Trial Outcomes & Findings for AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin (NCT NCT00147225)
NCT ID: NCT00147225
Last Updated: 2014-05-08
Results Overview
Number of participants experiencing an adverse event (AE) or serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles
Results posted on
2014-05-08
Participant Flow
Recruitment Period: 08/04/05 to 04/09/12. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Of the 55 participants enrolled, one participant was enrolled but was a screen failure and another three withdrew without receiving any study drug thus were excluded from the trial demographics.
Participant milestones
| Measure |
1 mcg/kg AMG 531 Post Chemotherapy
Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. Adriamycin /Ifosfamide (AI) regimens \[Adriamycin (Doxorubicin) 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2
|
3 mcg/kg AMG 531 Post Chemotherapy
Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.
|
10 mcg/kg AMG 531 Post Chemotherapy
Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.
|
10 mcg/kg Pre/Post Chemotherapy
Cycle 1, Chemotherapy (Control Cycle); Beginning Cycle 2, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy (post dose) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.
|
5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.
|
10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
8
|
11
|
11
|
12
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
1 mcg/kg AMG 531 Post Chemotherapy
Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. Adriamycin /Ifosfamide (AI) regimens \[Adriamycin (Doxorubicin) 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2
|
3 mcg/kg AMG 531 Post Chemotherapy
Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.
|
10 mcg/kg AMG 531 Post Chemotherapy
Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.
|
10 mcg/kg Pre/Post Chemotherapy
Cycle 1, Chemotherapy (Control Cycle); Beginning Cycle 2, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy (post dose) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.
|
5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.
|
10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.
Chemotherapy :
1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Screen Failure
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Chemotherapy Changed
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin
Baseline characteristics by cohort
| Measure |
1 mcg/kg AMG 531 Post Chemotherapy
n=6 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
3 mcg/kg AMG 531 Post Chemotherapy
n=6 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
10 mcg/kg AMG 531 Post Chemotherapy
n=6 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
10 mcg/kg Pre/Post Chemotherapy
n=11 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy
|
5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
n=10 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)
|
10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
n=12 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
50 years
n=7 Participants
|
31 years
n=5 Participants
|
37 years
n=4 Participants
|
46 years
n=21 Participants
|
49 years
n=8 Participants
|
43 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
11 participants
n=4 Participants
|
10 participants
n=21 Participants
|
12 participants
n=8 Participants
|
51 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cyclesPopulation: All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.
Number of participants experiencing an adverse event (AE) or serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study.
Outcome measures
| Measure |
1 mcg/kg AMG 531 Post Chemotherapy
n=6 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
3 mcg/kg AMG 531 Post Chemotherapy
n=6 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
10 mcg/kg AMG 531 Post Chemotherapy
n=6 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
10 mcg/kg Pre/Post Chemotherapy
n=11 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy
|
5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
n=10 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)
|
10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
n=12 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy
Adverse Events, Possible or Probable
|
0 participants
|
0 participants
|
1 participants
|
4 participants
|
5 participants
|
8 participants
|
|
Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy
Serious Adverse Events, Possible or Probable
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy
Total Adverse Events
|
0 participants
|
0 participants
|
2 participants
|
4 participants
|
7 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cyclesPopulation: All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.
Number of participants experiencing an venous thromboembolism (VTE) related serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study. VTE events reported are part or whole total number reported for study SAEs, not in addition to SAEs reported.
Outcome measures
| Measure |
1 mcg/kg AMG 531 Post Chemotherapy
n=6 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
3 mcg/kg AMG 531 Post Chemotherapy
n=6 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
10 mcg/kg AMG 531 Post Chemotherapy
n=6 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
10 mcg/kg Pre/Post Chemotherapy
n=11 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy
|
5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
n=10 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)
|
10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
n=12 Participants
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)
|
|---|---|---|---|---|---|---|
|
Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy
Pulmonary Embolism (PE)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy
Deep Vein Thrombosis (DVT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy
Total VTE Related SAEs
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
Adverse Events
1 mcg/kg AMG 531 Post Chemotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 mcg/kg AMG 531 Post Chemotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10 mcg/kg AMG 531 Post Chemotherapy
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
10 mcg/kg Pre/Post Chemotherapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mcg/kg AMG 531 Post Chemotherapy
n=6 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
3 mcg/kg AMG 531 Post Chemotherapy
n=6 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
10 mcg/kg AMG 531 Post Chemotherapy
n=6 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
10 mcg/kg Pre/Post Chemotherapy
n=11 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy
|
5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
n=10 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)
|
10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
n=12 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
16.7%
1/6 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/11 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
10.0%
1/10 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/12 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/11 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
10.0%
1/10 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/12 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
Other adverse events
| Measure |
1 mcg/kg AMG 531 Post Chemotherapy
n=6 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
3 mcg/kg AMG 531 Post Chemotherapy
n=6 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
10 mcg/kg AMG 531 Post Chemotherapy
n=6 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later
|
10 mcg/kg Pre/Post Chemotherapy
n=11 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy
|
5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
n=10 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)
|
10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy
n=12 participants at risk
Cycle 1: Chemotherapy
Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
9.1%
1/11 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
10.0%
1/10 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
8.3%
1/12 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
9.1%
1/11 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/10 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
8.3%
1/12 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
|
General disorders
Flu-Like Symptoms
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/11 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/10 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
8.3%
1/12 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
|
Skin and subcutaneous tissue disorders
Skin/rash
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/11 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
10.0%
1/10 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
8.3%
1/12 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
|
Musculoskeletal and connective tissue disorders
Cramp
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/11 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
20.0%
2/10 • Number of events 2 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
8.3%
1/12 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
|
General disorders
Pain, Bone
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/11 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
20.0%
2/10 • Number of events 2 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
25.0%
3/12 • Number of events 3 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
9.1%
1/11 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
10.0%
1/10 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
33.3%
4/12 • Number of events 4 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
|
Blood and lymphatic system disorders
Thrombocytosis (>/= 1,000,000/mm^3)
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
16.7%
1/6 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
18.2%
2/11 • Number of events 2 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
10.0%
1/10 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
25.0%
3/12 • Number of events 3 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
|
General disorders
Headache
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/6 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/11 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
0.00%
0/10 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
8.3%
1/12 • Number of events 1 • Adverse events reported once the participant received their first dose of study drug, AMG 531 in Cycle 2 up to 6 cycles. Cycles were 21 to 28 days. The total study period was from August 5, 2005 to May 11, 2012.
|
Additional Information
Dr. Saroj Vadhan-Raj
University of Texas MD Anderson Cancer Center
Phone: 713-792-7966
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place