An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01137006
Collaborator
(none)
27
2
2
26
13.5
0.5
Study Details
Study Description
Brief Summary
A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
27 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Dose-Escalation Phase 1/1b Study of the Anti-gp75 Monoclonal Antibody IMC-20D7S In Patients With Malignant Melanoma Who Have Progressed After or During at Least One Treatment With Standard Cytotoxic Treatment or/and Immunotherapy Therapy or For Whom Standard Therapy is Not Indicated
Study Start Date
:
Jun 1, 2010
Actual Primary Completion Date
:
Aug 1, 2012
Actual Study Completion Date
:
Aug 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IMC-20D7S (1A-4A Cohorts) Escalating doses up to 30 milligrams per kilogram (mg/kg) administered intravenously (i.v.) every 2 weeks; includes Cohorts 1A, 2A, 3A, and 4A. |
Biological: IMC-20D7S (Cohort 1A)
5 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A.
Other Names:
Biological: IMC-20D7S (Cohort 2A)
10 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A.
Other Names:
Biological: IMC-20D7S (Cohort 3A)
20 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A.
Other Names:
Biological: IMC-20D7S (Cohort 4A)
30 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
Other Names:
|
| Experimental: IMC-20D7S (1B-3B Cohorts) Escalating doses up to 30 mg/kg administered i.v. every 3 weeks; includes Cohorts 1B, 2B, and 3B. |
Biological: IMC-20D7S (Cohort 1B)
10 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B.
Other Names:
Biological: IMC-20D7S (Cohort 2B)
20 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B.
Other Names:
Biological: IMC-20D7S (Cohort 3B)
30 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose (MTD) of IMC-20D7S [Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]]
The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.
- Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death [Baseline through 30 days post last dose (up to 31 weeks)]
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Secondary Outcome Measures
- IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax) [Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.]
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
- IMC-20D7S PK: Minimal Concentration (Cmin) [Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.]
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
- IMC-20D7S PK: Half-life (t½) [Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.]
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
- IMC-20D7S PK: Clearance (Cl) [Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.]
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
- IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC) [Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.]
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
- IMC-20D7S PK: Volume of Distribution (Vd) at Steady State [Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.]
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
- Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity) [Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles)]
Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses.
- Progression-Free Survival (PFS) [First dose to disease progression or death (up to 27 weeks)]
PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3.
- Recommend Doses for Phase 2/3 Studies Based on MTD [Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)]]
It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy [for example (e.g.), treatment with cytokines, monoclonal antibodies, and vaccines] and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma
-
Participant is ≥18 years of age
-
Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease
-
At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
-
Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02)
-
Participant has adequate hematological function, hepatic function, and renal function
Exclusion Criteria:
-
Participant has undergone major surgery [e.g., laparotomy, thoracotomy, removal of organ(s)] within 21 days prior to study entry
-
Participant has elective or planned surgery to be conducted during the trial
-
Participant has documented and/or symptomatic brain or leptomeningeal metastases
-
Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted)
-
Participant has an uncontrolled undercurrent illness
-
Participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm
-
Participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded
-
Participant is pregnant or lactating
-
Participant has known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ImClone Investigational Site | Boston | Massachusetts | United States | 02114 |
| 2 | ImClone Investigational Site | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: E-mail: ClinicalTrials@ ImClone.com, Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01137006
Other Study ID Numbers:
- 13945
- CP22-0901
- I4Z-IE-JDEA
First Posted:
Jun 4, 2010
Last Update Posted:
Jun 17, 2019
Last Verified:
Mar 1, 2019
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A completed participant (pt) finished the first 4 or 6 weeks of therapy or discontinued due to toxicity. Cohort (C)1A pts were treated sequentially. The next cohort started when all pts finished Cycle 1 of current cohort. Cohorts 1B-3B started if supported by C1A and C2A pharmacokinetic (PK) data and if maximum tolerated dose (MTD) not established. |
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 milligrams per kilogram (mg/kg) IMC-20D7S administered intravenously (i.v.) as an infusion every other week (q2w) on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion every three weeks (q3w) on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Period Title: Overall Study | |||||||
| STARTED | 3 | 3 | 8 | 3 | 3 | 4 | 3 |
| Completed at Least 1 Treatment Cycle | 3 | 3 | 8 | 3 | 3 | 4 | 3 |
| COMPLETED | 3 | 3 | 8 | 3 | 3 | 4 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | Total of all reporting groups |
| Overall Participants | 3 | 3 | 8 | 3 | 3 | 4 | 3 | 27 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
77.7
(5.50)
|
64.9
(4.92)
|
69.8
(8.37)
|
61.1
(11.70)
|
66.6
(4.41)
|
69.1
(5.53)
|
65.4
(18.90)
|
68.2
(9.26)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
2
66.7%
|
1
33.3%
|
3
37.5%
|
1
33.3%
|
1
33.3%
|
1
25%
|
2
66.7%
|
11
40.7%
|
| Male |
1
33.3%
|
2
66.7%
|
5
62.5%
|
2
66.7%
|
2
66.7%
|
3
75%
|
1
33.3%
|
16
59.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.7%
|
| Not Hispanic or Latino |
3
100%
|
3
100%
|
7
87.5%
|
3
100%
|
3
100%
|
4
100%
|
3
100%
|
26
96.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 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%
|
| Asian |
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.7%
|
| White |
2
66.7%
|
2
66.7%
|
8
100%
|
3
100%
|
3
100%
|
4
100%
|
3
100%
|
25
92.6%
|
| More than one race |
