Advanced Solid Tumors Clinical Trial
Official title:
An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Paclitaxel and Carboplatin Every 3 Weeks in Patients With Advanced Solid Tumors
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
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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