Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Rare Diseases

Adenomatous Polyposis Coli

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Amino Acids

Eflornithine

Sulindac

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Ornithine

Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]

Eflornithine placebo \[three tablets orally once a day\]

Eflornithine Placebo

Sulindac \[one tablet orally once a day\]

Sulindac 150 MG

Sulindac placebo \[one tablet orally once a day\]

Sulindac placebo

Carol Burke, M.D.

James Church, M.D.

Gabriella Möslein, M.D.

The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event. This includes: 1) FAP related disease progression indicating the need for excisional intervention involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death.

Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

Phase III Trial of the Safety and Efficacy of Eflornithine Combined With Sulindac Compared to Eflornithine, Sulindac as Single Agents in Patients With Familial Adenomatous Polyposis

Progression of disease by evaluation of FAP-related events over the course of study treatment

Global assessment of change in upper GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint.

Global assessment of change in lower GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint.

Cancer Prevention Pharmaceuticals, Inc.

Eflornithine 750 mg and Sulindac 150 mg

Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]

Sulindac 150 MG: Sulindac \[one tablet orally once a day\]

Eflornithine Plus Sulindac

Eflornithine 750 mg and Placebo

Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]

Sulindac placebo: Sulindac placebo \[one tablet orally once a day\]

Eflornithine Plus Sulindac Placebo

Sulindac 150 mg and Placebo

Eflornithine Placebo: Eflornithine placebo \[three tablets orally once a day\]

Sulindac 150 MG: Sulindac \[one tablet orally once a day\]

Sulindac Plus Eflornithine Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

Netherlands

Belgium

United States

United Kingdom

Germany

Spain

Region of Enrollment

Michelle Boytim

Intent to treat population with all FAP-related events

Number with FAP-related events

Number with Lower GI FAP-related events

Intent to treat population with 171 subjects. Intent to treat population with lower GI anatomy (ower GI population) to evaluate lower GI FAP related events with 158 subjects.

Spots Global Cancer Trial Database for Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial