A Phase I Study of Ganetespib +/- Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma
Summary
The purpose of this study is to find out what effects, good and/or bad, that ganetespib and bortezomib has on you and your cancer. The investigators will determine the side effects of different dose levels of ganetespib when given alone and the effect it has on your cancer alone. The investigators will also determine the side effects of ganetespib at different dose levels when given in combination with bortezomib and the effect the combination has on your cancer. The study will measure levels of the drug in your blood and bone marrow as well. Bortezomib is a proteasome inhibitor that is approved by the US Food and Drug Administration (FDA) that is used for the treatment of multiple myeloma. The brand name for bortezomib is Velcade®. Ganetespib is considered "investigational" because it has not received approval from the Food and Drug Administration for general use, although it has been previously tested in humans.
Timeline
- Start
- 2012-01
- Primary completion
- 2015-09
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ganetespib | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Ganetespib | Small molecule | 120 mg/m2 | Intravenous |
| Subject | Ganetespib | Small molecule | 144 mg/m2 | Intravenous |
| Subject | Ganetespib | Small molecule | 173 mg/m2 | Intravenous |
| Background | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |