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

December 3, 2018 updated by: UNC Lineberger Comprehensive Cancer Center

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Lineberger Comprehensive Cancer Center, UNC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure number of severe side effects seen during first cycle of therapy
Time Frame: 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
Three weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 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
At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Peregrine Pharmaceuticals

Investigators

  • Principal Investigator: Juneko Grilley Olson, MD, U of North Carolina at Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 14, 2014

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 25, 2011

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 1030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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