Trial Outcomes & Findings for A Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Pediatric Participants With Advanced Solid Tumors (P05883, MK-7454-006) (NCT NCT00960063)
NCT ID: NCT00960063
Last Updated: 2018-08-27
Results Overview
Dose-limiting toxicity was defined by the following adverse events (AEs) that were considered possibly or probably related to either robatumumab or to its interaction with the chemotherapy regimen assigned: neutropenia (Grade 4 for \>1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 neutropenia with Grade ≥2 fever lasting 3 days; neutropenic infection; failure to recover to study entry/eligibility criteria laboratory requirement levels that resulted in a delay of 14 days between treatment cycles), thrombocytopenia (Grade 4 for \>1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 requiring a platelet transfusion on 2 separate days within a cycle) or all other AEs (Grade ≥3 \[any duration\] not ameliorable by supportive or symptomatic measures). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0) was to be used to grade AEs.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
Up to ~30 days after last dose of study drug (Up to ~10.3 months)
Results posted on
2018-08-27
Participant Flow
Participant milestones
| Measure |
Temozolomide+Irinotecan+Robatumumab
Participants receive temozolomide 100 mg/m\^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab
Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Ifosfamide+Etoposide+Robatumumab
Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
Temozolomide+Irinotecan+Robatumumab
Participants receive temozolomide 100 mg/m\^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab
Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Ifosfamide+Etoposide+Robatumumab
Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Progression of Disease
|
0
|
0
|
3
|
Baseline Characteristics
A Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Pediatric Participants With Advanced Solid Tumors (P05883, MK-7454-006)
Baseline characteristics by cohort
| Measure |
Temozolomide+Irinotecan+Robatumumab
n=1 Participants
Participants receive temozolomide 100 mg/m\^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab
Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Ifosfamide+Etoposide+Robatumumab
n=3 Participants
Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23.0 Years
STANDARD_DEVIATION 0.0 • n=5 Participants
|
—
|
8.3 Years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
12.0 Years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to ~30 days after last dose of study drug (Up to ~10.3 months)Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
Dose-limiting toxicity was defined by the following adverse events (AEs) that were considered possibly or probably related to either robatumumab or to its interaction with the chemotherapy regimen assigned: neutropenia (Grade 4 for \>1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 neutropenia with Grade ≥2 fever lasting 3 days; neutropenic infection; failure to recover to study entry/eligibility criteria laboratory requirement levels that resulted in a delay of 14 days between treatment cycles), thrombocytopenia (Grade 4 for \>1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 requiring a platelet transfusion on 2 separate days within a cycle) or all other AEs (Grade ≥3 \[any duration\] not ameliorable by supportive or symptomatic measures). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0) was to be used to grade AEs.
Outcome measures
| Measure |
Ifosfamide+Etoposide+Robatumumab
n=3 Participants
Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Temozolomide+Irinotecan+Robatumumab
n=1 Participants
Participants receive temozolomide 100 mg/m\^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab
Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
3 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Screening, every 6 weeks and at ~30 days after last dose of study drug (Up to ~10.3 months)Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were to be identified as target lesions. Data were to be collected at Screening, every 6 weeks and at 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last). The best overall response was to be the best response recorded from the start of the treatment until disease progression/recurrence. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): \>20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions; or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Ifosfamide+Etoposide+Robatumumab
n=3 Participants
Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Temozolomide+Irinotecan+Robatumumab
n=1 Participants
Participants receive temozolomide 100 mg/m\^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab
Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
|---|---|---|---|
|
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response (CR)
|
0 Participants
|
0 Participants
|
—
|
|
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response (PR)
|
2 Participants
|
1 Participants
|
—
|
|
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease (SD)
|
0 Participants
|
0 Participants
|
—
|
|
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease (PD)
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for Cmax were not produced.
Cmax was defined as the maximum observed serum concentration of robatumumab when administered in combination with other treatments. Blood samples for analysis of robatumumab pharmacokinetics (PK) were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGF-I were not produced.