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%
|
| Region of Enrollment (participants) [Number] | ||||||||
| United States |
3
100%
|
3
100%
|
8
100%
|
3
100%
|
3
100%
|
4
100%
|
3
100%
|
27
100%
|
Outcome Measures
| Title | Maximum Tolerated Dose (MTD) of IMC-20D7S |
|---|---|
| Description | The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established. |
| Time Frame | Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)] |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed Cycle 1 of treatment. |
| Arm/Group Title | IMC-20D7S |
|---|---|
| Arm/Group Description | IMC-20D7S: Escalating doses (up to 30 mg/kg IMC-20D7S) administered i.v. as an infusion either q2w on Days 1 and 15 of each 4-week treatment cycle or q3w on Days 1 and 22 of each 6-week treatment cycle. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 27 |
| Number [mg/kg q2w] |
20
|
| Title | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death |
|---|---|
| Description | A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. |
| Time Frame | Baseline through 30 days post last dose (up to 31 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of IMC-20D7S . |
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 3 | 3 | 8 | 3 | 3 | 4 | 3 |
| SAEs |
1
33.3%
|
1
33.3%
|
5
62.5%
|
2
66.7%
|
0
0%
|
4
100%
|
0
0%
|
| Other Non-Serious AEs |
3
100%
|
3
100%
|
8
100%
|
3
100%
|
2
66.7%
|
4
100%
|
3
100%
|
| Deaths |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax) |
|---|---|
| Description | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Time Frame | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed. |
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | IMC-20D7S PK: Minimal Concentration (Cmin) |
|---|---|
| Description | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Time Frame | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed. |
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | IMC-20D7S PK: Half-life (t½) |
|---|---|
| Description | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Time Frame | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed. |
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | IMC-20D7S PK: Clearance (Cl) |
|---|---|
| Description | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Time Frame | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed. |
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC) |
|---|---|
| Description | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Time Frame | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed. |
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | IMC-20D7S PK: Volume of Distribution (Vd) at Steady State |
|---|---|
| Description | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Time Frame | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed. |
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity) |
|---|---|
| Description | Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses. |
| Time Frame | Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles) |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed. |
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Progression-Free Survival (PFS) |
|---|---|
| Description | PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3. |
| Time Frame | First dose to disease progression or death (up to 27 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who went beyond their first disease assessment and completed at least one treatment beyond Week 1 of treatment Cycle 3. |
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 3 | 3 | 8 | 3 | 3 | 4 | 3 |
| Number [participants] |
0
0%
|
3
100%
|
2
25%
|
1
33.3%
|
1
33.3%
|
1
25%
|
2
66.7%
|
| Title | Recommend Doses for Phase 2/3 Studies Based on MTD |
|---|---|
| Description | It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b. |
| Time Frame | Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)] |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed. |
| Arm/Group Title | IMC-20D7S |
|---|---|
| Arm/Group Description | IMC-20D7S: Escalating doses (up to 30 mg/kg IMC-20D7S) administered i.v. as an infusion either q2w on Days 1 and 15 of each 4-week treatment cycle or q3w on Days 1 and 22 of each 6-week treatment cycle. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) | |||||||
| Arm/Group Description | IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | |||||||
All Cause Mortality |
||||||||||||||
| Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) | ||||||||
| 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 | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
| Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) | ||||||||
| 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%) | 1/3 (33.3%) | 5/8 (62.5%) | 2/3 (66.7%) | 0/3 (0%) | 4/4 (100%) | 0/3 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal pain | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Gastritis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Melaena | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Mouth haemorrhage | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| General disorders | ||||||||||||||
| Disease progression | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/8 (25%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Pyrexia | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Infections and infestations | ||||||||||||||
| Pneumonia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Urinary tract infection | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||
| Subdural haematoma | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||
| Failure to thrive | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Hypoglycaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Hypophosphataemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Metastases to central nervous system | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Metastatic pain | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Nervous system disorders | ||||||||||||||
| Cerebral haemorrhage | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Syncope | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||
| Mental status changes | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||
| Haematuria | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Urinary bladder haemorrhage | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Dyspnoea | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Hypoxia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Pleural effusion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Vascular disorders | ||||||||||||||
| Deep vein thrombosis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Cohort 1A (5 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 4A (30 mg/kg, q2w) | Cohort 1B (10 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 3B (30 mg/kg, q3w) | ||||||||
