Non-Small-Cell Lung CancerPhase 2NCT00923949
Pioglitazone to Treat Adults Undergoing Surgery for Non-small Cell Lung Cancer
A Phase 2 study testing Pioglitazone in people with Non-Small-Cell Lung Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
Background: Pioglitazone is a drug that belongs to the class of antidiabetic agents called thiazolidinediones. It is approved for treatment of type 2 diabetes mellitus. Research suggests that the thiazolidinediones may have anticancer activity that can reduce cancer risk or cause tumors to shrink. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients with newly diagnosed stage Ia-IIb resectable non-small cell lung cancer who will be undergoing definitive surgery. If histologic confirmation of lung cancer has not previously been made, the baseline study bronchoscopy, as outlined in section 3.6.2, or computed tomography (CT)-guided biopsy with tissue saved for protocol use may be used to document NSCLC, after obtaining informed consent. Should the bronchoscopy or CT-guided biopsy be negative for non-small cell lung cancer (NSCLC), the patient will be taken off study prior to drug treatment. At National Cancer Institute (NCI), histologic confirmation of the diagnosis will be performed by the NCI Laboratory of Pathology.
- Age greater than or equal to 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
- Patients must have the capacity and willingness to sign a written informed consent and demonstrate willingness to comply with an oral regimen.
- The time between initial diagnosis and the scheduled surgery date allow for the subject to receive a minimum of 2 weeks or a maximum of 6 weeks treatment with pioglitazone. The maximum time between enrollment on this trial and surgery will be 6-weeks and there will be no delay between the end of pioglitazone treatment and surgery.
- Patients must have normal organ and marrow function as defined below:
Show all 18Show fewer
- absolute neutrophil count greater than or equal to 1,500/mL
- hemoglobin greater than 10 g/dL
- platelets greater than or equal to 100,000/mL
- Bilirubin less than 1.8 mg/dL
- aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 1.5 times upper limits of institutional normal
- creatinine less than 1.5 times upper limit of institutional normal
- 7. Patients must agree to swallow oral tablets.
- 8. Patients who will agree to undergo two bronchoscopies as detailed in section 3.6.2 (before treatment and at the time of surgery).
- For those patients who are undergoing mediastinoscopy as part of their standard-of-care, the pre-treatment bronchoscopy may be performed during the mediastinoscopy. If the patient remains eligible for definitive surgical resection after the mediastinoscopy, the patient may begin pioglitazone treatment on this protocol.
- 9. Females are eligible to participate in the study if
- She is of non-childbearing potential as defined by having had a hysterectomy, a bilateral oophorectomy, a bilateral tubal ligation, or having been post-menopausal for greater than or equal to 1 year.
- She is of childbearing potential and has a negative pregnancy test within 2 weeks of the starting the study drug and agrees to the use of non-hormonal methods of birth control, e.g., barrier methods, for the duration of the study due to possible drug interactions.
Who cannot join
- Pregnant or lactating women.
- Patients who are undergoing chemotherapy, treatment with biologic agents, or radiation therapy. Prior chemotherapy, biologic agent treatment, or radiation therapy, greater than 1 year ago, is allowed.
- Patients with greater than or equal to class II New York Heart Association (NYHA) congestive heart failure or history of congestive heart failure.
- Patients with greater than or equal to grade 2 (moderate) edema.
- Patients with diabetes mellitus being treated with insulin or any pharmacologic therapy.
- Patients taking gemfibrozil or rifampin, due to drug interactions with pioglitazone.
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active liver disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
New York University
New York, New York, 10016
About this study
Official title: Pilot Trial of Pioglitazone in Adults Undergoing Surgical Resection of Non-Small Cell Lung Cancer
Background:
- Pioglitazone is a drug that belongs to the class of antidiabetic agents called thiazolidinediones. It is approved for treatment of type 2 diabetes mellitus.
- Research suggests that the thiazolidinediones may have anticancer activity that can reduce cancer risk or cause tumors to shrink.
Read more
Objectives:
-To test how a pioglitazone works as a treatment of Stage IA to IIB Non-Small Cell Lung Cancer (NSCLC) and to look at the effect of the drug on cancer cells.
Eligibility:
-Patients 18 years of age or older who will undergo surgery for Stage IA to IIB non-small cell lung cancer (NSCLC).
Design:
-The study includes a screening visit to determine eligibility, treatment with pioglitazone, a follow-up visit after 2 to 3 weeks of treatment and a post-surgery visit. Procedures include:
- Medical history, physical examination, blood tests, electrocardiogram
- Bronchoscopy to obtain cancer cells. This is done before pioglitazone treatment begins and again during lung surgery. Some patients may also require mediastinoscopy or biopsy to collect cells.
- Treatment with pioglitazone tablets once a day for at least 2 weeks and no more than 6 weeks, depending on when surgery has been scheduled.
- Positron emission tomography (PET) scan before starting pioglitazone treatment. National Cancer Institute (NCI) patients also have a follow-up PET scan after treatment but before surgery.
Read the detailed description
Background:
Lung cancer is the leading cause of cancer deaths in the United States (US). Chemoprevention is an active area of investigation for reducing the burden of this disease. However, the choice of chemopreventive targets requires sufficient human data to justify extensive clinical interventions.
Peroxisome proliferator-activated receptor gamma (PPAR gamma) is a ligand activated nuclear transcription factor that is a key regulator of adipogenic differentiation. PPAR gamma ligands, particularly the thiazolidinedione class of antidiabetic agents exemplified by pioglitazone, are under investigation as chemopreventive agents.
PPAR gamma is expressed in normal lung and in NSCLC. PPAR gamma ligands induce apoptosis in NSCLC cell lines and modulate their differentiation status. Animal carcinogenesis studies, however, show equivocal efficacy in prevention of lung cancer.
Relevant human data are limited to an epidemiologic study showing that lung cancer risk is decreased in diabetics taking thiazolidinediones and a small phase IIa trial of pioglitazone in oral leukoplakia showing an 80% clinical response (partial response (PR)+ complete response (CR)). Further data are needed prior to engaging in a phase II lung chemoprevention trial.
Objectives:
The objectives of this pilot feasibility study are to evaluate the effect of pioglitazone on the expression of multiple biomarkers in NSCLC tumor tissue and in histologically normal and premalignant tissue.
- The primary endpoint will be the effect of pioglitazone on Ki-67, a marker of proliferation, in tumor tissue.
- The secondary objectives are to determine the effects of pioglitazone on multiple biomarkers in tumor, premalignant, and histologically normal bronchial epithelium and in serum:
- Tumor tissue biomarkers: apoptotic index (AI), cyclin D1, p21/Waf1, PPAR gamma, mucin 1 (MUC1), gelsolin, proline oxidase, 15-hydroxyprostaglandin dehydrogenase (15-PGDH)
- Premalignant tissue biomarkers: Ki-67, apoptotic index, PPAR gamma
- Histologically normal tissue biomarkers: Ki-67, PPAR gamma
- Serum markers affected by pioglitazone; C-reactive protein, CA 15-3
- Serum tumor markers: carcinoembryonic antigen (CEA), cancer antigen 125 (CA-125)
- Additional secondary objectives are:
- To evaluate the toxicity and safety of pioglitazone in this patient population,
- To determine if limited treatment with pioglitazone affects tumor metabolic activity as determined by fludeoxyglucose positron-emission tomography (FDG-PET).
Eligibility:
Adult patients with newly diagnosed histologically confirmed stage Ia-IIb resectable non-small cell lung cancer who are eligible for and scheduled to undergo definitive surgery.
Eastern Cooperative Oncology Group (ECOG) 0-2
Normal organ function
Design:
Open label, multi-center, non-randomized pilot study to evaluate the effect of pioglitazone on the expression of multiple biomarkers in NSCLC tumor tissue and in histologically normal and premalignant tissue obtained from treatment-naive individuals who will receive oral pioglitazone prior to definitive surgery. The primary endpoint is Ki-67 measured in tumor tissue.
