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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT01711970
First received: October 18, 2012
Last updated: January 6, 2014
Last verified: January 2014

October 18, 2012
January 6, 2014
November 2012
October 2014   (final data collection date for primary outcome measure)
Define toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.
Not Provided
Complete list of historical versions of study NCT01711970 on ClinicalTrials.gov Archive Site
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A Phase I/II Trial of VB-111 and Paclitaxel for Recurrent Platinum-Resistant Müllerian Cancer
A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Müllerian Cancer

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Platinum Resistant Ovarian Cancer
Drug: Paclitaxel
Experimental: VB-111
Intervention: Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
38
Not Provided
October 2014   (final data collection date for primary outcome measure)

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).
Female
18 Years and older
No
Contact: Richard Penson, MD 617-726-5867
United States
 
NCT01711970
VB-111-157, 11-418
Yes
Vascular Biogenics Ltd. operating as VBL Therapeutics
Vascular Biogenics Ltd. operating as VBL Therapeutics
Not Provided
Not Provided
Vascular Biogenics Ltd. operating as VBL Therapeutics
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP