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

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ClinicalTrials.gov Identifier: NCT01711970
Recruitment Status : Active, not recruiting
First Posted : October 23, 2012
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Platinum Resistant Ovarian Cancer Drug: Paclitaxel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
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
Study Start Date : November 2012
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: VB-111 Drug: Paclitaxel


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711970


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
More Information
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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 ( Other Identifier: DF/HCC )
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action