Advanced Solid TumorPhase 1NCT02133625
A Study of Pioglitazone and Carboplatin in Patients With Advanced Solid Tumors
A Phase 1 study testing carboplatin and pioglitazone in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Dana-Farber Cancer Institute at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- carboplatin and pioglitazone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: A Phase I Study of Pioglitazone and Carboplatin in Patients With Advanced Solid Tumors
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.
Read the detailed 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.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor
- Being tested
- carboplatin, pioglitazone
- Keywords
- Advanced solid tumor, Metastatic solid tumor
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Also called Paraplatin, CBDCA
pioglitazoneDrug
Also called Actos
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone and Carboplatin | Experimental | MTD Determination
* Pioglitazone: 45 mg Once Daily by mouth,Cycle 1Days 1-28; Subsequent cycles: Days 1-21
* Carboplatin:6 AUC IV 60 minute infusion (or per institutional policy) Cycle 1: Day 8; Subsequent cycles: Day 1 Receives: Drug: carboplatin; Drug: pioglitazone |
| MTD Expansion Carboplatin and Pioglitazone | Experimental | MTD Expansion:
* Carboplatin alone on cycle 1, day 1.
* Pioglitazone 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 Receives: Drug: carboplatin; Drug: pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of pioglitazone and carboplatin
To determine the safety, tolerability, and MTD of the combination of pioglitazone (dosed orally once daily at conventional FDA-approved doses) and carboplatin (dosed IV every 3 weeks) in patients with advanced or metastatic solid malignancies. The trial will describe the toxicities of this regimen based on CTCAE. In addition, using RECIST criteria, will look at preliminary anti-tumor activity
Measured: Baseline, 6 Weeks
Secondary outcomes (3)
Plasma Concentration-time Profiles
The Wilcoxon Signed Rank test will be used to determine whether the addition of pioglitazone (at cycle 2) affects carboplatin pharmacokinetics and pharmacodynamics (assessed during cycle 1 of the MTD cohort). The Wilcoxon Signed Rank test will be used to determine whether the addition of pioglitazone (at cycle 2) affects carboplatin pharmacokinetics and pharmacodynamics (assessed during cycle 1 of the MTD cohort).
Measured: 5 minutes pre dosing, at 15 min and 30 min after beginning the infusion, 2 min before the end of the approximately 60 min infusion, and at approximately 30 min, 1 h, 2 h, 4 h, 6 h, and 24 h after the end of the infusion
Induction Rate of metallothionein expression and DNA damage by carboplatin in the absence or presence of pioglitazone.
To assess induction of metallothionein expression and DNA damage by carboplatin in the absence or presence of pioglitazone. In depth, molecular analysis measuring protein levels of tumor biopsy specimen will be performed to look for molecular predictors of response
Measured: Day 2
Anti-Tumor Response and Progression Rate
To assess preliminary anti-tumor activity of the combination of pioglitazone and carboplatin. We will use RECIST criteria to measure the response rate.
Measured: Baseline, ≥ 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startAug 2011
- Primary completionMar 2016
- Study completionJan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Cleary, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- James Cleary, MD, PhD, Principal investigator, Dana Farber Cancer Instiute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133625
- Sponsor's protocol ID
- 11-096
- Status last verified
- May 2016
- First submitted
- 9 Feb 2014
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Pioglitazone and Carboplatin in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02133625
- Acronym / sponsor ID
- 11-096
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor
- Keywords
- Advanced solid tumor, Metastatic solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jan 2026 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone and Carboplatin | Experimental | Drug: carboplatin, Drug: pioglitazoneMTD Determination * Pioglitazone: 45 mg Once Daily by mouth,Cycle 1Days 1-28; Subsequent cycles: Days 1-21 * Carboplatin:6 AUC IV 60 minute infusion (or per institutional policy) Cycle 1: Day 8; Subsequent cycles: Day 1 |
| MTD Expansion Carboplatin and Pioglitazone | Experimental | Drug: carboplatin, Drug: pioglitazoneMTD Expansion: * Carboplatin alone on cycle 1, day 1. * Pioglitazone 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Able to swallow oral medication.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatinAlso: Paraplatin, CBDCA | Drug | MTD Expansion Carboplatin and Pioglitazone, Pioglitazone and Carboplatin |
| pioglitazoneAlso: Actos | Drug | MTD Expansion Carboplatin and Pioglitazone, Pioglitazone and Carboplatin |
Primary outcome
MTD of pioglitazone and carboplatin
Time frame: Baseline, 6 Weeks
To determine the safety, tolerability, and MTD of the combination of pioglitazone (dosed orally once daily at conventional FDA-approved doses) and carboplatin (dosed IV every 3 weeks) in patients with advanced or metastatic solid malignancies. The trial will describe the toxicities of this regimen based on CTCAE. In addition, using RECIST criteria, will look at preliminary anti-tumor activity
3 secondary outcomes
Plasma Concentration-time Profiles
Time frame: 5 minutes pre dosing, at 15 min and 30 min after beginning the infusion, 2 min before the end of the approximately 60 min infusion, and at approximately 30 min, 1 h, 2 h, 4 h, 6 h, and 24 h after the end of the infusion
Induction Rate of metallothionein expression and DNA damage by carboplatin in the absence or presence of pioglitazone.
Time frame: Day 2
Anti-Tumor Response and Progression Rate
Time frame: Baseline, ≥ 4 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Cleary, MD, PhD principal investigator
Dana Farber Cancer Instiute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carboplatin and pioglitazone in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD of pioglitazone and carboplatin (time frame: Baseline, 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.