An Open-Label, Randomized, Phase II Trial of Durvalumab (MEDI4736) With or Without Bavituximab in Patients With Previously Treated Metastatic Non-Small Cell Lung Cancer

Peregrine Pharmaceuticals0 sitesFebruary 2016

ConditionsNon-Small Cell Lung Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non-Small Cell Lung Cancer
Sponsor: Peregrine Pharmaceuticals
Primary Endpoint: Objective Response Rate (ORR)
Status: Withdrawn
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

April 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peregrine Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed Written Informed Consent
•Male or female at least 18 years of age
•Histologically or cytologically documented NSCLC (Non-small-cell lung carcinoma) who present with Stage IV disease (according to the American Joint Committee on Cancer Staging Manual \[7th edition\]) or with recurrent disease or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease)
•Disease recurrence or progression during or after one prior platinum-based doublet chemotherapy treatment for advanced or metastatic disease
•Measurable disease on cross-sectional imaging per RECIST 1.1
•Eastern Cooperative Oncology Group performance status 0 or 1
•Tumor tissue (archival or recent tumor biopsy) must be available for biomarker evaluation
•Adequate hematologic function (absolute neutrophil count ≥1500 cells/µL; hemoglobin ≥9 g/dL; platelets ≥100,000/µL).
•Serum creatinine CL\>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
•Adequate hepatic function (serum bilirubin ≤1.5 × ULN, serum albumin levels ≥3.0 g/dL, alanine aminotransferase \[ALT\] ≤2.5 × ULN, and aspartate aminotransferase \[AST\] ≤2.5 × ULN)

Exclusion Criteria

•Known history of bleeding diathesis or coagulopathy (von Willebrand disease or hemophilia)
•Tumors invading large blood vessels that, in the opinion of the Investigator, put the patient at risk for major hemorrhage
•Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding, and hemoptysis within the 6 months before screening, unless the cause has been identified and adequately treated (eg, cystitis, ulcer)
•Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months before screening
•Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction, arterial embolism, or unstable angina pectoris within 6 months prior to screening
•QT interval using Fridericia's Correction (QTc) \> 500 ms
•Symptomatic or clinically active brain metastases. Patients are eligible if brain metastases are adequately treated. Patients must be either off corticosteroids or on a stable or decreasing dose of ≤10 mg of daily prednisone (or equivalent).
•Patients with symptomatic interstitial lung disease or inflammatory pneumonitis that may interfere with the detection or management of suspected drug-related pulmonary toxicity
•Other active malignancy requiring concurrent intervention.
•Acute toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 or baseline before administration of study drug