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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
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.
Patients able to provide written informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial 12-week (stage 1) period of the study.
Awards & highlights

OnTARGET 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.Check my eligibility
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.See study design
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.

OnTARGET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am to be treated with cancer drugs known to frequently cause diarrhea.
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I am 18 years old or older.
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I am eligible for targeted cancer therapy as per medical guidelines.
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I can have chemotherapy and targeted therapy at the same time.
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I can care for myself and am expected to live through the next 12 weeks of therapy.
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I am not pregnant.

OnTARGET Trial 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

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

OnTARGET 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.

Find a Location

Who is running the clinical trial?

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still able to join this study?

"The website clinicaltrials.gov says that this study is still looking for volunteers. The trial was first announced on October 7th, 2020 and the most recent update was May 2nd, 2022."

Answered by AI

In how many distinct places is this trial being carried out?

"There are a total of 17 sites for this clinical trial, with the three primary locations being BRCR Global in Plantation, Florida; Inova Schar Cancer Institute in Fairfax, Virginia; and The West Clinic Research in Germantown, Tennessee."

Answered by AI

How many test subjects are included in this experiment?

"The sponsor, Napo Pharmaceuticals, Inc., needs to recruit 256 eligible patients from multiple clinical trial sites including BRCR Global in Plantation, Florida and Inova Schar Cancer Institute in Fairfax, Virginia."

Answered by AI

Does this research break new ground in the medical field?

"There are 2 ongoing trials for Crofelemer 125 MG [Mytesi], which began in 2019. Sponsored by Napo Pharmaceuticals, Inc., the first trial involved 100 patients and completed its Phase 4 drug approval stage. Since then, 18294 additional studies have been undertaken."

Answered by AI

Has the FDA given their blessing to Crofelemer 125 MG [Mytesi]?

"Crofelemer 125 MG [Mytesi] is in Phase 3 of clinical trials, thus there is some data suggesting its efficacy and multiple rounds of safety testing have been completed. Our team rates it as a 3 on our safety scale."

Answered by AI

What other scientific investigations have included Crofelemer 125 MG [Mytesi]?

"Crofelemer 125 MG [Mytesi] is being studied in 2 different clinical trials, 1 of which is currently in Phase 3. Although most of the research locations are situated in Lafayette, Colorado; there are a total of 15 medical centres running these trials."

Answered by AI
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~58 spots leftby Mar 2025