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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01121588
First Posted: May 12, 2010
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
May 10, 2010
May 12, 2010
December 14, 2017
March 22, 2011
December 29, 2017   (Final data collection date for primary outcome measure)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities [ Time Frame: 36 Months ]
  • Overall Response Rate [ Time Frame: 36 months ]
  • Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities [ Time Frame: 36 Months ]
  • Objective Response Rate [ Time Frame: 36 months ]
Complete list of historical versions of study NCT01121588 on ClinicalTrials.gov Archive Site
  • Duration of Response [ Time Frame: 36 months ]
  • Plasma concentrations of crizotinib [ Time Frame: 30 Months ]
  • Overall Survival [ Time Frame: 36 Months ]
  • Proportion of patients with each of the ALK genetic events [ Time Frame: 36 Months ]
  • Progression-Free Survival (PFS) [ Time Frame: 36 Months ]
  • Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available [ Time Frame: 36 months ]
  • Progression-free survival [ Time Frame: 36 months ]
  • Overall survival [ Time Frame: 36 months ]
  • Duration or Response [ Time Frame: 36 months ]
  • Plasma concentrations of crizotinib [ Time Frame: 30 months ]
  • Proportion of patients with each of the ALK genetic events [ Time Frame: 30 months ]
  • Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when evaluable [ Time Frame: 36 months ]
Not Provided
Not Provided
 
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