EUCTR2006-004451-38-FR
Active, not recruiting
Phase 1
A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND BRAIN METASTASES
Pfizer Inc. - 235 East 42nd Street - New York - 100170 sites60 target enrollmentDecember 20, 2007
Conditionson-Small Cell Lung Cancer (NSCLC) patients with brain metastasesMedDRA version: 8.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic
DrugsSutent
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- on-Small Cell Lung Cancer (NSCLC) patients with brain metastases
- Sponsor
- Pfizer Inc. - 235 East 42nd Street - New York - 10017
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 or 1 prior systemic therapy for the treatment of advanced/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.
Exclusion 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.
Outcomes
Primary Outcomes
Not specified
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