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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03398655
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : January 10, 2023
Sponsor:
Collaborator:
GOG Foundation
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 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
Actual Primary Completion Date : July 19, 2022
Actual Study Completion Date : July 19, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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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
Other Name: Ofranergene Obadenovec
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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization until death from any cause (up to 5 years after last study treatment) ]
  2. Progression Free Survival (PFS) by RECIST 1.1 [ Time Frame: From randomization until progression defined according to RECIST 1.1 or death, whichever occurs first (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 ]
  4. OS100 for a sensitivity analysis of OS [ Time Frame: From 100 days after date of study entry until the date of death from any cause, or up to 5 years after last study treatment ]

Eligibility Criteria
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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.
  7. 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):

    • 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)
  8. New York Heart Association (NYHA) Grade II or greater congestive heart failure
  9. History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
  10. History of stroke or transient ischemic attack within 6 months prior to day of randomization.
  11. Patient with proliferative and/or vascular retinopathy
  12. Known brain metastases
  13. History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
  14. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
  15. History of abdominal fistula or gastrointestinal perforation.
  16. Current signs and symptoms of bowel obstruction
  17. Uncontrolled active infection
  18. 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
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): NCT03398655


Locations
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Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
GOG Foundation
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT03398655    
Other Study ID Numbers: VB-111-701/GOG-3018
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: June 2021

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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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Recurrence
Disease Attributes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
 Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action