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

Primary Purpose

Non Small Cell Lung Cancer (NSCLC)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bavituximab
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer (NSCLC) focused on measuring chemotherapy naive, stage IV non squamous non small cell lung cancer, Phase 1b, Bavituximab, Chimeric 3G4, U of North Carolina at Chapel Hill

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lineberger Comprehensive Cancer Center, UNC
  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm trial

Arm Description

Single-arm trial

Outcomes

Primary Outcome Measures

Measure number of severe side effects seen during first cycle of therapy
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
to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed

Full Information

First Posted
March 8, 2011
Last Updated
December 3, 2018
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Peregrine Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01323062
Brief Title
Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 14, 2014 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Peregrine Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer (NSCLC)
Keywords
chemotherapy naive, stage IV non squamous non small cell lung cancer, Phase 1b, Bavituximab, Chimeric 3G4, U of North Carolina at Chapel Hill

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm trial
Arm Type
Other
Arm Description
Single-arm trial
Intervention Type
Drug
Intervention Name(s)
Bavituximab
Other Intervention Name(s)
chimeric 3G4
Intervention Description
Administered 3 mg/kg weekly
Primary Outcome Measure Information:
Title
Measure number of severe side effects seen during first cycle of therapy
Description
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
Time Frame
Three weeks
Secondary Outcome Measure Information:
Title
Progression free survival
Description
to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed
Time Frame
At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juneko Grilley Olson, MD
Organizational Affiliation
U of North Carolina at Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.unclineberger.org
Description
web address for Lineberger Comprehensive Cancer Center, UNC
URL
http://www.cancer.gov
Description
web address for the National Cancer Institute (NCI)

Learn more about this trial

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

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