Patients will receive pioglitazone 45 mg po qd for a minimum of 2 weeks or a maximum of 6 weeks, with duration of treatment determined by standard of care and scheduling of surgery.
The study will consist of a screening visit, baseline bronchoscopy with tissue acquisition, pioglitazone treatment for 2-6 weeks, a 2-week on-treatment clinic visit, definitive surgical resection with bronchoscopy performed at the time of resection, and a post-surgery visit. Tissue (visually normal and abnormal areas identified during bronchoscopy) and tumor will be obtained at baseline and at the time of surgery. Patients who receive their treatment at NCI will also undergo a follow up FDG-PET scan after a minimum of 2 weeks of pioglitazone treatment.
Up to 25 patients are expected to be enrolled to identify 20 patients with adequate tissue for biomarker analysis.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Pioglitazone
- Keywords
- NSCLC Stage Ia-IIb, Resectable NSCLC, Non-Small Cell Lung Cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
45 mg tablet daily by mouth for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | 45 mg tablet daily by mouth for six weeks Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Change in Ki-67 Due to the Effect of Pioglitazone in Tumor Tissue
Antigen ki-67 (Ki-67) will be assessed by immunohistochemistry.
Measured: 58 days
Secondary outcomes (6)
Number of Participants With Effects of Pioglitazone on Multiple Biomarkers in Tumor
Apoptotic index (A1) will be assessed by terminal deoxynucleotidyl transferase dUTP end labeling (TUNEL) and cyclin D1, p21/Waf1, PPARy, MUC1, gelsolin, proline oxidase, and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) will be assessed by immunohistochemistry.
Measured: 58 days
Number of Participants With Adverse Events
Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.
Measured: 58 days
Number of Participants With Metabolic Activity Determined by Fludeoxyglucose Positron-emission Tomography (FDG-PET)
Response will be evaluated by FDG-PET. Response is defined as a decrease of standardized uptake values (SUV) of more than one.
Measured: 58 days
Number of Participants With Effects of Pioglitazone on Premalignant Tissue Biomarkers
Premalignant tissue biomarkers ki-67, apoptotic index and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.
Measured: 58 days
Number of Participants With Effects of Pioglitazone on Histologically Normal Tissue Biomarkers
ki-67 and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.
Measured: 58 days
Number of Participants With Effects of Pioglitazone on Serum Tumor Markers
C-reactive protein, cancer antigen 15-3 (CA 15-3), cancer antigen 125 (CA-125) and carcinoembryonic antigen (CEA) will be assessed by immunohistochemistry.
Measured: 58 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Study never published; terminated early due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Giuseppe Giaccone, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923949
- Sponsor's protocol ID
- 080208
- Other IDs
- 08-C-0208
- Status last verified
- Feb 2012
- First submitted
- 17 Jun 2009
- Last updated
- 30 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43.
PubMed 17237035Elstner E, Muller C, Koshizuka K, Williamson EA, Park D, Asou H, Shintaku P, Said JW, Heber D, Koeffler HP. Ligands for peroxisome proliferator-activated receptorgamma and retinoic acid receptor inhibit growth and induce apoptosis of human breast cancer cells in vitro and in BNX mice. Proc Natl Acad Sci U S A. 1998 Jul 21;95(15):8806-11. doi: 10.1073/pnas.95.15.8806.
PubMed 9671760Sarraf P, Mueller E, Jones D, King FJ, DeAngelo DJ, Partridge JB, Holden SA, Chen LB, Singer S, Fletcher C, Spiegelman BM. Differentiation and reversal of malignant changes in colon cancer through PPARgamma. Nat Med. 1998 Sep;4(9):1046-52. doi: 10.1038/2030.
PubMed 9734398
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Pioglitazone in Adults Undergoing Surgical Resection of Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00923949
- Acronym / sponsor ID
- 080208
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- NSCLC Stage Ia-IIb, Resectable NSCLC, Non-Small Cell Lung Cancer, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study never published; terminated early due to low accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Posted 14 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Pioglitazone is a drug that belongs to the class of antidiabetic agents called thiazolidinediones. It is approved for treatment of type 2 diabetes mellitus.
