NCT01323062

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2011

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2014

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

3 years

First QC Date

March 8, 2011

Last Update Submit

December 3, 2018

Conditions

Non Small Cell Lung Cancer (NSCLC)

Keywords

chemotherapy naivestage IV non squamous non small cell lung cancerPhase 1bBavituximabChimeric 3G4U of North Carolina at Chapel Hill

Outcome Measures

Primary Outcomes (1)

  • 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

    Three weeks

Secondary Outcomes (1)

  • Progression free survival

    At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death

Study Arms (1)

Single-arm trial

OTHER

Single-arm trial

Drug: Bavituximab

Interventions

BavituximabDRUG

Administered 3 mg/kg weekly

Also known as: chimeric 3G4
Single-arm trial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

bavituximab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Juneko Grilley Olson, MD

    U of North Carolina at Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 25, 2011

Study Start

May 1, 2011

Primary Completion

May 14, 2014

Study Completion

October 1, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

US(2)