Clinical Trials /

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

NCT03398655

Description:

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.

Related Conditions:
  • Malignant Ovarian Epithelial Tumor
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: VB-111-701/GOG-3018
  • NCT ID: NCT03398655

Conditions

  • Recurrent Platinum Resistant Ovarian Cancer

Interventions

DrugSynonymsArms
VB-111 + PaclitaxelArm 1
Placebo + PaclitaxelArm 2

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.

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalVB-111 + Paclitaxel
  • VB-111 + Paclitaxel
Arm 2Active ComparatorPlacebo + Paclitaxel
  • Placebo + Paclitaxel

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival
Time Frame:From date of study entry until the date of death from any cause (up to 5 years)
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Vascular Biogenics Ltd. operating as VBL Therapeutics

Trial Keywords

  • Recurrent Ovarian cancer
  • Platinum resistant ovarian cancer
  • Ovarian cancer
  • Ovarian carcinoma
  • Epithelial ovarian cancer
  • paclitaxel

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