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CompletedPhase 1NCT01323062
Official study title

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

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBavituximab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 4, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?UNC Lineberger Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
UNC Lineberger Comprehensive Cancer Center
Interventions being studied
Drug: Bavituximab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina
  • University of Pittsburgh Medical CenterPittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 4, 2018. Always confirm current availability with the study team.

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