Study 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.
Eligible Conditions
- Cancer Therapy-Related Diarrhea
- Prevention of Diarrhea
- Symptomatic Relief of Diarrhea
- Chemotherapy-related Diarrhea
- Targeted Therapy-related Diarrhea
- Solid Tumors, Adult
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Initial 12-week (Stage 1) period of the study.
For the entire 12-week double-blind placebo-controlled treatment period (The Stage 1 Primary Treatment Phase).
Frequency of Number of Loose/watery Stools
Initial 12-week (Stage 1) period of the study.
Fecal Incontinence
Maximum Number of Weekly Loose/Watery Stools
Proportion of Durable, Clinical Responders
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Crofelemer
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
256 Total Participants · 2 Treatment Groups
Primary Treatment: Crofelemer 125 MG [Mytesi] · Has Placebo Group · Phase 3
Crofelemer
Drug
Experimental Group · 1 Intervention: Crofelemer 125 MG [Mytesi] · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: initial 12-week (stage 1) period of the study.
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
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You can take standard chemotherapy drugs with your targeted cancer medication.
References
- Fu, Mei R., Priscilla LeMone, and Roxanne W. McDaniel. 2004. “An Integrated Approach to an Analysis of Symptom Management in Patients with Cancer”. Oncology Nursing Forum. Oncology Nursing Society (ONS). doi:10.1188/04.onf.65-70.
- Di Fiore, Frédéric, and Eric Van Cutsem. 2009. “Acute and Long-term Gastrointestinal Consequences of Chemotherapy”. Best Practice & Research Clinical Gastroenterology. Elsevier BV. doi:10.1016/j.bpg.2008.11.016.
- Benson, Al B., III, Jaffer A. Ajani, Robert B. Catalano, Constance Engelking, Steven M. Kornblau, James A. Martenson Jr, Richard McCallum, et al.. 2004. “Recommended Guidelines for the Treatment of Cancer Treatment-induced Diarrhea”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2004.04.132.
- Carlotto, Alan, Virginia L. Hogsett, Elyse M. Maiorini, Janet G. Razulis, and Stephen T. Sonis. 2013. “The Economic Burden of Toxicities Associated with Cancer Treatment: Review of the Literature and Analysis of Nausea and Vomiting, Diarrhoea, Oral Mucositis and Fatigue”. Pharmacoeconomics. Springer Science and Business Media LLC. doi:10.1007/s40273-013-0081-2.
- Stein, Alexander, Wieland Voigt, and Karin Jordan. 2009. “Review: Chemotherapy-induced Diarrhea: Pathophysiology, Frequency and Guideline-based Management”. Therapeutic Advances in Medical Oncology. SAGE Publications. doi:10.1177/1758834009355164.
- Hirsh, V., N. Blais, R. Burkes, S. Verma, and K. Croitoru. 2014. “Management of Diarrhea Induced by Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors”. Current Oncology. MDPI AG. doi:10.3747/co.21.2241.
- Davila, Marta, and Robert S Bresalier. 2008. “Gastrointestinal Complications of Oncologic Therapy”. Nature Clinical Practice Gastroenterology & Hepatology. Springer Science and Business Media LLC. doi:10.1038/ncpgasthep1277.
- Gibson, Rachel J., and Dorothy M. K. Keefe. 2006. “Cancer Chemotherapy-induced Diarrhoea and Constipation: Mechanisms of Damage and Prevention Strategies”. Supportive Care in Cancer. Springer Science and Business Media LLC. doi:10.1007/s00520-006-0040-y.
- Holodniy, Mark, Johannes Koch, Mark Mistal, Jamey Maimares Schmidt, Atul Khandwala, James E Pennington, and Steven B Porter. 1999. “A Double Blind, Randomized, Placebo-controlled Phase Ii Study to Assess the Safety and Efficacy of Orally Administered Sp-303 for the Symptomatic Treatment of Diarrhea in Patients with AIDS”. American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1111/j.1572-0241.1999.01535.x.
- DiCesare, Daniel, Herbert L. DuPont, John J. Mathewson, David Ashley, Francisco Martinez-Sandoval, James E. Pennington, and Steven B. Porter. 2002. “A Double Blind, Randomized, Placebo-controlled Study of SP-303 (provir) in the Symptomatic Treatment of Acute Diarrhea Among Travelers to Jamaica and Mexico”. The American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1111/j.1572-0241.2002.06027.x.
- Pessi, M.A., N. Zilembo, E.R. Haspinger, L. Molino, S. Di Cosimo, M. Garassino, and C.I. Ripamonti. 2014. “Targeted Therapy-induced Diarrhea: A Review of the Literature”. Critical Reviews in Oncology/hematology. Elsevier BV. doi:10.1016/j.critrevonc.2013.11.008.
- Tradtrantip, Lukmanee, Wan Namkung, and A. S. Verkman. 2009. “Crofelemer, an Antisecretory Antidiarrheal Proanthocyanidin Oligomer Extracted from croton Lechleri, Targets Two Distinct Intestinal Chloride Channels”. Molecular Pharmacology. American Society for Pharmacology & Experimental Therapeutics (ASPET). doi:10.1124/mol.109.061051.
- Mangel, Allen W., and Pravin Chaturvedi. 2008. “Evaluation of Crofelemer in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome Patients”. Digestion. S. Karger AG. doi:10.1159/000185719.
- Bowen, Joanne M.. 2013. “Mechanisms of Tki-induced Diarrhea in Cancer Patients”. Current Opinion in Supportive & Palliative Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/spc.0b013e32835ec861.
