Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

NCT02824094 | Unknown

• 1 other identifier: A8081064
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

Primary objective of this study is to allow access and evaluate the safety of crizotinib for patients in Japan with advanced NSCLC harboring a translocation or inversion involving the ROS1 oncogene.

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung

Keywords

Expanded Access Protocol; crizotinib; Xalkori; ROS1; Japanese; A8081064

Interventions

crizotinib DRUG

Crizotinib, 250 mg BID, will be administered orally on a continuous daily dosing schedule

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
• Positive for translocation or inversion events involving the ROS1 gene as determined by protocol defined test.
• ECOG performance status 0 to 2.
• Adequate organ function
• Patients with brain metastases are eligible if neurologically stable for at least 2 weeks and have no ongoing requirement for corticosteroids.
• Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after the last dose of crizotinib.

You may not qualify if:

• Currently receiving crizotinib or any investigational products.
• Prior therapy specifically directed against ROS1 fusion genes including crizotinib.
• Carcinomatous meningitis or leptomeningeal disease.
• Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function.
• Ongoing uncontrolled congestive heart failure (CHF) and any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
• Ongoing cardiac dysrhythmias of CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QTc more than 480 msec.
• History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
• Pregnant female patients; breastfeeding female patients.
• Use of drugs or foods including known potent CYP3A4 inhibitors, known potent CYP3A4 inducers and CYP3A4 substrates with narrow therapeutic indices

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Aichi cancer center central hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Hyogo Cancer Center

Akashi, Hyōgo, 673-8558, Japan

Location

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Crizotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 6, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

JP (4)