A Study of Pioglitazone and Carboplatin in Patients With Advanced Solid Tumors
A Phase I Study of Pioglitazone and Carboplatin in Patients With Advanced Solid Tumors
Sponsor: Dana-Farber Cancer Institute
A PHASE1 clinical study on Advanced Solid Tumor and Metastatic Solid Tumor, this trial is completed. The trial is conducted by Dana-Farber Cancer Institute and has accumulated 7 data snapshots since 2011. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)* 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.
* 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.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
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Sep 2024 — Present [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
▶ Show 2 earlier versions
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE1
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Aug 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Dana-Farber Cancer Institute
For direct contact, visit the study record on ClinicalTrials.gov .