Know Cancer

or
forgot password

Phase 2, Open-Label Single Arm Study Of The Efficacy And Safety Of PF-02341066 In Patients With Non-Small Cell Lung Cancer Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

Phase 2, Open-Label Single Arm Study Of The Efficacy And Safety Of PF-02341066 In Patients With Non-Small Cell Lung Cancer Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene


Inclusion Criteria:



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

- positive for the ALK fusion gene (test provided by either a central laboratory.
Local laboratory may be used for certain cases)

- may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and
discontinued treatment due to Response Evaluation Criterion in Solid Tumors
(RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has
been analyzed and the results made available, at any time without RECIST-defined
progression.

- Tumors can be measurable or non measurable

Exclusion Criteria:

- prior treatment with PF-02341066

- received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor,
for advanced non-small cell lung cancer

- current enrollment in another therapeutic clinical trial

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

30 months

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:

A8081005

NCT ID:

NCT00932451

Start Date:

January 2010

Completion Date:

December 2013

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 SiteBirmingham, Alabama  35205
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 SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLebanon, New Hampshire  03766
Pfizer Investigational SiteHonolulu, Hawaii  96813
Pfizer Investigational SiteProvidence, Rhode Island  02906