A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer

Phase 2 Open-label Single Arm Study Of The Efficacy And Safety Of Crizotinib In East Asian Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus

This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event involving the ALK gene locus who have received only one prior chemotherapy regimen for advanced NSCLC and this regimen must have been platinum-based. Primary objective of this study is to assess the anti-tumor activity and safety profile of crizotinib. Secondary objectives are to evaluate clinical efficacy including median progression-free survival (PFS) and 1-year PFS rate, overall survival (OS), disease control rate (DCR) at 6 and 12 weeks, time to response (TTR), and duration of response (DR).

Study Overview

• Status: Withdrawn
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Crizotinib

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Proven diagnosis of locally advanced or metastatic non-squamous cell carcinoma of the lung
• Positive for translocation or inversion events involving the ALK gene locus
• Patients must have had progressive disease after only one prior chemotherapy regimen. This regimen must have been platinum-based and may have included maintenance therapy.
• Evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.

Exclusion Criteria:

• Current treatment on another therapeutic clinical trial.
• Prior therapy directly targeting ALK.
• Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
• Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
• Pregnancy or breastfeeding.
• Use of drugs or foods that are known potent CYP3A inducers/inhibitors/substrates with narrow therapeutic indices.
• Known HIV infection
• Known interstitial lung disease or interstitial fibrosis
• Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Crizotinib	Drug: Crizotinib; Crizotinib, 250 mg BID, will be administered orally at approximately the same time each day on a continuous daily dosing schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	33 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-Free Survival	33 months
Overall Survival	33 months
Disease Control Rate	33 months
Duration of Response	33 months
Time To Response	33 months

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ANTICIPATED): May 1, 2016
• Study Completion (ANTICIPATED): May 1, 2016

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (ESTIMATE): December 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: NSCLC; Non-Small Cell Lung Cancer; Asian; ALK; Crizotinib
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Crizotinib
• Other Study ID Numbers: A8081027