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An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

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NCT01121588

Last updated on July 31, 2018
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FOR MORE INFORMATION
Study Location
Highlands Oncology Group
Fayetteville, Arkansas, 72703 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.
Neoplasms Malignant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15+ 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 malignancy other than NSCLC

- positive for translocation or inversion event involving the ALK gene locus

- positive for ALK amplification events

- positive for ALK activating point mutations

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

- mutations of amplifications involving the c-Met gene but not the ALK gene

- concurrent treatment on another therapeutic clinical trial

- prior therapy specifically directed against ALK

NCT01121588
Pfizer
Active, not recruiting
An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)
Phase 1b Open-label Study Of The Safety And Clinical Activity Of Crizotinib (Pf-02341066) In Tumors With Genetic Events Involving The Anaplastic Lymphoma Kinase (Alk ) Gene Locus
This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms Malignant
Drug: Crizotinib
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Other Name: PF-02341066
Experimental: Crizotinib
Intervention: Drug: Crizotinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
44
December 29, 2017
December 29, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • histologically or cytologically proven diagnosis of malignancy other than NSCLC
  • positive for translocation or inversion event involving the ALK gene locus
  • positive for ALK amplification events
  • positive for ALK activating point mutations

Exclusion Criteria:

  • mutations of amplifications involving the c-Met gene but not the ALK gene
  • concurrent treatment on another therapeutic clinical trial
  • prior therapy specifically directed against ALK
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Italy,   Japan,   Korea, Republic of,   Russian Federation,   Taiwan,   United States
Canada
 
NCT01121588
A8081013
PROFILE 1013
2010-022978-14 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

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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1-800-718-1021

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[email protected]



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