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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics Identifier:
First received: October 18, 2012
Last updated: August 17, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Platinum Resistant Ovarian Cancer Drug: Paclitaxel Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Müllerian Cancer

Resource links provided by NLM:

Further study details as provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:

Primary Outcome Measures:
  • Define toxicities [ Time Frame: 2 years ]
    Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.

Estimated Enrollment: 38
Study Start Date: November 2012
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VB-111 Drug: Paclitaxel


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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).
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Please refer to this study by its identifier: NCT01711970

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
  More Information

Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics Identifier: NCT01711970     History of Changes
Obsolete Identifiers: NCT01801215
Other Study ID Numbers: VB-111-157
11-418 ( Other Identifier: DF/HCC )
Study First Received: October 18, 2012
Last Updated: August 17, 2016

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017