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Anti-Diarrheal Agent

Crofelemer for Preventing Diarrhea in Cancer Patients (OnTARGET Trial)

Phase 3
Waitlist Available
Led By Pablo Okhuysen, MD
Research Sponsored by Napo Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
You are 18 years of age or older.
You have received one of the following organ transplants (i.e.liver, or lung) at least 6 months ago.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial 12-week (stage 1) period of the study.
Awards & highlights
Pivotal Trial

Summary

This trial is a 24-week study of crofelemer to see if it is safe and effective in preventing diarrhea in adult patients with solid tumors being treated with targeted cancer therapy.

Who is the study for?
Adults over 18 with solid tumors eligible for targeted cancer therapy as per NCCN guidelines can join this trial. They must have a life expectancy to survive at least 12 weeks of treatment, an ECOG status of 0-2, and be scheduled for drugs known to cause diarrhea in half the cases. Pregnant women and those with certain bowel conditions or infections cannot participate.
What is being tested?
The study tests if crofelemer can prevent diarrhea in patients undergoing targeted cancer therapies compared to a placebo. It's a double-blind trial where neither doctors nor patients know who gets the real drug or placebo during two stages lasting a total of 24 weeks.
What are the potential side effects?
While specific side effects are not listed here, crofelemer is generally considered safe but may include symptoms like gas, stomach pain, headaches, coughing or back pain based on its use for other conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial 12-week (stage 1) period of the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and initial 12-week (stage 1) period of the study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of Number of Loose/watery Stools
Secondary study objectives
Fecal Incontinence
Maximum Number of Weekly Loose/Watery Stools
Proportion of Durable, Clinical Responders

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CrofelemerExperimental Treatment1 Intervention
Subjects randomized to the crofelemer arm, will receive oral doses of crofelemer 125mg delayed-release tablets twice daily with or without food.
Group II: PlaceboPlacebo Group1 Intervention
Subjects randomized to the placebo arm, will receive oral doses of matching placebo tablets twice daily with or without food.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crofelemer 125 MG [Mytesi]
2020
Completed Phase 3
~290

Find a Location

Who is running the clinical trial?

Napo Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
188 Total Patients Enrolled
3 Trials studying Diarrhea
170 Patients Enrolled for Diarrhea
Pravin Chaturvedi, PhDStudy ChairNapo Pharmaceuticals
1 Previous Clinical Trials
12 Total Patients Enrolled
Pablo Okhuysen, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Crofelemer (Anti-Diarrheal Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04538625 — Phase 3
Diarrhea Research Study Groups: Placebo, Crofelemer
Diarrhea Clinical Trial 2023: Crofelemer Highlights & Side Effects. Trial Name: NCT04538625 — Phase 3
Crofelemer (Anti-Diarrheal Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04538625 — Phase 3
~56 spots leftby Dec 2025
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