A Phase 2 interventional study of pioglitazone hydrochloride in Head and Neck Cancer and Oral Leukoplakia, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Prevention
Among 20 studies in Leukoplakia, Oral with a site in United States — 1 open to participants now, 3 under way, none of them phase 3. Leukoplakia, Oral · United States.
Among the 20 studies in Leukoplakia, Oral with a site in United States, this one is the 10th largest by enrollment of the 15 interventional ones that give a count, is one of 4 that started in 2003, is one of 11 in phase 2, and was the 3rd registered.
48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.
Browse Leukoplakia, Oral studies →1 of the 20 studies in Leukoplakia, Oral with a site in United States is open now. Recruiting first, the newest first:
University of Minnesota · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 7 Leukoplakia, Oral studies recruiting now, 5 set no upper age limit and none stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 4 started in 2003.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 21 is below the median of 36 across 23 interventional studies indexed under Leukoplakia, Oral.
Median enrollment 26 across the 15 interventional studies, 487 across the 2 observational. Of the 15 that completed or were terminated, 6 (40%) have results posted.
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4 of 20 have an industry lead sponsor. The 10 most frequent:
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
National Cancer Institute (NCI) has 7 studies filed under Leukoplakia, Oral — fewer than ten, so there is no comparison to draw.
1 of the studies in Leukoplakia, Oral with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05727761University of MinnesotaPioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia | 2027-07-30 |
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Among the 20 studies in Leukoplakia, Oral with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This phase II trial studies how well pioglitazone hydrochloride works in preventing head and neck cancer in patients who have oral leukoplakia. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of pioglitazone hydrochloride may be effective in preventing head and neck cancer.
PRIMARY OBJECTIVES:
I. Determine whether pioglitazone (pioglitazone hydrochloride) reverses leukoplakia in patients with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia.
SECONDARY OBJECTIVES:
I. Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) for 12 weeks in the absence of disease progression, unacceptable toxicity, or the development of carcinoma.
Patients are followed up at 4, 8, 12, and 16 weeks.
48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.
This study's enrollment of 21 is below the median of 36 across 23 interventional studies indexed under Leukoplakia, Oral.
Browse Leukoplakia, Oral studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
Compared within Leukoplakia, Oral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Head and Neck Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive pioglitazone hydrochloride PO QD for 12 weeks in the absence of disease progression, unacceptable toxicity, or the development of carcinoma.
Drug: pioglitazone hydrochloride
Given PO
Also known as: Actos, pioglitazone
Patients' Overall Response
Overall Response= reviewing both the clinical and histological responses and assigning the worst category. Complete Response (CR) = Clinical CR and Histologic CR, or Histologic CR Partial Response (PR) = Clinical CR or PR and Histologic PR or Stable Disease (SD) Stable Disease (SD) = Clinical SD and Histologic PR or SD Progressive Disease (PD) = Clinical PD and/or Histologic PD
Time frame: Week 16 (4 weeks post dose)
Patients' Clinical Response
Determined by measurement of lesions- Complete Response (CR)= disappearance of all lesions, Partial Response (PR)= \>or= 50% decrease in sum of lesions, Stable Disease (SD) = does not meet CR,PR or Progressive Disease (PD), and PD= \>or= 25% increase in sum of lesions
Time frame: Week 16 (4 weeks post dose)
Patients' Histological (Tissue) Response
Determined by biopsy results before and 4 weeks after treatment: Complete Response (CR) =complete reversal of dysplasia or hyperplasia, Partial Response (PR) = \>or=50% decrease in sum of lesions, no increase in 1 or more lesions and no new lesion occurs, Stable Disease (SD0 = not CR, PR or Progressive Disease (PD), PD = \>or= 25% increase in sum of lesions or new lesion or progression to invasive carcinoma.
Time frame: Week 16 (4 weeks post dose)
Interleukin 6, 8 and Vascular Endothelial Growth Factors Elaboration in the Oral Cavity and Serum
Quantitative studies of serum and saliva components for a pre and post treatment possible biomarker.
Time frame: Pre (Day 0) and Post (Week 12) Treatment
Quantitative Oil Red O, AP2 (FABP4) and FABP5 Staining
Immune histochemistry / tissue staining for a possible biomarker.
Time frame: Pre (Day 0) and Post (Week 12) Treatment
Involucrin and Transglutaminase Staining
Immune histochemistry / tissue staining for a possible biomarker.
Time frame: Pre (Day 0) and Post (Week 12) Treatment
Cyclin D1 and p21 Immune Histochemistry
Immune histochemistry / tissue staining for a possible biomarker.
Time frame: Pre (Day 0) and Post (Week 12) Treatment
Cyclooxygenase-2 Staining
Immune histochemistry / tissue staining for a possible biomarker.
