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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121588
First received: May 10, 2010
Last updated: September 9, 2014
Last verified: September 2014

May 10, 2010
September 9, 2014
March 2011
January 2015   (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 ] [ Designated as safety issue: Yes ]
  • Overall Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Objective Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01121588 on ClinicalTrials.gov Archive Site
  • Duration of Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Plasma concentrations of crizotinib [ Time Frame: 30 Months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
  • Proportion of patients with each of the ALK genetic events [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
  • Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Duration or Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Plasma concentrations of crizotinib [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Proportion of patients with each of the ALK genetic events [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when evaluable [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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 (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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
40
January 2015
January 2015   (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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   United States,   China,   Taiwan,   Japan,   Korea, Republic of,   Russian Federation
 
NCT01121588
A8081013, PROFILE 1013
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

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