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Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of PF-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Non-Small Cell Lung Cancer Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of PF-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Non-Small Cell Lung Cancer Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus


Inclusion Criteria:



- histologically or cytologically proven diagnosis of non-small cell lung cancer

- positive for the ALK fusion gene (test provided by a central laboratory)

- must have had disease progression after only one prior chemotherapy and that regimen
but must have included one platinum drug

- tumors must be measurable

Exclusion Criteria:

- prior treatment with PF-02341066

- current treatment in another clinical trial

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Outcome Time Frame:

Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A8081007

NCT ID:

NCT00932893

Start Date:

September 2009

Completion Date:

December 2014

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms ALK gene crizotinib
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Lymphoma

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLebanon, New Hampshire  03766
Pfizer Investigational SiteHonolulu, Hawaii  96813
Pfizer Investigational SiteProvidence, Rhode Island  02906