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Crofelemer for Preventing Diarrhea in Cancer Patients (OnTARGET Trial)
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.
OnTARGET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOnTARGET Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.OnTARGET Trial Design
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Who is running the clinical trial?
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- I can have chemotherapy and targeted therapy at the same time.I have used laxatives in the past week or needed them for over a month.I have ongoing issues with IBS or colitis.I am 18 years old or older.I am eligible for targeted cancer therapy as per medical guidelines.I can care for myself and am expected to live through the next 12 weeks of therapy.I am to be treated with cancer drugs known to frequently cause diarrhea.I have fecal incontinence due to radiation treatment.I am not pregnant.My cancer is not ALK positive.My cancer has an ALK1 mutation.I am currently being treated for a serious infection.
- Group 1: Placebo
- Group 2: Crofelemer
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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