- Research suggests that the thiazolidinediones may have anticancer activity that can reduce cancer risk or cause tumors to shrink.
Objectives:
-To test how a pioglitazone works as a treatment of Stage IA to IIB Non-Small Cell Lung Cancer (NSCLC) and to look at the effect of the drug on cancer cells.
Eligibility:
-Patients 18 years of age or older who will undergo surgery for Stage IA to IIB non-small cell lung cancer (NSCLC).
Design:
-The study includes a screening visit to determine eligibility, treatment with pioglitazone, a follow-up visit after 2 to 3 weeks of treatment and a post-surgery visit. Procedures include:
- Medical history, physical examination, blood tests, electrocardiogram
- Bronchoscopy to obtain cancer cells. This is done before pioglitazone treatment begins and again during lung surgery. Some patients may also require mediastinoscopy or biopsy to collect cells.
- Treatment with pioglitazone tablets once a day for at least 2 weeks and no more than 6 weeks, depending on when surgery has been scheduled.
- Positron emission tomography (PET) scan before starting pioglitazone treatment. National Cancer Institute (NCI) patients also have a follow-up PET scan after treatment but before surgery.
Detailed description
Background:
Lung cancer is the leading cause of cancer deaths in the United States (US). Chemoprevention is an active area of investigation for reducing the burden of this disease. However, the choice of chemopreventive targets requires sufficient human data to justify extensive clinical interventions.
Peroxisome proliferator-activated receptor gamma (PPAR gamma) is a ligand activated nuclear transcription factor that is a key regulator of adipogenic differentiation. PPAR gamma ligands, particularly the thiazolidinedione class of antidiabetic agents exemplified by pioglitazone, are under investigation as chemopreventive agents.
PPAR gamma is expressed in normal lung and in NSCLC. PPAR gamma ligands induce apoptosis in NSCLC cell lines and modulate their differentiation status. Animal carcinogenesis studies, however, show equivocal efficacy in prevention of lung cancer.
Relevant human data are limited to an epidemiologic study showing that lung cancer risk is decreased in diabetics taking thiazolidinediones and a small phase IIa trial of pioglitazone in oral leukoplakia showing an 80% clinical response (partial response (PR)+ complete response (CR)). Further data are needed prior to engaging in a phase II lung chemoprevention trial.
Objectives:
The objectives of this pilot feasibility study are to evaluate the effect of pioglitazone on the expression of multiple biomarkers in NSCLC tumor tissue and in histologically normal and premalignant tissue.
- The primary endpoint will be the effect of pioglitazone on Ki-67, a marker of proliferation, in tumor tissue.
- The secondary objectives are to determine the effects of pioglitazone on multiple biomarkers in tumor, premalignant, and histologically normal bronchial epithelium and in serum:
- Tumor tissue biomarkers: apoptotic index (AI), cyclin D1, p21/Waf1, PPAR gamma, mucin 1 (MUC1), gelsolin, proline oxidase, 15-hydroxyprostaglandin dehydrogenase (15-PGDH)
- Premalignant tissue biomarkers: Ki-67, apoptotic index, PPAR gamma
- Histologically normal tissue biomarkers: Ki-67, PPAR gamma
- Serum markers affected by pioglitazone; C-reactive protein, CA 15-3
- Serum tumor markers: carcinoembryonic antigen (CEA), cancer antigen 125 (CA-125)
- Additional secondary objectives are:
- To evaluate the toxicity and safety of pioglitazone in this patient population,
- To determine if limited treatment with pioglitazone affects tumor metabolic activity as determined by fludeoxyglucose positron-emission tomography (FDG-PET).
Eligibility:
Adult patients with newly diagnosed histologically confirmed stage Ia-IIb resectable non-small cell lung cancer who are eligible for and scheduled to undergo definitive surgery.
Eastern Cooperative Oncology Group (ECOG) 0-2
Normal organ function
Design:
Open label, multi-center, non-randomized pilot study to evaluate the effect of pioglitazone on the expression of multiple biomarkers in NSCLC tumor tissue and in histologically normal and premalignant tissue obtained from treatment-naive individuals who will receive oral pioglitazone prior to definitive surgery. The primary endpoint is Ki-67 measured in tumor tissue.
