Phase 2
Completed N=115
A Study of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous NSCLC (PASSPORT)
Source: ClinicalTrials.gov NCT00312728 ↗Enrolled (actual)
115
Serious AEs
42.4%
Results posted
Jun 2011
Primary outcomePrimary: Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage — 0 percentage of participants
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) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage |
— | — |
| SECONDARY Overall Survival (OS) in First-line Setting |
11.8 | — |
| SECONDARY Number of Participants With Overall Survival (OS) in First-line Setting [1-Year or More Survival] |
30 | — |
| SECONDARY OS in First-line and Second-line Settings |
12.1 | — |
| SECONDARY Number of Participants With OS in First-line and Second-line Settings [1-Year or More Survival] |
49 | — |
| SECONDARY Number of Participants With Selected Adverse Events |
0; 4; 1; 2; 7; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00312728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.