Platinum Resistant Ovarian Cancer
Conditions
Brief 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.
Interventions
DRUGPaclitaxel
Sponsors
Vascular Biogenics Ltd. operating as VBL Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Define toxicities | 2 years | Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses. |
Countries
United States
Outcome results
None listed