Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

Peregrine Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Non-small-cell Lung Cancer

Treatments: Drug: Docetaxel plus bavituximab or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01138163

PPHM 0902

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over age 18 years of age with a life expectancy of at least 3 months.
• Histologically or cytologically confirmed stage IIIB or stage IV non squamous non-small-cell lung cancer (NSCLC) who have progressed after 1 chemotherapy regimen.
• Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
• Adequate hematologic, renal, and hepatic function.
• PT/INR ≤ 1.5 × ULN; aPTT time ≤ 1.5 × ULN.
• New York Heart Association classification I or II

Exclusion criteria

• Squamous, small cell, or mixed histology.
• Known history of bleeding diathesis or coagulopathy.
• Cavitary tumors or tumors invading or abutting large blood vessels.
• Bleeding: Clinically significant bleeding such as gross hematuria, GI bleeding and hemoptysis within 12 months of Screening.
• Venous thromboembolic events within 6 months of screening.
• Ongoing therapy with oral or parenteral anticoagulants.
• Concurrent estrogens, anti-estrogens or progesterone compounds.
• Radiotherapy within 2 weeks or major surgery within 4 weeks preceding Study Day 1.
• Symptomatic or clinically active brain metastases.
• Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris within 6 months of screening.
• Grade 2 or higher peripheral neuropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 3 patient groups, including a placebo group

Docetaxel plus bavituximab 1 mg/kg

Experimental group

Treatment:

Drug: Docetaxel plus bavituximab or placebo

Docetaxel plus bavituximab 3 mg/kg

Experimental group

Treatment:

Drug: Docetaxel plus bavituximab or placebo

Docetaxel plus placebo

Placebo Comparator group

Treatment:

Drug: Docetaxel plus bavituximab or placebo