A Phase I/II Trial of VB-111 and Paclitaxel for Recurrent Platinum-Resistant Müllerian Cancer

• Status: Completed
• Trial end date: 2017-05-03
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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).