Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

Inclusion Criteria

• Patients to receive targeted cancer therapy drugs that have a reported an all grade diarrhea incidence of 50% or higher (e.g., tyrosine kinase inhibitors, cdk inhibitors, anti-EGFR, etc., for treatment of solid tumors.
• Patients able to provide written informed consent.
• Men and women ≥ 18 years of age.
• Pathologically and/or radiologically confirmed diagnosis of solid tumors scheduled to receive targeted cancer therapy.
• Patients eligible to receive targeted cancer therapy per NCCN (National Comprehensive Cancer Network) guidelines and/or standard-of-care practice, with or without cycle chemotherapy.
• Patient can receive concomitant cycle [standard] chemotherapy agents together with their targeted cancer therapy treatment regimens.
• ECOG (Eastern Cooperative Oncology Group) performance status 0-2 and expected to survive a 12-week course of targeted therapy with or without chemotherapy
• Negative urine pregnancy test at time of informed consent for women of childbearing potential.

Exclusion Criteria

• Patients receiving any type of immunotherapy including but not limited to immune checkpoint inhibitors that inhibit negative regulatory components of immune response such as cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) and the programmed cell death protein-1 and its ligand (PD1/ PDL1) and IL-2 cancer immunotherapy.
• Any cancer therapy for which antidiarrheal (antimotility) medications in the prophylaxis setting is mandatory, including but not limited to patients receiving neratinib and irinotecan.
• Ongoing irritable bowel syndrome (IBS) or colitis (including but not limited to ulcerative colitis, Crohn's disease, microscopic colitis, etc.).
• Ongoing diarrhea and/or diarrheal episodes within the previous 7 days prior to randomization into the study.
• Laxative use within 7 days prior to randomization or a history of constipation requiring the use of laxatives for more than ≥ 30 consecutive days.
• Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days prior to signing consent: Total bilirubin > upper limit of normal (ULN), AST (SGOT) and ALT (SPGT) > 2.5 ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma or hepatic metastases), serum creatinine > 2.0 mg/dL or 177 μmol/L.
• NOTE: Investigator discretion will determine continued eligibility after randomization occurs, in the event the liver function test results are greater than (>) the proposed upper limit of normal.
• Use of other investigational drugs within 4 weeks of signed informed consent or foreseen use during the study.
• Use of antibiotics within the past 7 days (up to 2 prophylactic doses of antibiotic for procedures, including but not limited to port placement, is permitted) prior to randomization.
• Total colectomy and/or any type of gastrointestinal ostomy.
• Major abdominal or pelvic surgery within the past 3 months.
• Previous (within 1 month) or planned abdominal and/or pelvic radiation.
• Fecal incontinence from ongoing radiation-induced diarrhea or constipation
• Active systemic infection requiring ongoing intervention, including but not limited to oral and intravenous antibiotics, anti-fungals, anti-parasitics, and anti-viral drugs.
• Inability to comply with study requirements as judged by the Investigator.
• Pregnant and/or breastfeeding.