Trials / Completed
CompletedNCT00831545
Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064)
Multicenter Phase 2 Evaluation of Temozolomide for Treatment of Brain Metastases of Either Malignant Melanoma, Breast and Non-small Cell Lung Cancer.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 162 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The study implies a 2 step study design. Patients are enrolled into 3 separate groups for melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease group are enrolled. If \>=2 objective responses (SD, PR, or CR) out of 21 evaluable patients are observed, enrollment continues for other 45 patients as a whole, where response will be positively evaluated if \>=10 patients will respond. If \<2 objective responses out of 21 evaluable patients per disease group are observed, this(ese) group(s) will no longer be treated with temozolomide.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Temozolomide | 150 mg/m2 given once a day for 7 consecutive days (Days 1 through 7) repeated every other week until disease progression or toxicity or for a maximum of one year. After amendment, schedule was modified: a second rest week was added after the second wash-out week (Days 1 through 7, 15 through 21 every 35). |
Timeline
- Start date
- 2000-12-01
- Primary completion
- 2006-10-20
- Completion
- 2006-10-20
- First posted
- 2009-01-29
- Last updated
- 2017-05-09
Source: ClinicalTrials.gov record NCT00831545. Inclusion in this directory is not an endorsement.