CompletedPhase 3NCT01999673

Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

Checked against the public recordLast updated Apr 21, 2017 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations161
SponsorPeregrine Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Peregrine Pharmaceuticals
Interventions being studied
Biological: bavituximab; Drug: Docetaxel; Other: Placebo (for bavituximab)
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Key Inclusion Criteria: * Male or female at least 18 years of age * Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition) * Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic, renal and hepatic function Exclusion Criteria: * Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC * Known history of bleeding disorders, eg, von Willebrand disease or hemophilia * Cavitary tumors or tumors invading or abutting large blood vessels * Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening * Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening * Grade 2 or higher peripheral neuropathy

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

  • Peregrine Pharmaceuticals Investigational SiteHuntsville, Alabama
  • Peregrine Pharmaceuticals Investigational SiteChandler, Arizona
  • Peregrine Pharmaceuticals Investigational SiteGlendale, Arizona
  • Peregrine Pharmaceuticals Investigational SiteGreenbrae, California
  • Peregrine Pharmaceuticals Investigational SiteLos Angeles, California
  • Peregrine Pharmaceuticals Investigational SiteOceanside, California
  • Peregrine Pharmaceuticals Investigational SiteOrange, California
  • Peregrine Pharmaceuticals Investigational SiteWest Hills, California
  • Peregrine Pharmaceuticals Investigational SiteFort Myers, Florida
  • Peregrine Pharmaceuticals Investigational SiteSt. Petersburg, Florida
  • Peregrine Pharmaceuticals Investigational SiteTampa, Florida
  • Peregrine Pharmaceuticals Investigational SiteAthens, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 21, 2017. Always confirm current availability with the study team.

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