Study of Bavituximab plus Paclitaxel and Carboplatin in patients with Non small Cell Lung Cancer.

Phase 2

Completed

• Registration Number: CTRI/2008/091/000128
• Lead Sponsor: Peregrine Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 49

Inclusion Criteria

1. Written informed consent has been obtained
2. Adults over age 18 years of age with a life expectancy of at least 3 months
3. Histologically confirmed stage IIIB (with pleural effusion), stage IV, or recurrent non-small cell lung cancer
4. Measurable disease on cross sectional imaging that is at least 2 cm in longest diameter (1 cm if measured by spiral CT)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
6. Adequate hematologic function (Absolute Neutrophil Count (ANC) ≥ 1,500 cells/µL; Hemoglobin > 9 g/dL, platelets > 100,000/µL and ≤ 500,000/µL)
7. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min)
8. Adequate hepatic function (bilirubin ≤ 1.5 x ULN, alanine amino transferase (ALT) ≤ 3 x ULN, aspartate amino transferase (AST) ≤ 3 x ULN)
9. Prothrombin time / international normalized ratio within institutional normal limits
10. Activated partial thromboplastin time ≤ 1.5 ULN
11. D-dimer ≤ 2 x ULN
12. New York Heart Association classification I or II
13. Female patients must have a negative serum pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)

Exclusion Criteria

1. Prior exposure to any chimeric antibody
2. Small cell or mixed histology
3. Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
4. Any current evidence (or history in 12 months) of clinically significant bleeding defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
5. Any history of thromboembolic events in the last 12 months [e.g., deep vein thrombosis (DVT) or pulmonary thromboembolism (PE)] including central venous catheter-related thrombosis
6. Ongoing therapy with oral or parenteral anticoagulants; patients on low dose anticoagulants to maintain patency of lines are eligible
7. Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen)
8. Significant peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
9. Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
10. Radiotherapy within 2 weeks preceding Study Day 1
11. Symptomatic or clinically active CNS
12. Major surgery within 4 weeks of Study Day 1
13. Pregnant or nursing women
14. All patients of reproductive potential must agree to use an approved form of barrier contraception
15. Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
16. Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
17. Cardiac arrhythmia requiring medical therapy
18. A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin
19. Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture)
20. Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs (e.g., phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids
21. Known chronic infection with HIV or viral hepatitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the overall response rate (complete response +partial response) to a combination of Bavituximab plus Carboplatin and Paclitaxel in patients with previously untreated locally advanced or metastatic non-small cell lung cancerTimepoint: To determine the overall response rate at Cycle 3 Day 1, Cycle 5 Day 1, and every 2 months after treatment during follow-up until disease progression

Secondary Outcome Measures

Name	Time	Method
Time to tumor progression, duration of response, overall survival, Safety as determined by the type, frequency, severity and relationship of adverse events to study drugs.Timepoint: Time from start of treatment to tumor progression measured at Cycle 3 Day 1, Cycle 5 Day 1, and every 2 months after treatment during follow-up until disease progression