Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK)

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Neoplasms Malignant

Treatments: Drug: Crizotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01121588

A8081013

2010-022978-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Crizotinib

Experimental group

Treatment:

Drug: Crizotinib