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An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
This study is currently recruiting participants.
Verified by Pfizer, February 2010
First Received: June 30, 2009   Last Updated: February 6, 2010   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00932451
  Purpose

This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
 Drug: PF-02341066
 Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics
MedlinePlus related topics: Cancer Lung Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Type, incidence, severity, seriousness and relationship to study medication of adverse events and laboratory test abnormalities [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Patient reported symptoms of lung cancer and health-related quality of life [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of PF-02341066 [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Types of EML4-ALK fusion variants and ALK gene expression [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Protein expression of identified biomarkers in serial tumor samples (when available) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: January 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PF-0231066: Experimental Drug: PF-02341066
PF-02341066, 250 mg BID, will be administered orally on a continuous schedule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically or cytologically proven diagnosis of non-small cell lung cancer
  • positive for ALK gene
  • received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression

Exclusion Criteria:

  • prior treatment with PF-02341066
  • received no prior chemotherapy for advanced non-small cell lung cancer
  • current enrollment in another therapeutic clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932451

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com

Locations
United States, California
Pfizer Investigational Site Not yet recruiting
Beverly Hills, California, United States, 90211
Pfizer Investigational Site Not yet recruiting
Beverly Hills, California, United States, 90211-1850
Pfizer Investigational Site Not yet recruiting
Bakersfield, California, United States, 93309
United States, Connecticut
Pfizer Investigational Site Recruiting
New Haven, Connecticut, United States, 06519
Pfizer Investigational Site Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Pfizer Investigational Site Not yet recruiting
Fort Lauderdale, Florida, United States, 33308
Pfizer Investigational Site Not yet recruiting
Lake Worth, Florida, United States, 33461
United States, Massachusetts
Pfizer Investigational Site Recruiting
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site Recruiting
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Pfizer Investigational Site Recruiting
Lake Success, New York, United States, 11042
Pfizer Investigational Site Recruiting
Manhasset, New York, United States, 11030
Pfizer Investigational Site Recruiting
New Hyde Park, New York, United States, 11040
United States, Rhode Island
Pfizer Investigational Site Recruiting
East Providence, Rhode Island, United States, 02914
Pfizer Investigational Site Recruiting
East Providence, Rhode Island, United States, 02915
United States, Washington
Pfizer Investigational Site Not yet recruiting
Seattle, Washington, United States, 98104
Pfizer Investigational Site Not yet recruiting
Seattle, Washington, United States, 98122
Australia, New South Wales
Pfizer Investigational Site Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Pfizer Investigational Site Not yet recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Pfizer Investigational Site Recruiting
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A8081005
Study First Received: June 30, 2009
Last Updated: February 6, 2010
ClinicalTrials.gov Identifier: NCT00932451     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Lung Neoplasms ALK gene

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases
 Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on February 08, 2010



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