Diabetes drug plus chemo shows promise in early cancer trial
NCT ID NCT02133625
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested the safety of combining pioglitazone (a diabetes drug) with carboplatin (a chemotherapy) in 14 people with advanced solid tumors that could not be cured with standard treatments. The goal was to find the best dose and see if the combination is safe. Researchers also looked for early signs of anti-tumor activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pioglitazone and carboplatin
- What this could lead to
- If successful, this could point toward a new combination treatment for advanced solid tumors that are not curable with standard therapies.
- What could go wrong
- This is a very early phase 1 trial with only 14 participants, focused on safety and dosing. It is too small to prove effectiveness, and the combination may not work or may cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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14 people
The number who actually took part.
- Start date
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Aug 2011
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed malignancy that is not curable with standard approaches and where carboplatin is appropriate therapy. * During Part I of the trial (MTD determining phase), measurable or evaluable disease is acceptable. For Part II of the trial (expanded cohort) only, participants must have measurable disease by RECIST criteria version 1.1. * Participants enrolled in Part II of the trial (expanded cohort) must have disease that is amenable to biopsy with reasonable safety and also be willing to undergo at least two serial tumor biopsies for correlative biomarker investigation as defined in Section 8.2.2. * Any number of prior therapies are permitted. Prior carboplatin is allowed. Patients who have documented allergy to carboplatin may receive carboplatin with desensitization. * Age ≥18 years old. * ECOG performance status ≤ 1 (Appendix A). * Participants must have normal organ and marrow function as defined below: * Absolute neutrophil count ≥1,500/L * Hematocrit ≥ 27 * Platelets ≥100,000/L * Total bilirubin within normal institutional limits * AST (SGOT)/ALT (SGPT)≤ 2.5 X institutional upper limit of normal * Creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal. * Able to swallow oral medication. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study. * Subjects who have been treated with standard chemotherapy or molecularly targeted agents within the past 3 weeks prior to trial first drug administration. * Subjects who were receiving experimental therapies must wait 3 weeks from their last dose prior to enrolling. Subjects treated with nitrosoureas or mitomycin C cannot be enrolled until 6 weeks has elapsed since their last treatment. * Extensive prior radiotherapy on more than 25% of the bone marrow, or prior bone marrow/stem cell transplantation. Prior radiation for local disease management is allowed if last fraction was completed at least 4 weeks prior to trial entry. * Subjects who have undergone a major surgical procedure within the 6 weeks prior to trial entry. * History of untreated central nervous system (CNS) metastases. Subjects with a history of prior treated brain metastasis are eligible provided that 1 month following treatment they are stable by CT scan without evidence of cerebral edema, and have no requirements for corticosteroids. * Diabetic patients who are currently requiring oral hypoglycemic agents or insulin therapy. * Patients who are currently receiving rosiglitazone or pioglitazone, or who have received dosing with any other agent known to be a PPAR agonist within 3 months prior to study entry. * Left ventricular ejection fraction ≤ 50% on ECHO or MUGA * Uncontrolled concomitant illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or nursing women. * Known HIV positivity, active hepatitis C, or active hepatitis B. * Patients with ≥ CTCAE Grade 2 peripheral neuropathy. * Subjects with a known history of gastrointestinal disorder (such as partial esophageal, gastric, small or large bowel obstruction), surgery or malabsorption that could potentially impact the swallowing or the absorption of the study drug. * Patients taking CYP2C8 inhibitors and inducers (rifampin, gemfibrozil, trimethoprim, montelukast, and quercetin) are excluded from the trial. * Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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