A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND BRAIN METASTASES - ND

• Conditions: on-Small Cell Lung Cancer NSCLC patients with brain metastases; MedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic

• Registration Number: EUCTR2006-004451-38-IT
• Lead Sponsor: PFIZER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-06
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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. 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 Serum aspartate aminotransferase AST; serum glutamate-oxalate transferase SGOT and serum alanine aminotransferase ALT; serum glutamate-pyruvate transferase SGPT / 2.5 x upper limit of normal ULN Total serum bilirubin / 1.5 mg/dL Prothrombin time PT / 1.5 x ULN Absolute neutrophil count ANC / 1500/mL Platelets / 100,000/mL Hemoglobin / 9.0 g/dL Serum creatinine / 1.5 x ULN Sodium / 120 mEq/L 11. Signed and dated informed consent document indicating that the patient or legally acceptable representative has been informed of all pertinent aspects of the trial prior to enrollment. 12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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. 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 R levetiracetam . 8. Ongoing treatment with therapeutic doses of Coumadin. 9. Major surgery or radiation therapy 4 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion s is permitted, provided there is at least one measurable lesion that has not been irradiated. Note 1 WBRT must have occurred / 2 weeks prior to study entry. Note 2 Resection of brain metastases is allowed provided at least 1 metastatic lesion is available for follow-up. 10. NCI CTCAE Grade 3 hemorrhage 4 weeks of starting study treatment. 11. Evidence of hemoptysis 4 weeks of starting study treatment. Patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to 5 mL of blood per episode and 10 mL of blood per 24-hour period in the best estimate of the investigator. 12. Uncontrolled hypertension defined as blood pressure 150/100 mm Hg that cannot be controlled with standard antihypertensive agents. 13. Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months. 14. Any of the following within the 12 months prior to study drug administration myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolism. 15. Ongoing cardiac dysrhythmias of NCI CTCAE grade / 2, atrial fibrillation of any grade, or prolongation of the QTc interval to 450 msec for males or 470 msec for females. 16. Known human immunodeficiency virus HIV infection. 17. Current treatment on another therapeutic clinical trial. 18. Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test serum or urine prior to study treatment. 19. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. 20. Receipt of any investigational agent within 4 weeks prior to study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified