Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer

Peregrine Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Paclitaxel / Carboplatin; Drug: bavituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01160601

PPHM 1001

Details and patient eligibility

About

This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Adults over 18 years of age with a life expectancy of at least 3 months.
• Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
• Adequate hematologic, renal and hepatic function.
• PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.

Key Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

86 participants in 2 patient groups

paclitaxel/carboplatin plus bavituximab

Experimental group

Description:

Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve \[AUC\] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly.

Treatment:

Drug: Paclitaxel / Carboplatin

Drug: bavituximab

paclitaxel/carboplatin

Active Comparator group

Description:

Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve \[AUC\] 6) on Day 1 of each 21 day cycle for up to 6 cycles.

Treatment:

Drug: Paclitaxel / Carboplatin