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

This study is currently recruiting participants.
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
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VB-111 Drug: Paclitaxel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01711970

Contacts
Contact: Richard Penson, MD 617-726-5867

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
Contact: Richard Penson, MD    617-726-5867      
Principal Investigator: Richard Penson, MD         
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
  More Information

No publications provided

Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT01711970     History of Changes
Obsolete Identifiers: NCT01801215
Other Study ID Numbers: VB-111-157, 11-418
Study First Received: October 18, 2012
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014