A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

Part of paid clinical trials in Bakersfield, California.

Sponsor
Pfizer
Study ID
NCT01925274
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • PF-05212384 — DRUG
    30 minute IV infusion of PF-05212384 on days 2, 9, 16 and 23 of each cycle. Intra-patient dose escalation will commence with 110mg and will increase depending on tolerability.
  • irinotecan — DRUG
    90 minutes IV infusion of irinotecan 180mg/m\^2 on days 1 and 15 of each cycle
  • Cetuximab — DRUG
    120 minute IV infusion of cetuximab 400mg/m\^2 on cycle 1 day 1; 60 minute IV infusion of cetuximab on days 8, 15, and 22 of each cycle, and on day 1 of each cycle after cycle 1
  • Irinotecan — DRUG
    90 minutes IV infusion of Irinotecan 180mg/m\^2 on days 1 and 15 of each cycle

Study Details

This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.

Key Dates

Start date
Nov 15, 2013
Status verified
Dec 2018
Primary completion
Apr 6, 2016
Completion
Apr 6, 2016

Study Design

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

Arms

  • Experimental: Arm A
    PF-05212384 plus Irinotecan
  • Active Comparator: Arm B
    Cetuximab plus Irinotecan

Primary Outcome Measure

Progression Free Survival (PFS) as Assessed by Investigators [ Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years ]

Locations (25)

FacilityCityStateZIPSite coordinators
CBCC Global Research, Inc. at Comprehensive Blood and Cancer CenterBakersfieldCalifornia93309-
Drug Management Only: UCLA West Medical PharmacyLos AngelesCalifornia90095-7349-
Drug Management Only: UCLA West Medical Pharmacy, Att: Steven L Wong, Pharm DLos AngelesCalifornia90095-7349-
Regulatory Management Only: TRIO-US Central AdministrationLos AngelesCalifornia90095-
TRIO_USLos AngelesCalifornia90095-
TRIO-US Central Administration (Regulatory Management only)Los AngelesCalifornia90095-
UCLA West Medical PharmacyLos AngelesCalifornia90095-7349-
West Valley Hematology/Oncology Med GroupNorthridgeCalifornia91328-
Siteman Cancer Center - St PetersCity of Saint PetersMissouri63376-
Siteman Cancer Center - West CountyCreve CoeurMissouri63141-
Barnes-Jewish HospitalSt LouisMissouri63110-
Siteman Cancer Center - South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Comprehensive Cancer Centers of NevadaHendersonNevada89052-
Comprehensive Cancer Centers of NevadaHendersonNevada89074-
Regulatory Office: Comprehensive Cancer Centers of NevadaHendersonNevada89014-
Comprehensive Cancer Centers of NevadaLas VegasNevada89128-
Comprehensive Cancer Centers of NevadaLas VegasNevada89148-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Roswell Park Cancer InstituteBuffaloNew York14263-
Kadlec Clinic Hematology and OncologyKennewickWashington99336-
Kadlec Medical CenterRichlandWashington99352-
Outpatient Imaging CenterRichlandWashington99352-
Medical Oncology Associates, PSSpokaneWashington99208-
Spokane Valley Cancer CenterSpokane ValleyWashington99216-

Find similar trials in Bakersfield, CA

By research site
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center· Bakersfield, CADrug Management Only: UCLA West Medical Pharmacy· Los Angeles, CADrug Management Only: UCLA West Medical Pharmacy, Att: Steven L Wong, Pharm D· Los Angeles, CARegulatory Management Only: TRIO-US Central Administration· Los Angeles, CATRIO_US· Los Angeles, CATRIO-US Central Administration (Regulatory Management only)· Los Angeles, CA

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