Overview

This trial is active, not recruiting.

Condition non small cell lung cancer (nsclc)
Treatment bavituximab
Phase phase 1
Target phosphotidylserine
Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborator Peregrine Pharmaceuticals
Start date May 2011
End date April 2014
Trial size 25 participants
Trial identifier NCT01323062, LCCC 1030

Summary

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

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Single-arm trial
bavituximab chimeric 3G4
Administered 3 mg/kg weekly

Primary Outcomes

Measure
Measure number of severe side effects seen during first cycle of therapy
time frame: Three weeks

Secondary Outcomes

Measure
Progression free survival
time frame: At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.