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

Platinum Resistant Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711970
• Other study ID #: VB-111-157
• Secondary ID: 11-418
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2012
• Est. completion date: May 3, 2017

Study information

• Verified date: April 2020
• Source: Vascular Biogenics Ltd. operating as VBL Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01801215

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 3, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Platinum Resistant Ovarian Cancer

Intervention

Drug:
• Paclitaxel

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Biogenics Ltd. operating as VBL Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define toxicities	Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.	2 years