CompletedPhase 1NCT01323062

Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects

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).

Checked against the public recordLast updated Dec 4, 2018 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations2
SponsorUNC Lineberger Comprehensive Cancer Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
UNC Lineberger Comprehensive Cancer Center
Interventions being studied
Drug: Bavituximab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina
  • University of Pittsburgh Medical CenterPittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 4, 2018. Always confirm current availability with the study team.

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