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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

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NCT00932451

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00932451
Pfizer
Completed
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

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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
Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
Drug: PF-02341066
PF-02341066, 250 mg BID, will be administered orally on a continuous schedule
Experimental: PF-0231066
Intervention: Drug: PF-02341066


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1069
December 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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,   United States
Argentina
 
NCT00932451
A8081005
2009-012504-13 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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