Become an Investigator
Help find solutions for Targeted Therapy-Induced Diarrhea by becoming an OnTarget Investigator
Learn if you’re qualified to be an OnTarget investigator and enroll patients in this study
The OnTarget supportive care study is a phase 3, multicenter, randomized clinical trial (Protocol NP303-102) evaluating the effectiveness of the novel drug, crofelemer, in the prophylaxis of diarrhea in adult patients with solid tumors receiving targeted therapies with or without chemotherapy. Crofelemer is an FDA-approved drug with an established safety profile and demonstrated efficacy for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.
Only patients who have not begun targeted therapy and are not scheduled for immunotherapy are eligible for this trial.
Cancer treatment-related diarrhea (CTD) is a common and sometimes severe side effect for which supportive care solutions are critically needed. CTD often necessitates dose reductions and treatment breaks, which may compromise clinical outcomes. CTD also can affect patients’ ability to receive proper nutrition, which is key to their treatment success and overall health.
Because targeted therapies show much promise and are increasingly used for treating solid tumors, preventing and mitigating diarrhea is critical for both treatment adherence and patient quality of life.
Crofelemer reduces intestinal chloride ion and fluid secretion. In various clinical trials, it demonstrated efficacy when compared to placebo in reducing loose or watery bowl movement frequency and improving stool consistency.
The pivotal phase 3 Advent clinical trial in HIV/AIDS patients receiving antiretroviral therapy led to approval of crofelemer at a twice-daily, 125-mg. dose for the symptomatic relief of noninfectious diarrhea in these patients.
Crofelemer was well-tolerated in HIV+ individuals with diarrhea in multiple clinical studies. It is not systemically absorbed and has no known drug-drug interactions.
Adult, non-pregnant patients newly diagnosed with solid tumors who are scheduled to initiate a targeted cancer therapy that has a reported incidence of all-grade diarrhea incidence of 50 percent or higher. Patients can be receiving standard chemotherapy but cannot be receiving any type of immunotherapy.
Patients must be enrolled before they begin the targeted cancer therapy treatment.
The 24-week trial (Protocol NP303-102) will:
Targeted cancer therapy drugs that have a reported all-grade diarrhea incidence of 50% or higher, including tyrosine kinase inhibitors, cdk 4/6 inhibitors, and anti-EGFR mutations.
The 24-week (two 12-week stages) study will evaluate safety and efficacy of crofelemer for treating CTD in adult patients receiving targeted therapy for solid tumors with or without cycle chemotherapy. Patients will be randomized 1:1 to either placebo or crofelemer and stratified by the type of targeted therapy and tumor type. Subjects will take the study drug (crofelemer or placebo) orally, twice daily for 12 weeks (Stage 1). Subjects will record every bowel movement and answer daily and weekly diary questions via smartphone, tablet, or computer. After completion of Stage 1, patients will have the option of continuing on their assigned arm, and, if so, will need to reconsent.
Interactive web recognition software will collect data through diary recordings of stool frequency and characteristics, as well as urgency, fecal incontinence and abdominal pain or discomfort.
The protocol includes 8 subject visits over 24 weeks (4 may be telehealth visits), as well as possible unscheduled, as-needed visits at the discretion of the investigator.