0/33 (0%) | 0/24 (0%) | |||||
Endocarditis | /3 (NaN) | /3 (NaN) | 1/3 (33.3%) | 0/33 (0%) | 0/24 (0%) | |||||
Musculoskeletal and connective tissue disorders | ||||||||||
Systemic lupus erythematosus | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
Sarcoma | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Nervous system disorders | ||||||||||
Cerebellar infarction | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Migraine | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Reproductive system and breast disorders | ||||||||||
Menorrhagia | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Skin and subcutaneous tissue disorders | ||||||||||
Dermatitis exfoliative | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Skin atrophy | /3 (NaN) | /3 (NaN) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Vascular disorders | ||||||||||
Hypertension | /3 (NaN) | /3 (NaN) | 1/3 (33.3%) | 0/33 (0%) | 0/24 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
Phase 1 FPA008 Dose Escalation 1mg/kg | Phase 1 FPA008 Dose Escalation 2mg/kg | Phase 1 FPA008 Dose Escalation 4mg/kg | Phase 2 FPA008 Dose Expansion Cohort 2A | Phase 2 FPA008 Dose Expansion Cohort 2B | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | 33/33 (100%) | 24/24 (100%) | |||||
Blood and lymphatic system disorders | ||||||||||
Anaemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/33 (9.1%) | 0/24 (0%) | |||||
Lymphadenopathy | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Neutropenia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Cardiac disorders | ||||||||||
Palpitations | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Sinus bradycardia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Sinus tachycardia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Ear and labyrinth disorders | ||||||||||
Hearing impaired | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Tinnitus | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Endocrine disorders | ||||||||||
Cushingoid | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Eye disorders | ||||||||||
Abnormal sensation in eye | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 0/24 (0%) | |||||
Conjunctival hyperaemia | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Conjunctival oedema | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/33 (0%) | 0/24 (0%) | |||||
Dry eye | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 2/33 (6.1%) | 1/24 (4.2%) | |||||
Eye pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Eyelid oedema | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 6/33 (18.2%) | 7/24 (29.2%) | |||||
Eyelid rash | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Eyelid skin dryness | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Lacrimation increased | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 4/33 (12.1%) | 5/24 (20.8%) | |||||
Periorbital oedema | 2/3 (66.7%) | 2/3 (66.7%) | 2/3 (66.7%) | 20/33 (60.6%) | 13/24 (54.2%) | |||||
Photophobia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Scleritis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Vision blurred | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 3/33 (9.1%) | 5/24 (20.8%) | |||||
Visual acuity reduced | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Gastrointestinal disorders | ||||||||||
Abdominal pain upper | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 2/24 (8.3%) | |||||
Colitis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Constipation | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/33 (3%) | 0/24 (0%) | |||||
Diarrhoea | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 3/33 (9.1%) | 1/24 (4.2%) | |||||
Diarrhoea haemorrhagic | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Food poisoning | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Haemorrhoids | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Lip swelling | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Nausea | 2/3 (66.7%) | 0/3 (0%) | 1/3 (33.3%) | 5/33 (15.2%) | 3/24 (12.5%) | |||||
Oral pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Vomiting | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 4/33 (12.1%) | 3/24 (12.5%) | |||||
Abdominal discomfort | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 0/24 (0%) | |||||
Abdominal pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/33 (9.1%) | 0/24 (0%) | |||||
Cheilitis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Flatulence | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Lip oedema | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 0/24 (0%) | |||||
Salivary hypersecretion | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/33 (0%) | 0/24 (0%) | |||||
Stomatitis | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/33 (0%) | 0/24 (0%) | |||||
General disorders | ||||||||||
Asthenia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 7/33 (21.2%) | 5/24 (20.8%) | |||||
Chest pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Chills | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Face oedema | 0/3 (0%) | 1/3 (33.3%) | 2/3 (66.7%) | 22/33 (66.7%) | 12/24 (50%) | |||||
Fatigue | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) | 11/33 (33.3%) | 8/24 (33.3%) | |||||
Gait disturbance | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Generalised oedema | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Local swelling | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Non-cardiac chest pain | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Oedema | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 2/24 (8.3%) | |||||
Oedema peripheral | 2/3 (66.7%) | 1/3 (33.3%) | 2/3 (66.7%) | 19/33 (57.6%) | 8/24 (33.3%) | |||||
Pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Peripheral swelling | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/33 (3%) | 3/24 (12.5%) | |||||
Pyrexia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 5/33 (15.2%) | 1/24 (4.2%) | |||||
Sensation of foreign body | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Swelling | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Localised oedema | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Hepatobiliary disorders | ||||||||||
Biliary colic | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Cholelithiasis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Hepatic pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Hepatocellular injury | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Infections and infestations | ||||||||||
Abscess | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Acarodermatitis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Cellulitis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Conjunctivitis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Ear infection | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Gastroenteritis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Hordeolum | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Influenza | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Ophthalmic herpes zoster | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Oral candidiasis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 1/24 (4.2%) | |||||
Otitis externa | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Pneumonia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Respiratory tract infection | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Urinary tract infection | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 1/24 (4.2%) | |||||
Viral infection | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Vulvovaginal candidiasis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Injury, poisoning and procedural complications | ||||||||||
Contusion | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Joint dislocation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Joint injury | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Post procedural inflammation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Investigations | ||||||||||
Activated partial thromboplastin time prolonged | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Alanine aminotransferase increased | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) | 6/33 (18.2%) | 0/24 (0%) | |||||
Aspartate aminotransferase increased | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) | 10/33 (30.3%) | 3/24 (12.5%) | |||||
Blood alkaline phosphatase increased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Blood bilirubin increased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Blood cholesterol increased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 4/33 (12.1%) | 0/24 (0%) | |||||
Blood creatine phosphokinase increased | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) | 21/33 (63.6%) | 16/24 (66.7%) | |||||
Blood lactate dehydrogenase increased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 4/33 (12.1%) | 3/24 (12.5%) | |||||
Blood pressure increased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
C-reactive protein increased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Troponin I increased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Weight increased | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 3/33 (9.1%) | 2/24 (8.3%) | |||||
Metabolism and nutrition disorders | ||||||||||
Decreased appetite | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Hypercalcaemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Hypercholesterolaemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 7/33 (21.2%) | 1/24 (4.2%) | |||||
Hyperglycaemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Hypertriglyceridaemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Hypoglycaemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Hypokalaemia | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/33 (3%) | 0/24 (0%) | |||||
Hyponatraemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Hypophosphataemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Increased appetite | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Musculoskeletal and connective tissue disorders | ||||||||||
Arthralgia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 10/33 (30.3%) | 3/24 (12.5%) | |||||
Arthritis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 1/24 (4.2%) | |||||
Back pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Flank pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Joint effusion | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Joint range of motion decreased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Joint swelling | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 2/24 (8.3%) | |||||
Knee deformity | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Lupus-like syndrome | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Mobility decreased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Muscle spasms | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 1/24 (4.2%) | |||||
Musculoskeletal discomfort | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Musculoskeletal pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Musculoskeletal stiffness | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Myalgia | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 2/33 (6.1%) | 3/24 (12.5%) | |||||
Neck pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Pain in extremity | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Pain in jaw | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Rhabdomyolysis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Spinal pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Synovitis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
Bladder cancer | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/33 (0%) | 0/24 (0%) | |||||
Haemangioma of bone | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Tumour pain | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/33 (0%) | 0/24 (0%) | |||||
Nervous system disorders | ||||||||||
Burning sensation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Carpal tunnel syndrome | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Cervicobrachial syndrome | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Dizziness | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 3/24 (12.5%) | |||||
Dysgeusia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Headache | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 7/33 (21.2%) | 3/24 (12.5%) | |||||
