A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)
Trial Status: Active
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.
- Female patients ≥18 years of age
- Histologically confirmed epithelial ovarian cancer and documented disease.
- Patients must have platinum-resistant disease
- Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
- ECOG PS 0-1.
- 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.
- 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).
- Non-epithelial tumors (Carcino-sarcomas are excluded)
- Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.
- 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.
- Previous ovarian cancer treatment with >5 anticancer regimens.
- Any prior radiotherapy to the pelvis or whole abdomen.
- 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).
- Inadequate renal function, defined as:
- Serum creatinine > ULN OR
- Calculated creatinine clearance < 50ml/min (by Cockroft & Gault formula)
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
- History of stroke or transient ischemic attack within 6 months prior to day of randomization.
- Patient with proliferative and/or vascular retinopathy
- Known brain metastases
- History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- History of abdominal fistula or gastrointestinal perforation.
- Current signs and symptoms of bowel obstruction
- Uncontrolled active infection
- 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
Banner University Medical Center - Tucson
USC / Norris Comprehensive Cancer Center
Contact: Grace M Facio
UC Irvine Health / Chao Family Comprehensive Cancer Center
UCSF Medical Center-Mount Zion
Contact: Helen Diller Family Comprehensive Cancer Center
University of Miami Miller School of Medicine-Sylvester Cancer Center
Emory Saint Joseph's Hospital
Emory University Hospital / Winship Cancer Institute
Emory University Hospital Midtown
Indiana University / Melvin and Bren Simon Cancer Center
Contact: Rachel Lynn Alvey
University of Kansas Cancer Center
Contact: Adam Hisham Al Douri
University of Kentucky / Markey Cancer Center
University of Maryland / Greenebaum Cancer Center
Contact: Janie Wangdali
Massachusetts General Hospital Cancer Center
Wayne State University / Karmanos Cancer Institute
Dartmouth Hitchcock Medical Center
Rutgers New Jersey Medical School
University of New Mexico Cancer Center
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Duke University Medical Center
Wake Forest University Health Sciences
University of Oklahoma Health Sciences Center
University of Pennsylvania / Abramson Cancer Center
Vanderbilt University / Ingram Cancer Center
University of Wisconsin Hospital and Clinics
Trial Phase Phase III
Trial Type Treatment
- Primary ID VB-111-701/GOG-3018
- Secondary IDs NCI-2018-01995
- Clinicaltrials.gov ID NCT03398655