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Purpose

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Female patients ≥18 years of age
  2. Histologically confirmed epithelial ovarian cancer and documented disease.
  3. Patients must have platinum-resistant disease
  4. Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
  5. ECOG PS 0-1.
  6. Adequate hematological functions:
  7. ANC ≥ 1000/mm3
  8. PLT ≥ 100,000/mm3
  9. PT and PTT (seconds) < 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.
  10. Patients who are known to carry a BRCA mutation may be enrolled only after (following PARP inhibitor treatment failure, or being intolerant of, or ineligible for PARP inhibitor treatment).

Exclusion Criteria

  1. Non-epithelial tumors (Carcino-sarcomas are excluded)
  2. Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.
  3. History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma, adequately controlled, non-metastatic squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
  4. Previous ovarian cancer treatment with >5 anticancer regimens.
  5. Any prior radiotherapy to the pelvis or whole abdomen.
  6. Inadequate liver function, defined as serum creatinine > ULN, unless calculated creatinine clearance > 50ml/min (by Cockroft & Gault formula):
  7. Serum (total) bilirubin > ULN (Exception: documented Gilbert's disease patients can be enrolled)
  8. Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases).
  9. Inadequate renal function, defined as:
  10. Serum creatinine > ULN OR
  11. Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)
  12. New York Heart Association (NYHA) Grade II or greater congestive heart failure
  13. History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
  14. History of stroke or transient ischemic attack within 6 months prior to day of randomization.
  15. Patient with proliferative and/or vascular retinopathy
  16. Known brain metastases
  17. History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
  18. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
  19. History of abdominal fistula or gastrointestinal perforation.
  20. Current signs and symptoms of bowel obstruction
  21. Uncontrolled active infection
  22. Patients who had evidence of disease progression during or up to 90 days from the last dose of the first line of platinum based therapy

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1
VB-111 + Paclitaxel
  • Drug: VB-111 + Paclitaxel
    VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
Active Comparator
Arm 2
Placebo + Paclitaxel
  • Drug: Placebo + Paclitaxel
    Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Shar Ellixson
859-323-3975
swelli2@uky.edu

More Details

NCT ID
NCT03398655
Status
Recruiting
Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.