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. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Drug: Bavituximab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 25
Study Start Date: May 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bavituximab
    Administered 3 mg/kg weekly
    Other Name: chimeric 3G4
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323062

Contacts
Contact: Donna Rowe, RN (919) 966-7359 donna_rowe@med.unc.edu

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Juneko Grilley Olson, MD    919-966-4432    juneko_grilley@med.unc.edu   
United States, Pennsylvania
University of Pittsburgh Medical Center Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Peregrine Pharmaceuticals
Investigators
Principal Investigator: Juneko Grilley Olson, MD U of North Carolina at Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01323062     History of Changes
Other Study ID Numbers: LCCC 1030
Study First Received: March 8, 2011
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
chemotherapy naive
stage IV non squamous non small cell lung cancer
Phase 1b
Bavituximab
Chimeric 3G4
U of North Carolina at Chapel Hill

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014