Metformin Plus Irinotecan for Refractory Colorectal Cancer

Sponsor
Barretos Cancer Hospital
Study ID
NCT01930864
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • metformin — DRUG
    metformin up to 2500mg/d
  • irinotecan — DRUG
    Irinotecan 350 mg/m² IV q21d

Study Details

MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.

Key Dates

Start date
Sep 1, 2015
Status verified
Jun 2017
Primary completion
Dec 1, 2020
Completion
Dec 1, 2020

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: metfomin + irinotecan
    Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal

Primary Outcome Measure

Non-Progression at week 12th of treatment [ Time Frame: 12th week ]

Central Contacts

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