drugset / Trial / NCT01478685
A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in subjects with relapsed or refractory solid tumors.
Timeline
- Start
- 2011-11-29
- Primary completion
- 2015-11-17
- Completion
- 2015-11-17
Publications
- Background LoRusso P, et al. A Phase Ib study of CC-486 (Oral Azacitidine) as a priming agent for carboplatin or NAB-paclitaxel in subjects with relapsed and refractory solid tumors . Presented at 25th AACR-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics, October 19-23, 2013, Boston, MA. Abstract No. A120.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ABI-007 | Unknown | 100 mg/m2 | Intravenous |
| Subject | CC-486 | Unknown | — | Oral |
| Subject | Carboplatin | Small molecule | — | Intravenous |