Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pfizer
Study ID
NCT00965731
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only)
  • Erlotinib — DRUG
    For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2
  • PF-02341066 — DRUG
    For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2

Study Details

This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.

Key Dates

First listed
Aug 26, 2009
Start date
Jan 31, 2010
Status verified
Oct 2015
Primary completion
Dec 31, 2011
Completion
Jan 31, 2014

Study Design

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

Arms

  • Active Comparator: Erlotinib
  • Experimental: Erlotinib + PF-02341066

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1) [ Time Frame: Baseline up to Day 28 ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
University of Alabama at BirminghamBirminghamAlabama35294-
University of California IrvinOrangeCalifornia92868-
University of California, Irvine Medical Center PharmacyOrangeCalifornia92868-3298-
University of California, Irving - Medical CenterOrangeCalifornia92868-3298-
Holy Cross HospitalFort LauderdaleFlorida33308-
Siteman Cancer CenterCity of Saint PetersMissouri63376-
Siteman Cancer Center -West CountyCreve CoeurMissouri63141-
Barnes-Jewish HospitalSt LouisMissouri63110-1094-
Washington University, School of MedicineSt LouisMissouri63110-
James Care in KennyColumbusOhio43221-
OSU EastColumbusOhio43205-
The Ohio State University James Cancer HospitalColumbusOhio43210-
Cancer Therapy & Research Center @ UTHSCSASan AntonioTexas78229-
Seattle Cancer Care AllianceSeattleWashington98109-
University of Washington Medical CenterSeattleWashington98195-

Find similar trials in Birmingham, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California Irvin· Orange, CAUniversity of California, Irvine Medical Center Pharmacy· Orange, CAUniversity of California, Irving - Medical Center· Orange, CAHoly Cross Hospital· Fort Lauderdale, FLSiteman Cancer Center· City of Saint Peters, MO

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