Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04538625 | Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy | PHASE3 | COMPLETED | 287 | — | — | Oct 7, 2020 | Oct 30, 2023 | Jul 26, 2024 | 52 | United States, Argentina +3 |
The frequency of diarrhea as measured by the average number of loose/watery stools per week will be evaluated as a continuous endpoint.
| 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. |
| Name | Type | Description |
|---|---|---|
| Crofelemer 125 MG [Mytesi] | DRUG | Randomized, Double-blind, Placebo-controlled, two arm trial |
| Placebo | DRUG | Matching placebo tablets |
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...