Time frame: Pre (Day 0) and Post (Week 12) Treatment
Piogliotazone Gamma Immune Histochemistry
Immune histochemistry / tissue staining for a possible biomarker.
Time frame: Pre (Day 0) and Post (Week 12) Treatment
Ki 67 Labeling Index
Immune histochemistry / tissue staining for a possible biomarker.
Time frame: Pre (Day 0) and Post (Week 12) Treatment
Apotosis (Cell Death)
Immune histochemistry / tissue staining for a possible biomarker.
Time frame: Pre (Day 0) and Post (Week 12) Treatment
Nf Kappa B p65
Immune histochemistry / tissue staining for a possible biomarker.
Time frame: Pre (Day 0) and Post (Week 12) Treatment
| Milestone | Pioglitazone Patients |
|---|---|
| Started | 21 |
| Completed | 21 |
| Not completed | 0 |
Overall Response= reviewing both the clinical and histological responses and assigning the worst category. Complete Response (CR) = Clinical CR and Histologic CR, or Histologic CR Partial Response (PR) = Clinical CR or PR and Histologic PR or Stable Disease (SD) Stable Disease (SD) = Clinical SD and Histologic PR or SD Progressive Disease (PD) = Clinical PD and/or Histologic PD
| Participants | Pioglitazone Patients |
|---|---|
| Complete Response | 0 |
| Partial Response | 15 |
| Stable Disease | 2 |
| Progressive Disease | 4 |
| Partial + Complete Response | 15 |
Determined by measurement of lesions- Complete Response (CR)= disappearance of all lesions, Partial Response (PR)= \>or= 50% decrease in sum of lesions, Stable Disease (SD) = does not meet CR,PR or Progressive Disease (PD), and PD= \>or= 25% increase in sum of lesions
| Participants | Pioglitazone Patients |
|---|---|
| Complete Response | 3 |
| Partial Response | 14 |
| Stable Disease | 4 |
| Progressive Disease | 0 |
| Partial + Complete | 17 |
Determined by biopsy results before and 4 weeks after treatment: Complete Response (CR) =complete reversal of dysplasia or hyperplasia, Partial Response (PR) = \>or=50% decrease in sum of lesions, no increase in 1 or more lesions and no new lesion occurs, Stable Disease (SD0 = not CR, PR or Progressive Disease (PD), PD = \>or= 25% increase in sum of lesions or new lesion or progression to invasive carcinoma.
| Participants | Pioglitazone Patients |
|---|---|
| Complete Response | 1 |
| Partial Response | 2 |
| Stable Disease | 14 |
| Progressive Disease | 4 |
| Partial + Complete Response | 3 |
Quantitative studies of serum and saliva components for a pre and post treatment possible biomarker.
Results for this outcome have not been posted.
Immune histochemistry / tissue staining for a possible biomarker.
Results for this outcome have not been posted.
Immune histochemistry / tissue staining for a possible biomarker.
Results for this outcome have not been posted.
Immune histochemistry / tissue staining for a possible biomarker.
Results for this outcome have not been posted.
Immune histochemistry / tissue staining for a possible biomarker.
Results for this outcome have not been posted.
Immune histochemistry / tissue staining for a possible biomarker.
Results for this outcome have not been posted.
Immune histochemistry / tissue staining for a possible biomarker.
Results for this outcome have not been posted.
Immune histochemistry / tissue staining for a possible biomarker.
Results for this outcome have not been posted.
Immune histochemistry / tissue staining for a possible biomarker.
Results for this outcome have not been posted.
Collected over From first dose of Pioglitazone through Week 16 (end of study).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pioglitazone Patients | — | 0/21 (0%) | 18/21 (85.7%) |
| Event | Pioglitazone Patients |
|---|---|
| Peripheral edemaBlood and lymphatic system disorders | 6/21 |
| HeadacheGeneral disorders | 5/21 |
| Joint painMusculoskeletal and connective tissue disorders | 4/21 |
| NauseaGastrointestinal disorders | 4/21 |
| Upper respiratory infectionInfections and infestations | 4/21 |
| DiarrheaGastrointestinal disorders | 3/21 |
| FatigueGeneral disorders | 3/21 |
| Lightheadness, dizzyNervous system disorders | 3/21 |
| Muscle stiffness, aches, myalgiaMusculoskeletal and connective tissue disorders | 3/21 |
| Back painMusculoskeletal and connective tissue disorders | 2/21 |
| Age, Categorical(Participants) | Pioglitazone Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 2 |
| Age, Continuous(years) | Pioglitazone Patients |
|---|---|
| Median | 56.1 (27 to 75) |
| Sex: Female, Male(Participants) | Pioglitazone Patients |
|---|---|
| Female | 12 |
| Male | 9 |
| Region of Enrollment(participants) | Pioglitazone Patients |
|---|---|
| United States | 21 |
The record gives a start of Jun 2003, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2009, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pioglitazone
National Cancer Institute (NCI) →