A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

Status: Recruiting
Phase: Phase 1
Diagnosis: Lung Cancer
NCT ID: NCT01970865 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients .

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Alice Shaw, MD, PhD, Massachusetts General Hospital

Site-responsible Investigators:
Leena Gandhi, MD, PhD, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org

Eligibility Criteria

Inclusion Criteria: - Evidence of histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA) approved FISH assay (Abbott Molecular Inc) or by Immunohistochemistry (IHC) (Ventana Inc), or a ROS1 rearrangement as determined by FISH or RT PCR or Next Generation Sequencing (NGS) via a local diagnostic test (LDT). - ALK+ NSCLC patients must either be treatment naïve in the advanced setting or have had disease progression after 1or 2 previous ALK inhibitor therapy(ies), as the last therapy given (Phase 1 allows for intervening chemotherapy). - ROS1+ NSCLC patients must either be treatment naïve in the advanced setting or have had disease progression after 1or 2 previous ROS1 inhibitor therapy(ies), as the last therapy given (Phase 1 allows for intervening chemotherapy). - archival tissue sample available collected prior to enrollment. - All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) are eligible. - Adequate bone marrow, pancreatic, renal, liver function. - Pregnancy test (for females of childbearing potential) negative at screening and at the baseline visit . Male and female patients of childbearing potential must agree to use two highly effective methods of contraception from the time of the first negative pregnancy test at screening, throughout the study and for 90 days after the last dose of assigned treatment. Exclusion Criteria: - Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry. Whole brain radiation must have completed at least 4 weeks prior to study entry. - Any one of the following currently or in the previous 3 months: myocardial infarction, congenital long QT syndrome, Torsades de Pointes, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF NY Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism not adequately medically managed with anticoagulants; as well as bradycardia defined as <50 bpms. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥ 2, symptomatic atrial fibrillation of any grade, or QTc interval >=481 msec at screening. Right bundle branch block. - History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease. - Current use or anticipated need for food or drugs that are known strong or moderate CYP3A4 inhibitors, inducers and CYP3A4 substrates with narrow therapeutic indices. - Concurrent use of drugs that are CYP2C9 substrates with narrow therapeutic indices or those that are sensitive CYP2B6 substrates.
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