drugset / Trial / NCT01293630
A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors. Secondary Objectives: * To assess the overall safety profiles of the combination therapy * To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, paclitaxel, and carboplatin when used in combination * To document the objective tumor response
Timeline
- Start
- 2011-01
- Primary completion
- 2013-10
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Ombrabulin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Ombrabulin | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Ombrabulin | Other / unclassified | 35 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |