A Study of Pioglitazone and Carboplatin in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title: A Phase I Study of Pioglitazone and Carboplatin in Patients With Advanced Solid Tumors

Status Completed

Clinical Trial Summary

The proposed investigation is a Phase 1 trial to determine the safety, tolerability, and maximum tolerated dose (MTD) of the combination of pioglitazone ( and carboplatin patients with advanced or metastatic solid malignancies.

Clinical Trial Description

• In Part I of the study, the maximum tolerated dose (MTD) will be determined. During part I, Cycle 1, days 1-28, pioglitazone will be administered once daily. On cycle 1, day 8, the first dose of carboplatin will be administered. On cycle 2, day 1, both carboplatin and pioglitazone will be administered. Cycles 2 and onward are 21-day cycles, with pioglitazone administered once daily and carboplatin administered once every 3 weeks. Part I of the study will end when the MTD has been determined in a minimum of 6 patients.

• In Part II of the trial, an MTD Expansion Cohort may be utilized to further characterize the safety profile and pharmacodynamics of the drug. Patients in the MTD Expansion Cohort will receive carboplatin alone on cycle 1, day 1. Over days 15-21 of the cycle pioglitazone will be administered alone. On cycle 2, day 1, both carboplatin and pioglitazone will be administered.

Cycle 2 and onward are 21-day cycles, with pioglitazone administered once daily and carboplatin administered once every 3 weeks. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Neoplasms

• NCT number: NCT02133625
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 1
• Start date: August 2011
• Completion date: January 2016