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

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01323062

Collaborator

Peregrine Pharmaceuticals (Industry)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer (NSCLC)	Drug: Bavituximab	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

May 14, 2014

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Single-arm trial Single-arm trial	Drug: Bavituximab Administered 3 mg/kg weekly Other Names: chimeric 3G4

Arm

Intervention/Treatment

Other: Single-arm trial

Single-arm trial

Drug: Bavituximab

Administered 3 mg/kg weekly

Other Names:

chimeric 3G4

Outcome Measures

Primary Outcome Measures

Measure number of severe side effects seen during first cycle of therapy [Three weeks]
To determine the maximum tolerated dose based on occurrence of dose-limititing toxicity (DLT) within the first 3 weeks of treatment to determine appropriate and safe dose of bavituximab in combination with carboplatin and pemetrexed

Secondary Outcome Measures

Progression free survival [At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death]
to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599
2	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15232