A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

Part of paid clinical trials in Fullerton, California.

Sponsor
Pfizer
Study ID
NCT01937715
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Carcinoma

Eligibility Criteria

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

Interventions

  • PF-05212384 — DRUG
    PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly
  • FOLFIRI regimen — DRUG
    The RP2D/MTD dose of FOLFIRI regimen every 2 weeks
  • Bevacizumab — BIOLOGICAL
    5 mg/m\^2 every 2 weeks or 7.5 mg/m\^2 every 3 weeks
  • FOLFIRI — DRUG
    Full dose FOLFIRI regimen every 2 weeks

Study Details

This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI. The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.

Key Dates

First listed
Sep 9, 2013
Start date
Feb 28, 2014
Status verified
Jul 2016
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    PF-05212384 plus FOLFIRI
  • Active Comparator: Arm B
    Bevacizumab plus FOLFIRI

Primary Outcome Measure

Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy [ Time Frame: Day 1 up to Day 28 ]

Locations (35)

FacilityCityStateZIPSite coordinators
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage HealthcareFullertonCalifornia92835-
UCLA Hematology OncologyIrvineCalifornia92604-
Drug Management Only: UCLA West Medical PharmacyLos AngelesCalifornia90095-7349-
Drug Management Only: UCLA West Medical Pharmacy, Attn Steven L. Wong, Pharm .D.Los AngelesCalifornia90095-7349-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
Ronald Regan UCLA Medical Center, Drug Information CenterLos AngelesCalifornia90095-
TRIO_USLos AngelesCalifornia90095-
TRIO-US Central AdministrationLos AngelesCalifornia90095-
TRIO-US Central Administration, Regulatory Management OnlyLos AngelesCalifornia90095-
UCLA Hematology Oncology Administrative AddressLos AngelesCalifornia90095-
UCLA West Medical Pharmacy, Att: Steven L. Wong, Pharm D.Los AngelesCalifornia90095-7349-
Westwood Bowyer Clinic, Peter Morton Medical BuildingLos AngelesCalifornia90095-
West Valley Hematology/Oncology Med GroupNorthridgeCalifornia91328-
UCLA/Pasadena HealthcarePasadenaCalifornia91105-
Central Coast Medical Oncology CorporationSanta MariaCalifornia93454-
UCLA Hematology OncologySanta MonicaCalifornia90404-
UCLA Santa Monica Medical Center & Orthopaedic HospitalSanta MonicaCalifornia90404-
UCLA/Santa Clarita Valley Cancer CenterValenciaCalifornia91355-
UCLA Cancer CenterWestlake VillageCalifornia91361-
Comprehensive Cancer Centers of NevadaHendersonNevada89052-
Comprehensive Cancer Centers of NevadaHendersonNevada89074-
Comprehensive Cancer Centers of Nevada Research DepartmentHendersonNevada89014-
Comprehensive Cancer Centers for NevadaLas VegasNevada89169-
COmprehensive Cancer Centers of NevadaLas VegasNevada89148-
Comprehensive Cancer Centers of NVLas VegasNevada89128-
Metrohealth Medical CenterClevelandOhio44109-
Medical Group of the Carolinas - Hematology SpartanburgSpartanburgSouth Carolina29303-
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303-
Kadlec Clinic Hematology and OncologyKennewickWashington99336-
Kadlec Medical CenterRichlandWashington99352-
Outpatient Imaging CenterRichlandWashington99352-
Investigational Drug ServicesSeattleWashington98101-
Virginia Mason Medical CenterSeattleWashington98101-
Medical Oncology Associates, PSSpokaneWashington99208-
Spokane Valley Cancer CenterSpokane ValleyWashington99216-

Find similar trials in Fullerton, CA

By research site
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare· Fullerton, CAUCLA Hematology Oncology· Irvine, CADrug Management Only: UCLA West Medical Pharmacy· Los Angeles, CADrug Management Only: UCLA West Medical Pharmacy, Attn Steven L. Wong, Pharm .D.· Los Angeles, CARonald Reagan UCLA Medical Center· Los Angeles, CARonald Regan UCLA Medical Center, Drug Information Center· Los Angeles, CA

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