Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Study ID
NCT03829462
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer (mCRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Regorafenib — DRUG
    regorafenib tab 40 mg i.e 160 mg/day
  • Irinotecan — DRUG
    irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more

Study Details

Patients with metastatic colorectal cancer (mCRC) who have received all approved standard treatments (except Regorafenib and Lonsurf) no longer have treatment options available while maintaining a good performance status which would allow them to receive a new treatment

Key Dates

Start date
Mar 28, 2019
Status verified
Nov 2025
Primary completion
Sep 4, 2024
Completion
Sep 30, 2026

Study Design

Enrollment
377 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan + regorafenib (REGIRI)
    irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8
  • Active Comparator: regorafenib
    Regorafenib (160 mg/day) for 3 weeks followed by 1 week off

Primary Outcome Measure

Overall Survival [ Time Frame: Up to 36 months ]

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