| 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%) | 3/3 (100%) | 8/8 (100%) | 3/3 (100%) | 2/3 (66.7%) | 4/4 (100%) | 3/3 (100%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Anaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Thrombocytopenia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Cardiac disorders | ||||||||||||||
| Tachycardia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||||||||
| Ear discomfort | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Eye disorders | ||||||||||||||
| Eye pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Eye swelling | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||
| Abdominal distension | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Abdominal pain | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Breath odour | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Constipation | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 4/8 (50%) | 4 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 |
| Diarrhoea | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 2/3 (66.7%) | 3 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 |
| Dry mouth | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Gastric ulcer | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Gastrointestinal haemorrhage | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Gastrooesophageal reflux disease | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Nausea | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Stomatitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| General disorders | ||||||||||||||
| Catheter site pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Chills | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Cyst | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Disease progression | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Fatigue | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 4/8 (50%) | 5 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 2/3 (66.7%) | 3 |
| Feeling cold | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Influenza like illness | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Infusion related reaction | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Oedema peripheral | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 2 |
| Pyrexia | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Infections and infestations | ||||||||||||||
| Cellulitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Oral candidiasis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Otitis externa | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Upper respiratory tract infection | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||||
| Excoriation | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Postoperative fever | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Investigations | ||||||||||||||
| Weight increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||
| Decreased appetite | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Dehydration | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Hypercalcaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperuricaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Hypomagnesaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Hyponatraemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Hypophosphataemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 4 | 1/3 (33.3%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthralgia | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/8 (25%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 2/3 (66.7%) | 2 |
| Back pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Flank pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Joint swelling | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Muscle spasms | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Musculoskeletal pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/8 (25%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Neck pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 0/3 (0%) | 0 |
| Nodule on extremity | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Pain in extremity | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Pain in jaw | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Basal cell carcinoma | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Skin neoplasm bleeding | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Tumour pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Nervous system disorders | ||||||||||||||
| Cerebrovascular accident | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Dizziness | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 0/3 (0%) | 0 |
| Dysgeusia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Headache | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 0/3 (0%) | 0 |
| Neuropathy peripheral | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Peroneal nerve palsy | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 0/3 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||
| Insomnia | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||
| Haematuria | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||
| Penile oedema | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Scrotal oedema | 0/1 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Cough | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/8 (25%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Dyspnoea | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Dyspnoea exertional | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Nasal congestion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Oropharyngeal pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Pleural effusion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Postnasal drip | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Wheezing | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Dry skin | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperhidrosis | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Night sweats | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Pruritus | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Rash | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Rash macular | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Rash maculo-papular | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Rash vesicular | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Skin plaque | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Vitiligo | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Vascular disorders | ||||||||||||||
| Deep vein thrombosis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
| Flushing | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Haematoma | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01137006
Other Study ID Numbers:
- 13945
- CP22-0901
- I4Z-IE-JDEA
First Posted:
Jun 4, 2010
Last Update Posted:
Jun 17, 2019
Last Verified:
Mar 1, 2019