IGF-I is produced largely by the liver in response to growth hormone from the hypothalamic-pituitary axis. The IGF ligands can promote neoplastic events (cancer growth) through a number of different mechanisms. Robatumumab inhibits IGF ligand binding, IGF-stimulated receptor phosphorylation and human tumor cell proliferation. Plasma levels of IGF-I were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to 1st and 8th doses of robatumumab, ~30 days after last dose of study drug, and 4 months after last dose of study drug (Up to ~13.3 months)Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy and had a negative pre-treatment sample and a post-treatment sample.
The incidence of anti-robatumumab antibodies was to be assessed. Only participants who had a negative pre-treatment sample and a post-treatment sample were considered to be evaluable. If a participant had a single sample considered positive in the anti-robatumumab antibody assay (with the exception of pre-treatment positive participants), then they would be counted as positive in the immunogenicity assessment.
Outcome measures
| Measure |
Ifosfamide+Etoposide+Robatumumab
n=2 Participants
Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Temozolomide+Irinotecan+Robatumumab
n=1 Participants
Participants receive temozolomide 100 mg/m\^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab
Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
|---|---|---|---|
|
Number of Participants Who Developed Anti-robatumumab Antibodies
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for Tmax were not produced.
Tmax was defined as time of Cmax of robatumumab when administered in combination with other treatments. Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for AUCtf were not produced.
AUCtf for robatumumab was defined as the area under the curve at the time of the final quantifiable sample of robatumumab. Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for AUCτ were not produced.
AUCτ was defined as the area under the plasma concentration-time curve during a dosage interval (τ). Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGF-II were not produced.
IGF-II is generally produced locally in response to growth hormone from the hypothalamic-pituitary axis. The IGF ligands can promote neoplastic events (cancer growth) through a number of different mechanisms. Robatumumab inhibits IGF ligand binding, IGF-stimulated receptor phosphorylation and human tumor cell proliferation. Plasma levels of IGF-II were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGFBP-2 were not produced.
The IGFBP-2 protein is secreted into the bloodstream where it binds to IGF-I and IGF-II. High expression levels of this protein promote the growth of several types of tumors and may be predictive of the chances of recovery of the participant. Robatumumab inhibits expression of this protein. Plasma levels of IGFBP-2 were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)Population: All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGFBP-3 were not produced.
The IGFBP-3 protein is secreted into the bloodstream where it binds to IGF-I and IGF-II. High expression levels of this protein promote the growth of several types of tumors and may be predictive of the chances of recovery of the participant. Robatumumab inhibits expression of this protein. Plasma levels of IGFBP-3 were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).
Outcome measures
Outcome data not reported
Adverse Events
Temozolomide+Irinotecan+Robatumumab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ifosfamide+Etoposide+Robatumumab
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide+Irinotecan+Robatumumab
n=1 participants at risk
Participants receive temozolomide 100 mg/m\^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab
Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Ifosfamide+Etoposide+Robatumumab
n=3 participants at risk
Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
100.0%
3/3 • Number of events 4 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
General disorders
Chills
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
Other adverse events
| Measure |
Temozolomide+Irinotecan+Robatumumab
n=1 participants at risk
Participants receive temozolomide 100 mg/m\^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab
Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
Ifosfamide+Etoposide+Robatumumab
n=3 participants at risk
Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
100.0%
3/3 • Number of events 18 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
100.0%
3/3 • Number of events 12 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Blood and lymphatic system disorders
Thromobocytopenia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
66.7%
2/3 • Number of events 13 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Ear and labyrinth disorders
Ear pain
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Endocrine disorders
Adrenal insufficiency
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Gastrointestinal disorders
Haemorrhoids
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Gastrointestinal disorders
Oral disorder
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
66.7%
2/3 • Number of events 2 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
General disorders
Cyst
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
66.7%
2/3 • Number of events 2 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
General disorders
Mass
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
General disorders
Pain
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Infections and infestations
Otitis media
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 6 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 8 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 4 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Nervous system disorders
Sinus headache
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Psychiatric disorders
Insomnia
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
100.0%
1/1 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
66.7%
2/3 • Number of events 2 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
66.7%
2/3 • Number of events 3 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
—
0/0 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to ~10.3 months)
All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER