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Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

NCT04538625 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2024-07-26

No results posted yet for this study

Summary

A 24-week, (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens. Diarrhea grading will be done according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Patients will be randomized 1:1 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type. Placebo and/or crofelemer will be dispensed at Visit 1/Day 1 with the concurrent start of the targeted cancer therapy regimen. The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles. The Primary and Secondary Endpoints will be analyzed after the last patient last visit (LPLV) of Stage I.

After completing the Stage I double-blind, placebo-controlled primary treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, visit 5 will be the last study visit.

Conditions

  • Cancer Therapy-Related Diarrhea
  • Chemotherapy-related Diarrhea
  • Adult Solid Tumor
  • Prophylaxis of Diarrhea
  • Symptomatic Relief of Diarrhea
  • Targeted Therapy-related Diarrhea

Interventions

DRUG

Crofelemer 125 MG [Mytesi]

Randomized, Double-blind, Placebo-controlled, two arm trial

DRUG

Placebo

Matching placebo tablets

Sponsors & Collaborators

  • Napo Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Pablo Okhuysen, MD · M.D. Anderson Cancer Center

  • Pravin Chaturvedi, PhD · Napo Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2023-08-07
Completion
2023-10-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Georgia
  • Serbia
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04538625 on ClinicalTrials.gov