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

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ClinicalTrials.gov Identifier: NCT03398655
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : September 4, 2019
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

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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 100 days following randomization until death from any cause (up to 5 years after last study treatment) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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 ]
  3. 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 ]
  4. 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

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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 (following PARP inhibitor treatment failure, 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 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)
  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

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


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Locations
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United States, Arizona
Arizona Oncology Associates, PC - HAL - USO Recruiting
Phoenix, Arizona, United States, 85016
Contact: Karen Walsh    281-863-2586    karen.walsh@usoncology.com   
Principal Investigator: Bradley Monk, MD         
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Zeno Ashai    323-865-0463    Zeno.Ashai@med.usc.edu   
Principal Investigator: Koji Matsuo, MD         
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange Recruiting
Orange, California, United States, 92868
Contact: Lavinia Dobrea    714-734-6220    Lavinia.Dobrea@stjoe.org   
Principal Investigator: Tariq Mahmood, MD         
University of California, Irvine Medical Center/Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Maria Idelfonso    714-509-2261    midelfon@uci.edu   
Principal Investigator: Krishnansu Tewari, MD         
Sansum Clinic - USO Recruiting
Santa Barbara, California, United States, 93105
Contact: Heidi Heitkamp    281-863-2586    hheitkam@ridleytreecc.org   
Principal Investigator: Thomas Woliver, MD         
United States, Connecticut
Hartford HealthCare Cancer Institute at the Hospital of Central Ct Recruiting
Hartford, Connecticut, United States, 06053
Contact: Sara Putala    860-972-5018    sara.putala@hhchealth.org   
Principal Investigator: Amy B rown, MD         
Hartford Healthcare Recruiting
Hartford, Connecticut, United States, 06106
Contact: Sara Putala    860-972-5018    sara.putala@hhchealth.org   
Principal Investigator: Amy B rown, MD         
United States, Florida
UF Health Recruiting
Gainesville, Florida, United States, 32610
Contact: Melissa Lynn    352-265-0680 ext 87658    Melissa.Lynn@medicine.ufl.edu   
Principal Investigator: Merry Markham, MD         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Antonio Marrero    305-243-6248    axm2830@med.miami.edu   
Principal Investigator: Marilyn Huang, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Stacey Worrell    404-778-5311    stacey.worrell@emory.edu   
Principal Investigator: Namita Khanna, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Lois Winkelman    312-942-2417    lois_a_winkelman@rush.edu   
Principal Investigator: Summer Dewdney, MD         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Michelle Sedberry    217-326-0281    michelle.sedberry@carle.com   
Principal Investigator: Maria Grosse-Perdekamp, MD         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46131
Contact: Rachel Alvey    317-278-6455    rlalvey@iu.edu   
Principal Investigator: Jeanne Schilder, MD         
St. Vincent Gynecologic Oncology Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Cynthia E Cruz    317-415-6747    cynthia.cruzrivera@ascension.org   
Principal Investigator: Michael Callahan, MD         
United States, Kansas
University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Jmaes Jeffery    913-945-8871    jjeffery2@kumc.edu   
Principal Investigator: Andrea Jewell, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Shar Ellixson    859-323-3975    swelli2@uky.edu   
Principal Investigator: Frederick Ueland, MD         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Nicole Duffaut    504-842-2447    nicole.duffaut@ochsner.org   
Principal Investigator: Katrina Wade, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Nancy Tait    410-328-3546    ntait@umm.edu   
Contact: Janie Wangdali    410-328-3546    jwangdali@umm.edu   
Principal Investigator: Dana Marie Roque, MD         
Holy Cross Hospital Recruiting
Silver Spring, Maryland, United States, 20902
Contact: Lyudmila Kalnitskaya    301-754-7552    kalnitsl@holycrosshealth.org   
Principal Investigator: James Barter, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 20114
Contact: Jesse Sardell    617-643-4088    jsardell@mgh.harvard.edu   
