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

Completed · Phase 1

Conditions studied: Non Small Cell Lung Cancer (NSCLC)

In brief

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).

Key facts

Study ID

NCT01323062

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

26

Starts

2011-05-01

Expected to finish

2018-10-01

Last updated by the study team

2018-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lineberger Comprehensive Cancer Center, UNC — Chapel Hill, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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