deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT02133625

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

Updated 7 times since 2017 Last updated: May 12, 2016 Started: Aug 31, 2011 Primary completion: Jan 31, 2016 Completion: Jan 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Present [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

  2. 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

Sponsor contact:
  • Dana-Farber Cancer Institute
Data source: Dana-Farber Cancer Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations