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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 October 11, 2019
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Study Location
Highlands Oncology Group
Fayetteville, Arkansas, 72703 United States
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Contact
1-800-718-1021
[email protected]
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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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Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms Malignant
Intervention  ICMJE Drug: Crizotinib
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Other Name: PF-02341066
Study Arms  ICMJE Experimental: Crizotinib
Intervention: Drug: Crizotinib
Publications *Not Provided


*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 21, 2014)		44
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2010)		40
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion DateDecember 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Italy,   Japan,   Korea, Republic of,   Russian Federation,   Taiwan,   United States
Removed Location CountriesCanada
 
Administrative Information
NCT Number  ICMJE NCT01121588
Other Study ID Numbers  ICMJE A8081013
PROFILE 1013
2010-022978-14 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

ICMJE     Data element required by the

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

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