Patients will receive pioglitazone 45 mg po qd for a minimum of 2 weeks or a maximum of 6 weeks, with duration of treatment determined by standard of care and scheduling of surgery.
The study will consist of a screening visit, baseline bronchoscopy with tissue acquisition, pioglitazone treatment for 2-6 weeks, a 2-week on-treatment clinic visit, definitive surgical resection with bronchoscopy performed at the time of resection, and a post-surgery visit. Tissue (visually normal and abnormal areas identified during bronchoscopy) and tumor will be obtained at baseline and at the time of surgery. Patients who receive their treatment at NCI will also undergo a follow up FDG-PET scan after a minimum of 2 weeks of pioglitazone treatment.
Up to 25 patients are expected to be enrolled to identify 20 patients with adequate tissue for biomarker analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: Pioglitazone45 mg tablet daily by mouth for six weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- absolute neutrophil count greater than or equal to 1,500/mL
- hemoglobin greater than 10 g/dL
- platelets greater than or equal to 100,000/mL
- Bilirubin less than 1.8 mg/dL
- aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 1.5 times upper limits of institutional normal
Key exclusion criteria (7 listed)
- Pregnant or lactating women.
- Patients who are undergoing chemotherapy, treatment with biologic agents, or radiation therapy. Prior chemotherapy, biologic agent treatment, or radiation therapy, greater than 1 year ago, is allowed.
- Patients with greater than or equal to class II New York Heart Association (NYHA) congestive heart failure or history of congestive heart failure.
- Patients with greater than or equal to grade 2 (moderate) edema.
- Patients with diabetes mellitus being treated with insulin or any pharmacologic therapy.
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 |
|---|---|---|
| Pioglitazone45 mg tablet daily by mouth for six weeks | Drug | Pioglitazone |
Primary outcome
Number of Participants With a Change in Ki-67 Due to the Effect of Pioglitazone in Tumor Tissue
Time frame: 58 days
Antigen ki-67 (Ki-67) will be assessed by immunohistochemistry.
6 secondary outcomes
Number of Participants With Effects of Pioglitazone on Multiple Biomarkers in Tumor
Time frame: 58 days
Number of Participants With Adverse Events
Time frame: 58 days
Number of Participants With Metabolic Activity Determined by Fludeoxyglucose Positron-emission Tomography (FDG-PET)
Time frame: 58 days
Number of Participants With Effects of Pioglitazone on Premalignant Tissue Biomarkers
Time frame: 58 days
Number of Participants With Effects of Pioglitazone on Histologically Normal Tissue Biomarkers
Time frame: 58 days
Number of Participants With Effects of Pioglitazone on Serum Tumor Markers
Time frame: 58 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17237035Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43.
- Background: PubMed 9671760Elstner E, Muller C, Koshizuka K, Williamson EA, Park D, Asou H, Shintaku P, Said JW, Heber D, Koeffler HP. Ligands for peroxisome proliferator-activated receptorgamma and retinoic acid receptor inhibit growth and induce apoptosis of human breast cancer cells in vitro and in BNX mice. Proc Natl Acad Sci U S A. 1998 Jul 21;95(15):8806-11. doi: 10.1073/pnas.95.15.8806.
- Background: PubMed 9734398Sarraf P, Mueller E, Jones D, King FJ, DeAngelo DJ, Partridge JB, Holden SA, Chen LB, Singer S, Fletcher C, Spiegelman BM. Differentiation and reversal of malignant changes in colon cancer through PPARgamma. Nat Med. 1998 Sep;4(9):1046-52. doi: 10.1038/2030.
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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.
Giuseppe Giaccone, M.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pioglitazone in people with Non-Small-Cell Lung Cancer, run by National Cancer Institute (NCI) 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 18 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Sep 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Change in Ki-67 Due to the Effect of Pioglitazone in Tumor Tissue (time frame: 58 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00923949, which also lists 3 linked publications.
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 Sep 2015.