Resources for Investigators

Help Make this Trial a Success: Recruit New Investigators

We want to support your outreach efforts – across practices, within your healthcare system and at other sites. Our Health Care Provider Referral Kit gives you all the tools you need to help OnTARGET reach its enrollment goals.

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Thank You

Thank you for participating in this important clinical trial [NP303-102] to determine if the drug, crofelemer, is effective at preventing or reducing diarrhea in adult patients receiving targeted cancer therapy with or without chemotherapy. As targeted therapies play an ever-increasing role in cancer treatment, your work is vital to finding drugs that ensure both treatment adherence and improved patient quality of life.

Crofelemer is still investigational for this indication. It 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.

Importantly, you can reassure your patients that crofelemer is a safe, effective therapeutic already approved for treating diarrhea in HIV patients.

Help Make this Trial a Success: Recruit New Investigators

We want to support your outreach efforts – across practices, within your healthcare system and at other sites. Our Health Care Provider Referral Kit gives you all the tools you need to help OnTARGET reach its enrollment goals.

We also need your help recruiting new sites to this important study and appreciate any referrals or recommendations.

Inform Your Patients About OnTarget

Help your patients understand the value of participating in this clinical study with our Fit to Fight educational materials.

Download Now

Crofelemer Effectiveness and Safety Profile in HIV-Related Diarrhea

Crofelemer is a novel antidiarrheal drug that blocks chloride ion secretion and accompanying high volume water loss in diarrhea, normalizing the flow of chloride ion and water in the gastrointestinal tract. It is orally administered and negligibly absorbed systemically. Crofelemer has no known drug-drug interactions. It is approved for treating adult patients with HIV-related non-infectious diarrhea, with efficacy and safety shown in various clinical studies when compared to placebo in the following key areas:

  • reduced frequency of loose and/or watery bowel movements was observed through 24 weeks.
  • improved stool consistency

The most common (≤3%) side effects of crofelemer include upper respiratory infections, bronchitis, cough, flatulence, and increased bilirubin.

Learn more about the pivotal phase 3 ADVENT clinical trial in patients with HIV/AIDS.

F.A.Q.s

  • What is the impact of cancer therapy-related diarrhea with targeted therapies?

    As more targeted therapies are approved, fewer cancer patients need to receive intravenous cycle chemotherapy. However, many of the targeted therapies are associated with significant diarrhea. Studies show that as many as 83% of patients receiving targeted therapies may experience diarrhea that may significantly impact their quality of life. Additionally, in some cases, the diarrhea may be frequent enough to cause severe dehydration requiring hospitalization. It is becoming increasingly clear that cancer therapy-related diarrhea may lead to more utilization of expensive healthcare services.

  • What are acceptable patient recruitment sources?
    • Your study site’s patient population starting targeted therapy.
    • Physicians not participating as investigators in this study may refer potential patients for screening.
    • Self-referred patients, if they can easily attend study visits at a participating site.
  • Can I refer sites that are not in my network?

    Yes

  • What are best practices for expanding referrals?

    We are pleased to provide the OnTarget Health Care Provider Referral Kit to assist referral initiatives at your institution.