West Cancer Center

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

Site Link

NCT04538625

Malignancy

Breast, Lung, Bladder, Gastric, Esophageal, Kidney, Renal, RCC, NSCLC, Melanoma, thyroid, sarcoma, liver, HCC, GIST, PNET,

Stage

Stage 4

Disease Setting

Supportive Care

Line Of Therapy

Any

Investigational Agent

Crofelemer

Drug Class

Botanical oligomeric proanthocyanidin

Lee Schwartzberg, MD

Sponsor

Napo Pharmaceuticals

Phase

Phase 3

Status

Closed to Accrual

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 (cobimetinib)
- 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

Assessment Frequency Link

Path

Any

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes