Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
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.