- Crutchley, Rustin D, Jennifer Miller, and Kevin W Garey. 2010. “Crofelemer, a Novel Agent for Treatment of Secretory Diarrhea”. Annals of Pharmacotherapy. SAGE Publications. doi:10.1345/aph.1m658.
- MacArthur, Rodger D., Trevor N. Hawkins, Stephen J. Brown, Anthony LaMarca, Patrick G. Clay, Andrew C. Barrett, Enoch Bortey, Craig Paterson, Pamela L. Golden, and William P. Forbes. 2013. “Efficacy and Safety of Crofelemer for Noninfectious Diarrhea in Hiv-seropositive Individuals (ADVENT Trial): A Randomized, Double-blind, Placebo-controlled, Two-stage Study”. HIV Clinical Trials. Informa UK Limited. doi:10.1310/hct1406-261.
- Cottreau, Jessica, Anne Tucker, Rustin Crutchley, and Kevin W Garey. 2012. “Crofelemer for the Treatment of Secretory Diarrhea”. Expert Review of Gastroenterology & Hepatology. Informa UK Limited. doi:10.1586/egh.11.87.
- Nee, Judy, Katherine Salley, Andrew G. Ludwig, Thomas Sommers, Sarah Ballou, Eve Takazawa, Sarah Duehren, et al.. 2019. “Randomized Clinical Trial: Crofelemer Treatment in Women with Diarrhea-predominant Irritable Bowel Syndrome”. Clinical and Translational Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.14309/ctg.0000000000000110.
- Nee, Judy, Katherine Salley, Andrew G. Ludwig, Thomas Sommers, Sarah Ballou, Eve Takazawa, Sarah Duehren, et al.. 2019. “Randomized Clinical Trial: Crofelemer Treatment in Women with Diarrhea-predominant Irritable Bowel Syndrome”. Clinical and Translational Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.14309/ctg.0000000000000110.
- Crutchley RD, Miller J, Garey KW. Crofelemer, a novel agent for treatment of secretory diarrhea. Ann Pharmacother. 2010 May;44(5):878-84. doi: 10.1345/aph.1M658. Epub 2010 Apr 13.
- Benson AB 3rd, Ajani JA, Catalano RB, Engelking C, Kornblau SM, Martenson JA Jr, McCallum R, Mitchell EP, O'Dorisio TM, Vokes EE, Wadler S. Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol. 2004 Jul 15;22(14):2918-26. doi: 10.1200/JCO.2004.04.132.
- Davila M, Bresalier RS. Gastrointestinal complications of oncologic therapy. Nat Clin Pract Gastroenterol Hepatol. 2008 Dec;5(12):682-96. doi: 10.1038/ncpgasthep1277. Epub 2008 Oct 21.
- Bowen JM. Mechanisms of TKI-induced diarrhea in cancer patients. Curr Opin Support Palliat Care. 2013 Jun;7(2):162-7. doi: 10.1097/SPC.0b013e32835ec861.
- DiCesare D, DuPont HL, Mathewson JJ, Ashley D, Martinez-Sandoval F, Pennington JE, Porter SB. A double blind, randomized, placebo-controlled study of SP-303 (Provir) in the symptomatic treatment of acute diarrhea among travelers to Jamaica and Mexico. Am J Gastroenterol. 2002 Oct;97(10):2585-8. doi: 10.1111/j.1572-0241.2002.06027.x.
- Holodniy M, Koch J, Mistal M, Schmidt JM, Khandwala A, Pennington JE, Porter SB. A double blind, randomized, placebo-controlled phase II study to assess the safety and efficacy of orally administered SP-303 for the symptomatic treatment of diarrhea in patients with AIDS. Am J Gastroenterol. 1999 Nov;94(11):3267-73. doi: 10.1111/j.1572-0241.1999.01535.x.
- Gibson RJ, Keefe DM. Cancer chemotherapy-induced diarrhoea and constipation: mechanisms of damage and prevention strategies. Support Care Cancer. 2006 Sep;14(9):890-900. doi: 10.1007/s00520-006-0040-y. Epub 2006 Apr 8.
- Engelking C, Rutledge DN, Ippoliti C, Neumann J, Hogan CM. Cancer-related diarrhea: a neglected cause of cancer-related symptom distress. Oncol Nurs Forum. 1998 Jun;25(5):859-60. No abstract available.
- Di Fiore F, Van Cutsem E. Acute and long-term gastrointestinal consequences of chemotherapy. Best Pract Res Clin Gastroenterol. 2009;23(1):113-24. doi: 10.1016/j.bpg.2008.11.016.
- Carlotto A, Hogsett VL, Maiorini EM, Razulis JG, Sonis ST. The economic burden of toxicities associated with cancer treatment: review of the literature and analysis of nausea and vomiting, diarrhoea, oral mucositis and fatigue. Pharmacoeconomics. 2013 Sep;31(9):753-66. doi: 10.1007/s40273-013-0081-2.
- Cottreau J, Tucker A, Crutchley R, Garey KW. Crofelemer for the treatment of secretory diarrhea. Expert Rev Gastroenterol Hepatol. 2012 Feb;6(1):17-23. doi: 10.1586/egh.11.87.
- Pessi MA, Zilembo N, Haspinger ER, Molino L, Di Cosimo S, Garassino M, Ripamonti CI. Targeted therapy-induced diarrhea: A review of the literature. Crit Rev Oncol Hematol. 2014 May;90(2):165-79. doi: 10.1016/j.critrevonc.2013.11.008. Epub 2013 Dec 5.
- 2020. "Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04538625.
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer