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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


Phase 1
15 Years
N/A
Open (Enrolling)
Both
Neoplasms Malignant

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

36 months

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A8081013

NCT ID:

NCT01121588

Start Date:

March 2011

Completion Date:

January 2015

Related Keywords:

  • Neoplasms Malignant
  • neoplasm malignant
  • lymphoma
  • neuroblastoma
  • Crizotinib
  • anaplastic lymphoma kinase
  • ALK
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lymphoma

Name

Location

Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteEasley,, South Carolina  29640