Hyperaesthesia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Hypoaesthesia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 1/24 (4.2%) | |||||
Migraine | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Neuralgia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Neuropathy peripheral | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/33 (9.1%) | 0/24 (0%) | |||||
Nystagmus | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Paraesthesia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 5/33 (15.2%) | 2/24 (8.3%) | |||||
Poor quality sleep | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Sciatica | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 1/24 (4.2%) | |||||
Tremor | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Psychiatric disorders | ||||||||||
Affective disorder | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Anxiety | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 2/24 (8.3%) | |||||
Insomnia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 2/24 (8.3%) | |||||
Renal and urinary disorders | ||||||||||
Bladder spasm | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Dysuria | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Haematuria | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/33 (9.1%) | 1/24 (4.2%) | |||||
Reproductive system and breast disorders | ||||||||||
Dysfunctional uterine bleeding | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Menometrorrhagia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Menorrhagia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Menstruation irregular | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Pelvic pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 2/24 (8.3%) | |||||
Respiratory, thoracic and mediastinal disorders | ||||||||||
Cough | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/33 (9.1%) | 1/24 (4.2%) | |||||
Dysphonia | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Dyspnoea | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 4/33 (12.1%) | 2/24 (8.3%) | |||||
Dyspnoea exertional | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Epistaxis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Laryngeal oedema | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Nasal congestion | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Pleural effusion | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Productive cough | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Rhinitis allergic | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Rhinorrhoea | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 0/24 (0%) | |||||
Sleep apnoea syndrome | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Wheezing | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Skin and subcutaneous tissue disorders | ||||||||||
Acne | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Cold sweat | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Dermatitis | 2/3 (66.7%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 0/24 (0%) | |||||
Dermatitis acneiform | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/33 (9.1%) | 0/24 (0%) | |||||
Drug eruption | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Dry skin | 0/3 (0%) | 1/3 (33.3%) | 2/3 (66.7%) | 2/33 (6.1%) | 4/24 (16.7%) | |||||
Eczema | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Erythema | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 5/33 (15.2%) | 1/24 (4.2%) | |||||
Generalised erythema | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Hirsutism | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Hyperhidrosis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Macule | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Mechanical urticaria | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Night sweats | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Pain of skin | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Petechiae | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 1/24 (4.2%) | |||||
Photosensitivity reaction | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Pruritus | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 17/33 (51.5%) | 13/24 (54.2%) | |||||
Pruritus generalised | 1/3 (33.3%) | 1/3 (33.3%) | 1/3 (33.3%) | 5/33 (15.2%) | 1/24 (4.2%) | |||||
Psoriasis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Rash | 1/3 (33.3%) | 1/3 (33.3%) | 2/3 (66.7%) | 11/33 (33.3%) | 10/24 (41.7%) | |||||
Rash erythematous | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/33 (9.1%) | 1/24 (4.2%) | |||||
Rash generalised | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 3/24 (12.5%) | |||||
Rash macular | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 1/24 (4.2%) | |||||
Rash maculo-papular | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 8/33 (24.2%) | 1/24 (4.2%) | |||||
Rash papular | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Rash pruritic | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 5/33 (15.2%) | 1/24 (4.2%) | |||||
Skin atrophy | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 3/24 (12.5%) | |||||
Skin discolouration | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Skin disorder | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) | 4/33 (12.1%) | 5/24 (20.8%) | |||||
Skin exfoliation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/33 (0%) | 2/24 (8.3%) | |||||
Skin hyperpigmentation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Skin lesion | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 1/24 (4.2%) | |||||
Skin striae | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Swelling face | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Urticaria | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 3/33 (9.1%) | 0/24 (0%) | |||||
Xeroderma | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/33 (3%) | 0/24 (0%) | |||||
Vascular disorders | ||||||||||
Hypertension | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/33 (6.1%) | 3/24 (12.5%) |
Limitations/Caveats
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 |
---|---|
Organization | FivePrime Theraputics |
Phone | 415-365-5600 |
nick.mahasuwan@fiveprime.com |
- FPA008-002