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

Phase 3

Completed

• Conditions: Recurrent Platinum Resistant Ovarian Cancer
• Interventions: Drug: VB-111 + Paclitaxel; Drug: Placebo + Paclitaxel

• Registration Number: NCT03398655
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-19
• Study First Submitted: 2018-01-07
• Study First Submitted QC: 2018-01-07
• Study First Posted: 2018-01-12
• Status Verified: 2021-06
• Primary Completion: 2022-07-19
• Study Completion: 2022-07-19
• Last Update Submitted: 2023-01-08
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 408

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	VB-111 + Paclitaxel	VB-111 + Paclitaxel
Arm 2	Placebo + Paclitaxel	Placebo + Paclitaxel

Primary Outcome Measures

Name	Time	Method
Overall Survival	From randomization until death from any cause (up to 5 years after last study treatment)
Progression Free Survival (PFS) by RECIST 1.1	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

Name	Time	Method
Combined CA-125 and RECIST 1.1 response (GCIG)	From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
Objective response rate (ORR) by RECIST 1.1	From date of study entry until the date of death from any cause, or up to 5 years after last study treatment
OS100 for a sensitivity analysis of OS	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
CA-125 Response (GCIG)	From date of study entry until the date of death from any cause, or up to 5 years after last study treatment

Trial Locations

Locations (93)

UAB Division of GYN Oncology; 🇺🇸 Birmingham, Alabama, United States

Western Regional Medical Center; 🇺🇸 Goodyear, Arizona, United States

Arizona Oncology Associates, PC - HAL - USO; 🇺🇸 Tempe, Arizona, United States

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

UCLA-JCCC-Women's Health Clinical Research Unit; 🇺🇸 Los Angeles, California, United States

The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange; 🇺🇸 Orange, California, United States

University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

University of California - San Francisco; 🇺🇸 San Francisco, California, United States

Sansum Clinic - USO; 🇺🇸 Santa Barbara, California, United States

Olive View UCLA Medical Center; 🇺🇸 Sylmar, California, United States

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