drugset / Trial / NCT00361088
A Combination of Zarnestra With Velcade for Patients With Relapsed Multiple Myeloma
Phase 1/2
Terminated
42 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Millennium Pharmaceuticals, Inc. · collabNational Cancer Institute (NCI) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
In Phase I, patients will receive a combination of PS-341 (Velcade) and R115777 (Zarnestra) to determine the dose limiting toxicity (DLT). Once DLT is determined, patients in Phase II will be receive the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue if there is evidence of continued response for 8 cycles. Patients will receive follow up to include normal laboratory evaluations at least every 3 months and a skeletal survey will be performed at least every 6 months.
Timeline
- Start
- 2005-08
- Primary completion
- 2007-06
- Completion
- 2007-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | tipifarnib | Small molecule | 100 mg | Oral |
| Subject | tipifarnib | Small molecule | 200 mg | Oral |
| Subject | tipifarnib | Small molecule | 300 mg | Oral |