Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy
Public ClinicalTrials.gov record NCT04538625. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04538625
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 287 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 7, 2020 (Actual)
- Primary completion
- Aug 7, 2023 (Actual)
- Completion
- Oct 30, 2023 (Actual)
- Last update posted
- Jul 26, 2024
2020 – 2023
United States locations
- U.S. sites
- 27
- U.S. states
- 14
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates PC - HAL | Prescott | Arizona | 86314 | — |
| Pacific Cancer Medical Center Inc | Anaheim | California | 92801 | — |
| The Oncology Institute of Hope and Innovation | Corona | California | 92882 | — |
| The Oncology Institute of Hope and Innovation | Glendale | California | 91204 | — |
| PIH Health Whittier Hospital | Whittier | California | 90602 | — |
| SCL Health Research Institute | Lafayette | Colorado | 80218 | — |
| GenesisCare USA | Aventura | Florida | 33180 | — |
| Cancer Care Centers of Brevard, Inc. | Palm Bay | Florida | 32909 | — |
| BRCR Global | Plantation | Florida | 33322 | — |
| Advanced Research Institute | St. Petersburg | Florida | 33710 | — |
| American Oncology Partners of Maryland | Bethesda | Maryland | 20817 | — |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| North Shore Hematology Oncology Associates dba New York Cancer and Blood Specialists | Port Jefferson Station | New York | 11776 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Gabrail Cancer Research | Canton | Ohio | 44718 | — |
| Oregon Health & Science University (OHSU) Knight Cancer Institute | Portland | Oregon | 97239 | — |
| The West Clinic Research | Germantown | Tennessee | 38138 | — |
| Texas Oncology - Denison | Denison | Texas | 75020 | — |
| Texas Oncology, P.A. - Flower Mound | Flower Mound | Texas | 75028 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Texas Oncology - New Braunfels | New Braunfels | Texas | 78130 | — |
| Texas Oncology - Plano East | Plano | Texas | 75075-7787 | — |
| Texas Oncology - Gulf Coast | Webster | Texas | 77598 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| Shenandoah Oncology Associates | Winchester | Virginia | 22601 | — |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04538625, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04538625 live on ClinicalTrials.gov.