ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL) (OVAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03398655
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
GOG Foundation, Inc.
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Recurrent Platinum Resistant Ovarian Cancer Drug: VB-111 + Paclitaxel Drug: Placebo + Paclitaxel Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined With Paclitaxel vs. Paclitaxel Combined With Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From date of study entry until the date of death from any cause (up to 5 years) ]
  2. Progression Free Survival (PFS) by RECIST 1.1 [ Time Frame: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment ]

Secondary Outcome Measures :
  1. Combined CA-125 and RECIST 1.1 response (GCIG) [ Time Frame: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment ]
  2. CA-125 Response (GCIG) [ Time Frame: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment ]
  3. Objective response rate (ORR) by RECIST 1.1 [ Time Frame: From date of study entry until the date of death from any cause, or up to 5 years after last study treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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:

    • ANC ≥ 1000/mm3
    • PLT ≥ 100,000/mm3
    • PT and PTT (seconds) < 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.

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 abdomen.
  6. Inadequate liver function, defined as:

    • Serum (total) bilirubin > ULN (Exception: documented Gilbert's disease patients can be enrolled)
    • Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases).
  7. Inadequate renal function, defined as:

    • Serum creatinine > ULN OR
    • Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)

7. New York Heart Association (NYHA) Grade II or greater congestive heart failure 8. History of myocardial infarction or unstable angina within 6 months prior to day of randomization.

9. History of stroke or transient ischemic attack within 6 months prior to day of randomization.

10. Patient with proliferative and/or vascular retinopathy 11. Known brain metastases 12. History of hemoptysis or active GI bleeding within 6 month prior to day of randomization 13. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).

14. History of abdominal fistula or gastrointestinal perforation. 15. Current signs and symptoms of bowel obstruction 16. Uncontrolled active infection


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): NCT03398655


Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Richard Penson, MD         
Principal Investigator: Richard Penson, MD         
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59102
Contact: Kathy Wilkinson    406-696-3488    kwilkinson@billingsclinic.org   
Principal Investigator: Benjamin Marchello, MD         
United States, New York
Women's Cancer Care Associates, LLC Recruiting
Albany, New York, United States, 12208
Contact: Kim Fredericks    518-458-1390    kfredericks@womenscancercareassociates.com   
Principal Investigator: Joyce Barlin, MD         
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Tali Lifshits-Gritzman    972-4-7771796    gyn_onco@rambam.health.gov.il   
Principal Investigator: Amnon Amit, MD         
Shaare Tzedek Medical Center Recruiting
Jerusalem, Israel
Contact: Dalia Sherizen    972-2-6555424    daliash@szmc.org.il   
Principal Investigator: Ora Rosengarten, MD         
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Almog Chotiner    03-5307033    Almog.Chotiner@sheba.health.gov.il   
Principal Investigator: Ronnie Shapira-Frommer, MD         
Kaplan Medical Center, Department of Oncology Recruiting
Rehovot, Israel
Contact: Elinor Dahari    972-8-9441007    elinorda@clalit.org.il   
Principal Investigator: Adelya Yachnin, MD         
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
GOG Foundation, Inc.

Additional Information:
Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT03398655     History of Changes
Other Study ID Numbers: VB-111-701/GOG-3018
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
Recurrent Ovarian cancer
Platinum resistant ovarian cancer
Ovarian cancer
Ovarian carcinoma
Epithelial ovarian cancer
paclitaxel

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action