A Phase I/II Trial of VB-111 and Paclitaxel for Recurrent Platinum-Resistant Müllerian Cancer
Sponsored by Vascular Biogenics Ltd. operating as VBL Therapeutics
About this trial
Last updated 5 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 8 years ago
What is this trial about?
What are the participation requirements?
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).