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What Is the OnTarget 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.

F.A.Q.s

• Which patients qualify for the OnTarget Trial?

  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.

• When must patients be enrolled in the OnTarget Trial?

  Patients must be enrolled before they begin the targeted cancer therapy treatment.

• What is the objective of the OnTarget Protocol?

  The 24-week trial (Protocol NP303-102) will:

  • Evaluate the safety and efficacy of orally administered crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors receiving targeted cancer therapies with or without standard chemotherapy regimens.
  • Assess the frequency of diarrhea as measured by patient-reported loose and/or watery stools based on the Bristol Stool Form Scale.
  • Monitor the mean number of weekly loose and/or watery bowel movements during the 12-week primary treatment period.
  • Evaluate the difference in durable responders in the crofelemer versus placebo groups.
  • After completing the Stage 1, blinded 12-week treatment phase, patients will have the option of remaining on the treatment arm for Stage 2, a blinded 12-week extension period.
• Which targeted therapy drugs are included in the trial?

  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.

• What is the OnTarget Study Design?

  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.

• How many subject visits are required?

  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.

• What medical assessments and procedures are required during the study?
  • Health history/medication history
  • Complete physical examination/vital signs
  • Clinical labs measuring for comprehensive metabolic panel, hematology and urine pregnancy
  • ECOG Performance Status scale
  • Inclusion/exclusion criteria assessment
  • Adverse events reporting
  • Dispension of study drug bottles
  • Drug accountability
  • Concomitant medications reporting
  • Diary compliance