Trial Outcomes & Findings for Fosaprepitant in Patients Receiving Ifosfamide-based Regimen (NCT NCT01490060)
NCT ID: NCT01490060
Last Updated: 2016-04-11
Results Overview
Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).
Results posted on
2016-04-11
Participant Flow
Recruitment Period: May 21, 2012 to January 23, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Arm A: Single Dose, Group 1
Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
|
Arm A: Single Dose, Group 2
Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
|
Arm B: Two Doses, Group 1
Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
|
Arm B: Two Doses, Group 2
Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
|
|---|---|---|---|---|
|
Cycle 1
STARTED
|
11
|
13
|
12
|
11
|
|
Cycle 1
COMPLETED
|
11
|
12
|
9
|
8
|
|
Cycle 1
NOT COMPLETED
|
0
|
1
|
3
|
3
|
|
Cycle 2
STARTED
|
11
|
12
|
9
|
8
|
|
Cycle 2
COMPLETED
|
9
|
11
|
8
|
8
|
|
Cycle 2
NOT COMPLETED
|
2
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Single Dose, Group 1
Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
|
Arm A: Single Dose, Group 2
Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
|
Arm B: Two Doses, Group 1
Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
|
Arm B: Two Doses, Group 2
Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
|
|---|---|---|---|---|
|
Cycle 1
Change of Treatment
|
0
|
1
|
1
|
1
|
|
Cycle 1
Insurance Denied
|
0
|
0
|
2
|
0
|
|
Cycle 1
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Cycle 1
Treatment at Another Facility
|
0
|
0
|
0
|
1
|
|
Cycle 2
Change of Treatment
|
1
|
1
|
0
|
0
|
|
Cycle 2
Non-Compliance
|
0
|
0
|
1
|
0
|
|
Cycle 2
Adverse Event Related to Chemotherapy
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Fosaprepitant in Patients Receiving Ifosfamide-based Regimen
Baseline characteristics by cohort
| Measure |
Arm A: Single Dose, Day 1
n=24 Participants
Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
|
Arm B: Two Doses, Day 1 + Day 4
n=23 Participants
Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 19 and 65 years
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).Population: Out of 40 eligible participants, 2 participants had change of treatment, 1 participant was noncompliant and 1 participant had an adverse event related to chemotherapy. 36 participants completed cycle 1 and cycle 2.
Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.
Outcome measures
| Measure |
Control Cycle (Arm A/Arm B)
n=36 Participants
Control cycle without fosaprepitant.
|
Arm A: Single Dose, Day 1
n=20 Participants
Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
|
Arm B: Two Doses, Day 1 + Day 4
n=16 Participants
Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
|
|---|---|---|---|
|
Complete Response
|
17 percentage of participants
|
10 percentage of participants
|
50 percentage of participants
|
Adverse Events
Control Cycle (Arm A/Arm B)
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Arm A: Single Dose, Day 1
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Arm B: Two Doses, Day 1 + Day 4
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Cycle (Arm A/Arm B)
n=37 participants at risk
Control cycle without fosaprepitant.
|
Arm A: Single Dose, Day 1
n=22 participants at risk
Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
|
Arm B: Two Doses, Day 1 + Day 4
n=17 participants at risk
Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
|
|---|---|---|---|
|
General disorders
Neutropenic Fever
|
10.8%
4/37 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
4.5%
1/22 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
Other adverse events
| Measure |
Control Cycle (Arm A/Arm B)
n=37 participants at risk
Control cycle without fosaprepitant.
|
Arm A: Single Dose, Day 1
n=22 participants at risk
Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
|
Arm B: Two Doses, Day 1 + Day 4
n=17 participants at risk
Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
16.2%
6/37 • Number of events 6 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
4.5%
1/22 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
0.00%
0/17 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
Gastrointestinal disorders
Constipation
|
51.4%
19/37 • Number of events 19 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
40.9%
9/22 • Number of events 9 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
52.9%
9/17 • Number of events 9 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
Gastrointestinal disorders
Anorexia
|
59.5%
22/37 • Number of events 22 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
54.5%
12/22 • Number of events 12 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
17.6%
3/17 • Number of events 3 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
General disorders
Fatigue
|
67.6%
25/37 • Number of events 25 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
54.5%
12/22 • Number of events 12 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
47.1%
8/17 • Number of events 8 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
2/37 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
9.1%
2/22 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
23.5%
4/17 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
General disorders
Chills
|
18.9%
7/37 • Number of events 7 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
27.3%
6/22 • Number of events 6 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
29.4%
5/17 • Number of events 5 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
General disorders
Headache
|
24.3%
9/37 • Number of events 9 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
22.7%
5/22 • Number of events 5 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
23.5%
4/17 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
Nervous system disorders
Memory Impairment
|
8.1%
3/37 • Number of events 3 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
4.5%
1/22 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
11.8%
2/17 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
Nervous system disorders
Paresthesia
|
10.8%
4/37 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
9.1%
2/22 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
11.8%
2/17 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.5%
5/37 • Number of events 5 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
18.2%
4/22 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
11.8%
2/17 • Number of events 2 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
General disorders
Pain
|
13.5%
5/37 • Number of events 5 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
18.2%
4/22 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
17.6%
3/17 • Number of events 3 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
General disorders
Alopecia
|
27.0%
10/37 • Number of events 10 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
22.7%
5/22 • Number of events 5 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
5.9%
1/17 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
|
Eye disorders
Eye Disorders
|
16.2%
6/37 • Number of events 6 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
13.6%
3/22 • Number of events 3 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
35.3%
6/17 • Number of events 6 • Adverse events (AEs) and Serious Adverse Events (SAEs) were assessed in two 21-days cycles (Cycle 1 and Cycle 2). Collection period: May 23, 2012 to June 11, 2014.
Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].
|
Additional Information
Saroj Vadhan-Raj, MD/Professor, Sarcoma Medical Oncology
University of Texas (UT) 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