A Phase 2 Efficacy And Safety Study Of Su011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases - N/A

Pfizer, S.L.U.0 sites60 target enrollmentMarch 29, 2012

Overview

No summary available.

Registry

who.int

Start Date

March 29, 2012

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Pfizer, S.L.U.

•1\. Histologically or cytologically confirmed NSCLC
•2\. Radiologically proven brain metastases secondary to histologically or cytologically confirmed NSCLC. Prior resection of brain metastases is allowed provided at least 1 metastatic brain lesion can be followed by postoperative MRI.
•3\. Previous whole brain radiation therapy ?2 weeks prior to study entry.
•4\. None, 1, or 2 prior systemic therapies for the treatment of dvanced/metastatic NSCLC.
•5\. Patients who received prior systemic therapy for the treatment of NSCLC must have evidence of disease progression.
•6\. Completion of all prior chemotherapy, immunotherapy, and radiotherapy ?4 weeks prior to study entry, and resolution of all acute toxic effects of any prior systemic anticancer therapy, radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ?1\. Note: WBRT may have occurred ?2 weeks prior to study entry.
•7\. For systemic disease, evidence of unidimensionally measurable disease. Measurable brain disease is not required.
•8\. Male or female, 18 years of age or older.
•9\. ECOG performance status 0 or 1\.
•10\. Adequate organ function as defined by the following criteria

•1\. Brainstem lesions, spinal cord compression, carcinomatous meningitis, or
•leptomenengeal disease
•2\. Brain metastases \>4 cm in any linear direction
•3\. Candidate for definitive therapy for brain metastases (e.g. Gamma Knife, surgery).
•4\. Evidence of tonsillar or tentorial herniation
•5\. Intracranial or intratumoral hemorrhage (except those with punctuate asymptomatic intratumoral bleeds).
•6\. Uncontrolled seizure activity
•7\. Treatment with potent CYP3A4 enzyme inducers or inhibitors within the past 2 weeks. Note 1: Patients on steroids must be dose reduced to the lowest possible dose if steroids cannot be completely discontinued.
•Note 2: Steroid dose must be stable (or decreasing) for at least 2 weeks at the time of study entry.Note 3: Patients taking anticonvulsants that affect CYP3A4 enzyme activity (e.g.phenytoin, carbamazepine) must switch to an anticonvulsant that is not a potent enzyme inducer, e.g. Keppra® (levetiracetam).
•8\. Current treatment with therapeutic doses of coumarin\-derivative anticoagulants such as warfarin (however low dose up to 2 mg daily for deep vein thrombosis prophylaxis is permitted) or anti\-vitamin K agents. If currently receiving prophylaxis, PT or INR must be \<1\.5 times the ULN.