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Efficacy Study of CPC634 (CriPec® Docetaxel) in Platinum Resistant Ovarian Cancer — CINOVA  

Cancer Clinical Trial

Official title:
A Phase Ila Exploratory 2-stage Design Study of CPC634 (CriPec® Docetaxel) Monotherapy in Subjects With Platinum Resistant Ovarian Cancer.

Clinical Trial Summary

The purpose of this study is to determine whether CPC634 (CriPec® docetaxel) is effective in the treatment of patients with advanced epithelial ovarian cancer who are resistant to prior platinum-based chemotherapy .

Clinical Trial Description

This Phase IIa exploratory 2-stage trial assessed the efficacy, safety and tolerability of CPC634 (CriPec® docetaxel) administered IV, Q3W to 25 subjects (13 in Stage 1 and 12 in Stage 2) with ovarian cancer that is resistant to prior platinum-based therapy. Subjects will be treated continuously every 21 days at 60 mg/m2, which is the RP2D of CPC634 (CriPec® docetaxel) that was determined in the Phase I CT-CL01, until disease progression, unacceptable toxicity, or discontinuation for any other reason. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03742713
Study type Interventional
Source Cristal Therapeutics
Contact
Status Completed
Phase Phase 2
Start date October 1, 2018
Completion date December 1, 2020
View Details
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