drugset / Trial / NCT00499239
A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study in sequential dose cohorts. Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and may receive a total of six treatment cycles based on toxicities and response. Patients who demonstrate disease progression will be discontinued from the study. Patients who, at the completion of six treatment cycles, tolerate treatment and show evidence of disease control (response or stabilization) will be eligible to continue receiving treatment at the same dose.
Timeline
- Start
- 2007-07
- Primary completion
- 2010-07
- Completion
- 2010-10
Outcome
Outcome not reported
Stopped: “Unacceptable safety profile”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RABACFOSADINE | Small molecule | 5 mg/m2 | Intravenous |
| Subject | RABACFOSADINE | Small molecule | 8 mg/m2 | Intravenous |
| Subject | RABACFOSADINE | Small molecule | 11.5 mg/m2 | Intravenous |
| Subject | RABACFOSADINE | Small molecule | 16 mg/m2 | Intravenous |
| Subject | RABACFOSADINE | Small molecule | 22.5 mg/m2 | Intravenous |
| Subject | RABACFOSADINE | Small molecule | 31.5 mg/m2 | Intravenous |
| Subject | RABACFOSADINE | Small molecule | 44 mg/m2 | Intravenous |
| Subject | RABACFOSADINE | Small molecule | 61.5 mg/m2 | Intravenous |