Status:
COMPLETED
A Study of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous NSCLC (PASSPORT)
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Small Cell Lung Cancer
Brain Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) w...
Eligibility Criteria
Inclusion
- Signed informed consent
- Histologically or cytologically confirmed NSCLC except for squamous cell carcinoma
- Treated brain metastases without evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period
- Appropriateness for first- or second-line systemic therapy for advanced NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age ≥ 18 years
- For women of childbearing potential and sexually active males, use of an accepted and effective method of contraception (e.g., hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study
Exclusion
- Brain biopsy/neurosurgical procedure performed within 3 months prior to Day 1
- Progressive neurologic symptoms
- Active malignancy other than lung cancer
- Current, recent, or planned participation in an experimental drug study
- Prior treatment with an investigational or marketed agent that acts by anti-angiogenesis mechanisms
- Gross hemoptysis within 3 months prior to Day 1
- Inadequately controlled hypertension
- Unstable angina or New York Heart Association Grade II or greater congestive heart failure (CHF)
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- Myocardial infarction within 6 months prior to Day 1
- Stroke within 6 months prior to Day 1
- Active symptomatic peripheral vascular disease within 6 months prior to Day 1
- History of significant vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Known hypersensitivity to any components of bevacizumab
- Inadequate organ function
- Serious non-healing wound, ulcer, or bone fracture
- Urine protein/creatinine (UPC) ratio of ≥ 1.0
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
- Pregnancy or lactation
- Known evidence of disseminated intravascular coagulation (DIC)
- Active infection or fever \> 38.5°C within 3 days prior to Day 1
- Any other medical condition (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00312728
Start Date
March 1 2006
End Date
June 1 2009
Last Update
January 6 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.