Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
This trial is active, not recruiting.
|Condition||non small cell lung cancer (nsclc)|
|Sponsor||UNC Lineberger Comprehensive Cancer Center|
|Start date||May 2011|
|End date||April 2014|
|Trial size||25 participants|
|Trial identifier||NCT01323062, LCCC 1030|
This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Measure number of severe side effects seen during first cycle of therapy
time frame: Three weeks
Progression free survival
time frame: At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death
Male or female participants at least 18 years old.
Inclusion Criteria: - Greater than or equal to 18 - Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy - Evaluable disease by clinical or radiographic parameters - No history or concomitant malignancy - Adequate organ and marrow function - Female subjects with negative urine or serum pregnancy - ECOG must be 0 or 1 Exclusion Criteria: - Squamous cell, small cell, or mixed histology - Known history of bleeding diathesis or coagulopathy - Cavitary tumors or tumors invading or abutting large blood vessels - Any history of thromboembolic events - Ongoing therapy with oral or parenteral anticoagulants - Major surgery within 4 weeks of Day 1 of treatment - Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease) - any history of significant vascular disease - Congestive heart failure - History of any condition requiring anti-platelet therapy - Serious non healing wound - Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis - Unable or unwilling to discontinue use of prohibited medications - D-dimers >2 x ULN as measured on 2 separate occasions at least 1 day apart
|Official title||A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer|
|Principal investigator||Juneko Grilley Olson, MD|
|Description||Subjects with measurable disease will be assessed for response after every 2 cycles of therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated.|
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