Completed Clinical Trials

Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II)

By April 24, 2017 No Comments

Condition

Malignant Pleural Mesothelioma|Solid Tumors

Estimated Enrollment: 71

Age Group: 18 Years and older   (Adult, Senior)

Gender: All

Study Type: Interventional

Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment

Study ID Numbers: CBP08-01

Study First Received: June 16, 2008

Last Updated: December 19, 2012

Estimated Primary Completion Date: July 2012

 

Primary Outcome Measures:

Ph I: To determine the MTD of CBP501 + pemetrexed + cisplatin in patients with advanced solid tumors. Ph II: To evaluate the efficacy and safety profile of CBP501 + pemetrexed + cisplatin in patients with malignant pleural mesothelioma|Ph I: To determine the recommended CBP501 dose for exploration in the phase II part|Ph I: To undertake a preliminary characterization of the safety profile of the triplet combination|Ph I: Determine the pharmacokinetics of CBP501 when co-administered with cisplatin and pemetrexed and investigate any potential interactions|Ph I: To evaluate the pharmacodynamics of the triplet combination|Ph II: To characterize the efficacy according to Modified RECIST criteria, of cisplatin combined with pemetrexed in this patient population and to aid in formulation of the hypothesis for an eventual phase III trial|Ph II: To evaluate clinical benefit of patients|Ph II: To evaluate the pharmacodynamics of the combination|Ph II: Determine the pharmacokinetics of CBP501 when co-administered with cisplatin and pemetrexed and investigate any potential interactions (only in cycle 1 of the first 6 patients in each arm in the US only)

Sponsors and Collaborators:

CanBas Co. Ltd.

Website Link: https://ClinicalTrials.gov/show/NCT00700336

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