Patient case: 56-year-old female with melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Safety and Tolerability Study of an Edible Colon Preparation

Summary: The purpose of this study is to learn about a new bowel preparation that uses food to clean the colon.
  In order to learn about this new food preparation, some people in this study will get the food preparation, and others will get the standard liquid bowel preparation.
  Patients will be randomized (like flipping a coin) to one of five groups:
  Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY

Detailed description: The purpose of this Phase 2 formulation screening/proof of concept study is to evaluate the safety, tolerability, and efficacy of up to 3 ECP-019 formulations/dosing regimens comprising a PEG 3350 Colon Prep Kit, containing electrolytes provided by the foods, in 3 formulations/ dosing regimens as compared to 2 comparators in a Phase 2 study.

Eligibility: Inclusion Criteria:
  -  Patients whose physician has prescribed colonoscopy for colorectal cancer screening or surveillance for colorectal cancer.
  -  Patients with a previous history of completing a bowel cleansing procedure for a colonoscopy.
  -  For women of child bearing potential, a negative pregnancy test.
  -  Patients who are willing and able to comply with study procedures.
  -  Documentation of informed consent by the use of a written consent form approved by the IRB and signed and dated by the patient.
  Exclusion Criteria:
  -  Known intestinal stricture of any etiology.
  -  History of diabetes mellitus.
  -  Pregnancy.
  -  Patients with renal insufficiency defined as a Cr >2.0 or a history of hypo- or hyperkalemia, chronic liver disease, congestive heart failure, or arrhythmic disorder (i.e., higher risk of complications from electrolyte abnormalities than healthy patients).
  -  Patients being treated with warfarin, heparin (standard or low molecular weight heparin) or clopidogrel, Pradaxa®, Xarelto®, Effient® or other anticoagulant agents.
  -  Previous history of inadequate preparation for a colonoscopy.
  -  Patients with a history of colonic resection, Crohn's disease, or ulcerative colitis.
  -  Severe psychological disease causing functional impairment limiting capacity to complete the preparation.
  -  Use of narcotics/opiates within 2 weeks prior to the procedure.
  -  Use of anti-diarrheal within 2 weeks prior to the procedure.
  -  Use of drugs of abuse, including abused prescription medications.
  -  Use of iron oral supplements within 2 weeks of the procedure.
  -  Previous gastrointestinal surgery.
  -  A known diagnosis of gastroparesis.
  -  Symptoms of chronic constipation defined as fewer than three bowel movements per-week on average over the previous 3 months.
  -  Clinically significant laboratory abnormalities as judged by the study investigator from blood tests drawn at Screening study visit.
  -  Patients with any known allergies to the ingredients of the test products (aspartame, gluten, lactose, milk, peanuts, sesame, soy, tree nuts, or wheat) or comparator products.
  -  Patients with phenylketonuria (PKU) or a known sensitivity to the artificial sweetener called aspartame.

Relevance to patient case: not relevant