Symptoms and General Pathology

All Conditions

Diarrhea

Signs and Symptoms, Digestive

Subjects randomized to the placebo arm, will receive oral doses of matching placebo tablets twice daily with or without food.

Subjects randomized to the crofelemer arm, will receive oral doses of crofelemer 125mg delayed-release tablets twice daily with or without food.

Randomized, Double-blind, Placebo-controlled, two arm trial

Crofelemer 125 MG [Mytesi]

Placebo

Pablo Okhuysen, MD

Pravin Chaturvedi, PhD

A 24-week, (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens. Diarrhea grading will be done according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Patients will be randomized 1:1 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type. Placebo and/or crofelemer will be dispensed at Visit 1/Day 1 with the concurrent start of the targeted cancer therapy regimen. The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles. The Primary and Secondary Endpoints will be analyzed after the last patient last visit (LPLV) of Stage I.

After completing the Stage I double-blind, placebo-controlled primary treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, visit 5 will be the last study visit.

A randomized, placebo controlled, double blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors receiving targeted cancer therapy containing regimens. Diarrhea grading will be done according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE Ver. 5.0).

Randomization will be at a 1:1 ratio with subjects randomized either to crofelemer 125 mg delayed-release tablets or matching placebo tablets administered orally twice daily with or without food. Randomization will be stratified by the type of targeted cancer therapy and by tumor type. Placebo and crofelemer treatment will be initiated concomitantly with the administration of targeted cancer therapy-containing regimens.

The Stage I double-blind placebo-controlled primary treatment phase will be the first 12-week period to accommodate targeted cancer therapy with approximately three (3) cycle chemotherapy regimens (if needed) over the inclusive 12-week period after initiation of crofelemer or placebo treatment in Stage I.

After completing the Stage I treatment phase (12 weeks), and after the LPLV of the primary Stage I treatment phase, the primary and secondary endpoints will be analyzed. The subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, Visit 5 will be the last study visit. Subjects who enter into the Stage II extension phase will continue on their originally assigned study treatment commenced at the beginning of Stage I.

A randomized, placebo controlled, double blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors receiving targeted cancer therapy containing regimens. Diarrhea grading will be done according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE Ver. 5.0).

Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

A Phase 3 Multicenter, Randomized, Double-blind Placebo-controlled Trial Evaluating Crofelemer for the Prophylaxis of Diarrhea in Adult Patients With Solid Tumors Receiving Targeted-cancer Therapies With or Without Standard Chemotherapy

The frequency of diarrhea as measured by the average number of loose/watery stools per week will be evaluated as a continuous endpoint.

Proportion of "durable responders" defined as the proportion of subjects with ≤7 loose and/or watery bowel movements per week for at least 50% of the time over the Stage 1 double-blind placebo-controlled primary treatment period (Stage 1).

Maximum number of weekly unformed (loose and/or watery) bowel movements from Week 1 through end of Week 12.

Mean number of fecal incontinence episodes from Week 1 through end of Week 12

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy	NCT04538625	Cancer Therapy-... Chemotherapy-re... Adult Solid Tum... Prophylaxis of ... Symptomatic Rel... Targeted Therap...	Crofelemer 125 ... Placebo	18 Years -	Napo Pharmaceuticals, Inc.
Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy	NCT04538625	Cancer Therapy-... Chemotherapy-re... Adult Solid Tum... Prophylaxis of ... Symptomatic Rel... Targeted Therap...	Crofelemer 125 ... Placebo	18 Years -	Napo Pharmaceuticals, Inc.
Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy	NCT04538625	Cancer Therapy-... Chemotherapy-re... Adult Solid Tum... Prophylaxis of ... Symptomatic Rel... Targeted Therap...	Crofelemer 125 ... Placebo	18 Years -	Napo Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for prophylaxis of diarrhea