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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Platinum Resistant Ovarian Cancer

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

VB-111-157

NCT ID:

NCT01711970

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Platinum Resistant Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617