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

This study is currently recruiting participants.
Verified February 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Peregrine Pharmaceuticals
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01323062
First received: March 8, 2011
Last updated: February 28, 2014
Last verified: February 2014

March 8, 2011
February 28, 2014
May 2011
May 2016   (final data collection date for primary outcome measure)
Measure number of severe side effects seen during first cycle of therapy [ Time Frame: Three weeks ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01323062 on ClinicalTrials.gov Archive Site
Progression free survival [ Time Frame: At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death ] [ Designated as safety issue: Yes ]
to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed
Same as current
Not Provided
Not Provided
 
Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer

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).

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer (NSCLC)
Drug: Bavituximab
Administered 3 mg/kg weekly
Other Name: chimeric 3G4
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
May 2018
May 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Donna Rowe, RN (919) 966-7359 donna_rowe@med.unc.edu
United States
 
NCT01323062
LCCC 1030
Yes
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
Peregrine Pharmaceuticals
Principal Investigator: Juneko Grilley Olson, MD U of North Carolina at Chapel Hill
UNC Lineberger Comprehensive Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP