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SUPPORTIVE CARE: DIARRHEA PROPHYLAXIS: ON TARGETED THERAPY: ON-TARGET

ON TARGET: A Phase 3 multicenter, randomized, double-blind placebo-controlled trial evaluating crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors
receiving targeted-cancer therapies with or without standard chemotherapy regimens

Title
Napo NP303-102 (ON-TARGET- Diarrhea PPx)
Study Title

ON TARGET: A Phase 3 multicenter, randomized, double-blind placebo-controlled trial evaluating crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors
receiving targeted-cancer therapies with or without standard chemotherapy regimens

Site Link
Malignancy
Breast, Lung, Bladder, Gastric, Esophageal, Kidney, Renal, RCC, NSCLC, Melanoma, thyroid, sarcoma, liver, HCC, GIST, PNET,
Stage
Disease Setting
Supportive Care
Line Of Therapy
Any
Investigational Agent
Crofelemer
Drug Class
Botanical oligomeric proanthocyanidin
PI
Lee Schwartzberg, MD
Sponsor
Napo Pharmaceuticals
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Patient planned to receive one of the following agents for Cancer with or without chemotherapy that has a risk of diarrhea in 50% of patients
    • CDK4/6 inhibitors (abemaciclib, 
    • PI3 kinase blockers (alpelisib,
    • anti-EGFR TKIs (afatinib, dacomitinib, erlotinib, gefitinib) 
    • anti VEGF-TKIs (axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib, sunitinib, vendatinib)
    • anti ALK TKIs (ceritinib, crizotinib)
    • MEK inhibitor (combimetinib) 
    • Anti HER2 TKIs (lapatinib, tucatinib)
  • ECOG PS 0-2
  • Not receiving immunotherapy (PD-1, CTLA-4, IL-2)
  • No diarrhea before enrolling on the study (or starting TKI)
  • No ongoing IBS or colitis
  • Not planning on receiving an agent where anti-diarrheal prophylaxis is mandatory (e.g. neratinib, irinotecan, etc.)
  • No laxative use within 7 days prior to randomization
Objective
  • Primary
    • Frequency of Number of Loose/watery stools
  • Secondary
    • Porportion of Durable Clinical Responders
    • Maximum number of weekly loose/watery stools
    • Fecal incontinence
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Any
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X