Sulindac: Clinical Trials

27 trials of Sulindac, newest first

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15 completed, 5 terminated, 4 withdrawn, 2 active not recruiting. 17 Phase 2, 4 Not applicable, 4 Phase 3, 2 Phase 1.

By phase and status

PhaseTrialsStatus
Phase 217Completed 9, Terminated 3, Withdrawn 3, Active not recruiting 1, Unknown 1
Not applicable4Completed 2, Terminated 2
Phase 34Completed 2, Active not recruiting 1, Withdrawn 1
Phase 12Completed 2

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40
Sulindac (HLX-0201), dose strength 1, Sulindac (HLX-0201), dose strength 2, Placebo - Fragile X Syndrome
Phase 2WithdrawnHealx Limited2022-05-252022-12-08
Sulindac and Breast Density in Women at Risk of Developing Breast Cancer
Sulindac Pill, Placebo - Breast Cancer
Phase 2CompletedAlison Stopeck612020-11-202026-07-17
The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)
Sulindac 400 MG, Placebo - IPMN, IPMN, Pancreatic
Phase 2Active not recruitingDuke University1002020-07-102026-09-08
Urinary Biomarker Study With Sulindac and Difluoromethylornithine
difluoromethylornithine, Sulindac - Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms
Phase 2WithdrawnCancer Prevention Pharmaceuticals, Inc.2014-03-012014-07-30
Sulindac for Patients With AML
Cytarabine, Sulindac - Acute Myeloid Leukemia
Phase 2WithdrawnMassachusetts General Hospital2014-01-012017-02-17
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)
Eflornithine, Eflornithine Placebo, Sulindac 150 MG - Familial Adenomatous Polyposis
Phase 3CompletedCancer Prevention Pharmaceuticals, Inc.1712013-10-012021-06-08
S0820, Adenoma and Second Primary Prevention Trial
Eflornithine placebo & sulindac placebo, eflornithine & sulindac placebo, Eflornithine placebo & sulindac - Colorectal Neoplasms
Phase 3Active not recruitingSWOG Cancer Research Network3542013-08-232026-10-23
Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer
Sulindac, Placebo, Validate assays and shipping methods - Colorectal Cancer, Liver Metastasis
Phase 2TerminatedNational Cancer Institute (NCI)32013-04-012015-10-23
NSAID Effects on Clinical and Imaging Breast Biomarkers
Sulindac - Inflammation, Cancer
Phase 2CompletedStony Brook University1142012-12-012023-02-10
A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)
Eflornithine plus Sulindac, Eflornithine plus Placebo, Sulindac plus Placebo - Familial Adenomatous Polyposis
Phase 3WithdrawnCancer Prevention Pharmaceuticals, Inc.2011-03-012015-04-24
A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients
Erlotinib, Sulindac, Placebo A - Adenomatous Polyposis Coli
Phase 2CompletedUniversity of Utah922010-04-012016-06-17
Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma
sulindac, placebo, laboratory biomarker analysis - Precancerous Condition
Phase 2CompletedNational Cancer Institute (NCI)502009-02-012017-12-26
Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma
epirubicin hydrochloride, sulindac, immunologic technique - Melanoma (Skin)
Phase 2CompletedCancer Trials Ireland322007-08-012014-12-31
Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck
Bevacizumab, erlotinib, Sulindac - Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Phase 2TerminatedMassachusetts General Hospital362006-10-012017-04-13
Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
sulindac, placebo - Precancerous Condition, Stage I Non-small Cell Lung Cancer
Phase 2CompletedNational Cancer Institute (NCI)612006-08-012014-05-23
Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
Sulindac (drug), VSL#3 (probiotic), Inulin (probiotic) - Adenomatous Polyposis Coli
Phase 2UnknownRadboud University Medical Center302006-04-012007-08-10
Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers
sulindac, pharmacological study - Unspecified Adult Solid Tumor, Protocol Specific
Not applicableCompletedMayo Clinic282006-04-012015-04-28
Atorvastatin Calcium, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia
oligofructose-enriched inulin, sulindac, placebo - Colon Cancer, Precancerous Condition
Phase 2CompletedNational Cancer Institute (NCI)852006-03-012017-02-15
A Randomized Study of Sulindac in Oral Premalignant Lesions
sulindac, Placebo - Leukoplakia, Oral, Benign Neoplasms
Not applicableCompletedMemorial Sloan Kettering Cancer Center632006-02-232020-11-19
Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer
sulindac, laboratory biomarker analysis - Breast Cancer
Phase 1CompletedNational Cancer Institute (NCI)302005-11-012013-05-03

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Conditions studied

Adenomatous Polyposis Coli (4)  ·  Breast Neoplasms (4)  ·  Colorectal Neoplasms (4)  ·  Precancerous Conditions (4)  ·  Colonic Neoplasms (3)  ·  Neoplasms (3)  ·  Squamous Cell Carcinoma of Head and Neck (2)  ·  Aberrant Crypt Foci (1)  ·  Breast Carcinoma In Situ (1)  ·  Carcinoma, Intraductal, Noninfiltrating (1)  ·  Carcinoma, Non-Small-Cell Lung (1)  ·  Colonic Polyps (1)  ·  Coproporphyria (1)  ·  Desmoid Tumors (1)  ·  Fragile X Syndrome (1)

Sponsors

National Cancer Institute (NCI) (6)  ·  Cancer Prevention Pharmaceuticals, Inc. (3)  ·  Massachusetts General Hospital (2)  ·  University of Medicine and Dentistry of New Jersey (2)  ·  Alison Stopeck (1)  ·  Cancer Trials Ireland (1)  ·  Children's Oncology Group (1)  ·  Duke University (1)  ·  Fox Chase Cancer Center (1)  ·  Healx Limited (1)  ·  M.D. Anderson Cancer Center (1)  ·  Mayo Clinic (1)  ·  Memorial Sloan Kettering Cancer Center (1)  ·  Radboud University Medical Center (1)  ·  SWOG Cancer Research Network (1)

Countries

United States (23)  ·  Canada (2)  ·  Netherlands (2)  ·  Australia (1)  ·  Belgium (1)  ·  Germany (1)  ·  India (1)  ·  Ireland (1)  ·  Spain (1)  ·  United Kingdom (1)

Top investigators

Alfred M. Cohen, M.D. (1)  ·  Alison S Stopeck, MD (1)  ·  Alison Stopeck, MD (1)  ·  Amir Fathi, MD (1)  ·  Carol Burke, M.D. (1)  ·  Elizabeth Berry-Kravis (1)  ·  Fokko M Nagengast, PhD (1)  ·  Frank Meyskens (1)  ·  James Church, M.D. (1)  ·  James Jett (1)  ·  Jason A. Zell, D.O., MPH (1)  ·  Jay O. Boyle, M.D. (1)  ·  Jennifer Grandis, MD (1)

Results publications

PMID 20538001, PMID 23261228, PMID 27002448, PMID 29423501, PMID 30012100, PMID 32905675, PMID 34112707, PMID 34261858, PMID 35039952

NIH funding

N01CN35000 (2), P30CA015083 (2), P30CA023074 (2), N01CN35158 (1), P01CA073992 (1), P30CA006927 (1), P30CA016056 (1), P30CA016672 (1), R01CA088078 (1), R01CA235677 (1), U10CA037429 (1), U10CA098543 (1)