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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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ClinicalTrials.gov Identifier: NCT01121588
Recruitment Status : Active, not recruiting
First Posted : May 12, 2010
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 10, 2010
First Posted Date  ICMJE May 12, 2010
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE March 22, 2011
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary 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.
Detailed Description Not 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 31, 2022
Estimated Primary Completion Date December 31, 2022   (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 Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT01121588
Other Study ID Numbers  ICMJE A8081013
PROFILE 1013
2010-022978-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2020

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