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 May 2013 by Pfizer

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00932451

First received: June 30, 2009

Last updated: May 3, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2009

Last Updated Date

May 3, 2013

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00932451 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
Time to Tumor Response [ Time Frame: 30 months ] [ Designated as safety issue: No ]
QTc [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
genotypes of alleles possibly associated with adverse hepatic or renal drug reactions [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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 ]
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 ]
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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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 also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Drug: PF-02341066

PF-02341066, 250 mg BID, will be administered orally on a continuous schedule

Study Arm (s)

Experimental: PF-0231066

Intervention: Drug: PF-02341066

Publications *

Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1100

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States, Australia, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Sweden, Taiwan, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00932451

Other Study ID Numbers ^ICMJE

A8081005

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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