A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Criterium, Inc.
Study ID
NCT06992258
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Fruquintinib+ Lonsurf (trifluridine and tipiracil) — DRUG
    Experimental arm
  • Fruquintinib — DRUG
    Standard Of Care Arm

Study Details

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer

Key Dates

Start date
Oct 27, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fruquintinib and Lonsurf
  • Active Comparator: Fruquintinib

Primary Outcome Measure

To estimate the progression-free survival (PFS) benefit of fruquintinib in combination with TAS-102 as compared to fruquintinib [ Time Frame: 24 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520
Sarah Mooney
[email protected]
+1 203-737-5520
Mount Sinai Cancer Research ProgramMiami BeachFlorida33140
Yvonne Enriquez Nunez
[email protected]
305-674-2625
Orlando Health Cancer InstituteOrlandoFlorida32806
Janice Porter
[email protected]
(321) 841-7246
Rutgers Cancer InstituteNew BrunswickNew Jersey08903
Kassie Diorio
[email protected]
NYU Langone HealthNew YorkNew York10016
Mark Bond
[email protected]
212-404-3748
Jennifer Coffey
[email protected]
UPenn Lancaster-Ann B. Barshinger Cancer InstituteLancasterPennsylvania17601
Krista Budzik
[email protected]
717-544-0511
Vanderbilt University Medical CenterNashvilleTennessee37232
Kristen Ciombor, MD
[email protected]
800-811-8480
Mays Cancer Center at University of Texas Health at San AntonioSan AntonioTexas78229
Jennifer Moseley
[email protected]
210-450-1799
Inova Schar CancerFairfaxVirginia22031
Stephanie Van Bebber
[email protected]
571-472-0213

Find similar trials in New Haven, CT

By condition
Colorectal cancer
By specialty
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By research site
Yale University· New Haven, CTMount Sinai Cancer Research Program· Miami Beach, FLOrlando Health Cancer Institute· Orlando, FLRutgers Cancer Institute· New Brunswick, NJNYU Langone Health· New York, NYUPenn Lancaster-Ann B. Barshinger Cancer Institute· Lancaster, PA

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