Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

Pfizer259 sites in 1 country1,069 target enrollmentJanuary 2010

ConditionsCarcinoma, Non-Small-Cell Lung

InterventionsPF-02341066

DrugsPF-02341066

Overview

Phase: Phase 2
Intervention: PF-02341066
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Pfizer
Enrollment: 1069
Locations: 259
Primary Endpoint: Objective Response Rate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

December 2015

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•histologically or cytologically proven diagnosis of non-small cell lung cancer
•positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
•may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
•Tumors can be measurable or non measurable

Exclusion Criteria

•prior treatment with PF-02341066
•received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
•current enrollment in another therapeutic clinical trial

Arms & Interventions

PF-0231066

Intervention: PF-02341066

Outcomes

Primary Outcomes

Objective Response Rate

Time Frame: 6 years

The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.

Percentage of Participants With Adverse Events

Time Frame: 6 years

Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 4.0).

Secondary Outcomes

Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182(6 years)
Duration of Response (DR)(6 years)
Time to Tumor Response (TTR)(6 years)
Disease Control Rate (DCR)(6 years)
Progression Free Survival (PFS)(6 years)
Overall Survival (OS)(6 years)
Probability of Survival(6 years)
Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)(6 years)
Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)(6 years)
QTc Prolongation in Participants(6 years)
Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.(6 years)
Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores(6 years)
Mean Change From Baseline of QLQ-LC13 Scale Scores(6 years)
Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)(6 years)
Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale(6 years)