Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Crofelemer · 2 trials · 7 indications
The frequency of diarrhea as measured by the average number of loose/watery stools per week will be evaluated as a continuous endpoint.
Percentage of participants with any grade (based on CTCAE 4.0) diarrhea lasting 2 or more consecutive days during cycles 1 and 2 of chemotherapy.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Subjects randomized to the placebo arm, will receive oral doses of matching placebo tablets twice daily with or without food. |
| Crofelemer | EXPERIMENTAL | Subjects randomized to the crofelemer arm, will receive oral doses of crofelemer 125mg delayed-release tablets twice daily with or without food. |
| Control | NO_INTERVENTION | Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study. |
| Name | Type | Description |
|---|---|---|
| Crofelemer 125 MG [Mytesi] | DRUG | Randomized, Double-blind, Placebo-controlled, two arm trial |
| Placebo | DRUG | Matching placebo tablets |
| Crofelemer | DRUG | Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP |
Inclusion Criteria: * 1\. Patients to receive targeted cancer therapy drugs that have a reported an all grade diarrhea incidence of 50% or higher (e.g., tyrosine kinase inhibitors, cdk inhibitors, anti-EGFR, etc., for treatment of solid tumors. 2\. Patients able to provide written informed conse...