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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Müllerian Cancer

Conditions
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Platinum Resistant Ovarian Cancer

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VB-111<br> | Drug: Paclitaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define toxicities | Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses. | 2 years |