Principal Investigator: Richard Penson, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jasmine Hunt    313-576-9382    huntj@karmanos.org   
Principal Investigator: Shelly Morris, 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 Hampshire
Dartmouth- Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Jacqueline M. Kihwele    603-653-9056    Jacqueline.M.Kihwele@hitchcock.org   
Principal Investigator: Evelyn Fleming, MD         
United States, New Jersey
Atlantic Health System/Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07928
Contact: Nancy Ginder    973-971-6608    nancy.ginder@atlantichealth.org   
Principal Investigator: Nana Tchabo, MD         
Rutgers New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
Contact: Randall Teeter    973-972-8367    randall.teeter@njms.rutgers.edu   
Principal Investigator: Mark H Einstein, MD         
United States, New Mexico
New Mexico Cancer Care Alliance Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Sheri Westgate    505-925-0383    swestgate@salud.unm.edu   
Principal Investigator: Carolyn Muller, 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         
Northwell Health Cancer Institute Recruiting
Lake Success, New York, United States, 11042
Contact: Mary Templeton    516-734-8979    Mtempleton@northwell.edu   
Principal Investigator: Veena John, MD         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Nancy Keith    929-455-2422    nancy.keith@nyulangone.edu   
Principal Investigator: Douglas Levine, MD         
Health Quest Medical Practice, Division of Gynecology/Oncology Gyno Dyson Cancer Center Vassar Brothers Medical Center Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Raminder Chadha    845-483-6456    rchadha@Health-quest.org   
Principal Investigator: Heidi Godoy, MD         
United States, North Carolina
Duke University-Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Kara Hagler    919-684-3780    kara.hagler@duke.edu   
Principal Investigator: Angeles Secord, MD         
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Cindy Miller    336-713-6770    cytmill@wakehealth.edu   
Principal Investigator: Samuel Lentz, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Valerie Hagood    513-584-5044    Val.Hagood@ucmail.uc.edu   
Principal Investigator: Thomas Herzog, MD         
Womens Cancer Center/Kettering Cancer Care Recruiting
Kettering, Ohio, United States, 45429
Contact: Wanda Caplinger    937-281-3900    wanda.caplinger@ketteringhealth.org   
Principal Investigator: Thomas Reid, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center-Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Hee Sun Kim-Suh    405-271-8777    HeeSun-Kim@ouhsc.edu   
Principal Investigator: Laura Holman, MD         
United States, Pennsylvania
St. Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Diane Villasenor    484-526-7409    diane.villasenor@sluhn.org   
Principal Investigator: Nicholas Taylor, MD         
The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Linda Crossette    215-614-0234    Linda.Crossette@pennmedicine.upenn.edu   
Principal Investigator: Ashley Haggerty, MD         
United States, South Carolina
GHS Cancer Institute Recruiting
Greenville, South Carolina, United States, 29605
Contact: Gina Norris    864-242-2762    gnorris@ghs.org   
Principal Investigator: Jeffrey Elder, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Anna Dumont    615-936-5173    anna.dumont@vumc.org   
Principal Investigator: Marta Crispens, MD         
United States, Texas
Texas Oncology, Austin Central - USO Recruiting
Austin, Texas, United States, 78731
Contact: Kaelyn Kappeler    512-427-9400    Kaelyn.kappeler@usoncology.com   
Principal Investigator: Michael G Teneriello, MD         
Memorial Hermann Recruiting
Houston, Texas, United States, 77030
Contact: Sonia Robazetti    832-217-5571    sonia.c.robazetti@uth.tmc.edu   
Principal Investigator: Joseph Lucci, MD         
United States, Vermont
Universtiy of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Karen Wilson    802-565-4101    Karen.m.wilson@uvm.edu   
Principal Investigator: Evelyn Cantillo, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Claire Kostechka    608-263-2079    kostechka@wisc.edu   
Principal Investigator: Lisa Barroilhet, MD         
Froedtert and Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Carli Jarman    414-805-6647    cjarman@mcw.edu   
Principal Investigator: William Bradley, 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         
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Shulamit Fried    972- 2-6776709    shulie@hadassah.org.il   
Principal Investigator: David Edelmann, 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:
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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: September 4, 2019
Last Verified: January 2019

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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
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
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