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

NCT ID: NCT01711970

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2017-05-03

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.

Conditions

Platinum Resistant Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VB-111

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Interventions

Paclitaxel

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vascular Biogenics Ltd. operating as VBL Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Arend RC, Beer HM, Cohen YC, Berlin S, Birrer MJ, Campos SM, Rachmilewitz Minei T, Harats D, Wall JA, Foxall ME, Penson RT. Ofranergene obadenovec (VB-111) in platinum-resistant ovarian cancer; favorable response rates in a phase I/II study are associated with an immunotherapeutic effect. Gynecol Oncol. 2020 Jun;157(3):578-584. doi: 10.1016/j.ygyno.2020.02.034. Epub 2020 Apr 5.

Reference Type: DERIVED

PMID: 32265057 (View on PubMed)

Other Identifiers

11-418

Identifier Type: OTHER

Identifier Source: secondary_id

VB-111-157

Identifier Type: -

Identifier Source: org_study_id

NCT01801215

Identifier Type: -

Identifier Source: nct_alias