Summary
This is a prospective, open label, dose escalating, Phase I/II study, measuring mainly the safety and tolerability of the combination of intravenous administration of VB-111 and paclitaxel in patients with platinum resistant ovarian cancer.
Key Facts
Lead Sponsor
Enrollment
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Conditions
Eligibility
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Inclusion Criteria: * Patients aged \> 18 * Histologically confirmed epithelial ovarian, peritoneal, or fallopian tube cancer, and uterine papillary serous carcinomas (UPSC), and gynecologic malignant mixed müllerian tumors (MMMTs). * Must have had prior platinum or platinum based therapy. * Eastern Cooperative Oncology Group (ECOG) status 0-1. * Platinum resistant or refractory disease within 6 months of completing or while receiving a platinum and taxane containing regimen * Measurable disease * Adequate bone marrow and hematological function. * Must have recovered from acute toxicity from prior treatment * Prior treatment with an anti-angiogenic agent is not an exclusion criterion. * No prior GI perforation, or GI obstruction or involvement of the bowel on imaging * Known hypersensitivity to Cremophor EL. However, participants are eligible if they have had a prior paclitaxel reaction, but subsequently tolerated the drug at rechallenge. * No patients receiving other investigational therapy for the past 30 days before dosing. Exclusion Criteria: * More than 3 prior lines of chemotherapy for recurrent cancer. * History of other active malignancy, other than superficial basal cell and superficial squamous cell, or carcinoma in situ of the cervix within last 2 years. * Life expectancy of less than 3 months * CTC Grade 1 or greater neuropathy (motor or sensory) from comorbidity other than prior taxane exposure, such as diabetes. * Inadequately controlled hypertension or prior history of hypertensive crisis or hypertensive encephalopathy. * New York Heart Association (NYHA) Grade II or greater congestive heart failure. * History of myocardial infarction or unstable angina within 6 months prior to study Day 1. * History of stroke or transient ischemic attack within 6 months prior to Day 1. * Known CNS disease, except for treated brain metastasis * Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1. * History of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1. * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).