Trial Outcomes & Findings for Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2) (NCT NCT00638963)
NCT ID: NCT00638963
Last Updated: 2017-06-14
Results Overview
The analysis could not be performed due to low enrollment.
TERMINATED
PHASE2
6 participants
1 Year
2017-06-14
Participant Flow
Participant milestones
| Measure |
Temozolomide
Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
Observational
No temozolomide treatment
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Temozolomide
Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
Observational
No temozolomide treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2)
Baseline characteristics by cohort
| Measure |
Temozolomide
n=3 Participants
Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
Observational
n=3 Participants
No temozolomide treatment
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 YearThe analysis could not be performed due to low enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24, 38, and 52 weeksPFS was defined as the time interval from randomization to objective tumor progression or death from any cause. The analysis could not be performed due to low enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24, 38, and 52 weeksDFS was defined as the time interval from randomization to any relapse (loco-regional, contra-lateral, and/or distant). The analysis could not be performed due to low enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24, 38, and 52 weeksDDFS was defined as the time interval from randomization to only distant metastases (for example, bone, visceral organ, brain). The analysis could not be performed due to low enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24,38, and 52 weeksBRFS was defined as the time interval from randomization to the appearance of brain metastases. The analysis could not be performed due to low enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 24 WeeksThis outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
Outcome measures
| Measure |
Temozolomide
n=3 Participants
Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
Observational
No temozolomide treatment
|
|---|---|---|
|
Number of Days on Temozolomide Treatment
|
75 Days
Standard Deviation 65.82 • Interval 1.0 to 127.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksThis outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
Outcome measures
| Measure |
Temozolomide
n=3 Participants
Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
Observational
No temozolomide treatment
|
|---|---|---|
|
Total Dose of Temozolomide Taken
|
9791.9 Milligrams
Standard Deviation 8732.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksThis outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
Outcome measures
| Measure |
Temozolomide
n=3 Participants
Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
Observational
No temozolomide treatment
|
|---|---|---|
|
Number of Participants Who Had at Least One Dose Reduction During Treatment
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksThis outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
Outcome measures
| Measure |
Temozolomide
n=3 Participants
Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
Observational
No temozolomide treatment
|
|---|---|---|
|
Number of Participants Who Had at Least One Treatment Omission During Treatment
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksThis outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
Outcome measures
| Measure |
Temozolomide
n=3 Participants
Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
Observational
No temozolomide treatment
|
|---|---|---|
|
Number of Participants Who Completed the Third Cycle of Treatment
|
2 Participants
|
—
|
Adverse Events
Temozolomide
Observational
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Temozolomide
n=3 participants at risk
Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
Observational
n=3 participants at risk
No temozolomide treatment
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
|
General disorders
Asthenia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Chest pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigator (PI) agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. The PI further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication in accordance with provisions of laws related to protection of sensitive personal data and patentability of inventions.
- Publication restrictions are in place
Restriction type: OTHER