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Regorafenib Monotherapy as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer

NCT02619435 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-03-24

No results posted yet for this study

Summary

The purpose of this study is to purpose of this study is to assess if regorafenib is active enough, in terms of 6-month progression-free rate, to warrant further comparative studies in patients with RAS-mutant advanced colorectal cancer who have progressed after first-line oxaliplatin-based chemotherapy plus bevacizumab.

Conditions

  • Advanced Colorectal Cancer

Interventions

DRUG

regorafenib

Patients will receive regorafenib orally 160 mg once daily for the first 3 weeks of each 4-week cycle.

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Antonio Avallone, M.D. · National Cancer Institute, Naples

  • Alfredo Budillon, M.D. · National Cancer Institute, Naples

  • Francesco Perrone, M.D. · National Cancer Institute, Naples

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Italy

Study Locations

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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 NCT02619435 on ClinicalTrials.gov