Napo Therapeutics NP303-102

Official Title

On Target: 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 Regimens

Study Purpose

To evaluate the safety and efficacy of orally administered crofelemer for prophylaxis of diarrhea in adult patients with solid tumors received targeted cancer therapies with or without standard chemotherapy regimens for their solid tumors.

Diagnosis

Patients who have been prescribed a certain type of targeted cancer therapy and/or chemotherapy drugs for the treatment of their cancer.

Eligibility

Solid tumors that will be treated with a targeted therapy with a high rate of diarrhea incidence

Immunotherapy treatments are not eligible.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

Patients will be randomly selected for one of the study groups:

Group 1: Patients will receive the study drug, crofelemer for 12 weeks with option to extend to 24 weeks.

Group 2: Patients will receive a placebo for 12 weeks with option to extend to 24 weeks.