A Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:October 24, 2018
End Date:July 31, 2023
Contact:Beth Zaharoff
Email:bzaharoff@tesarobio.com
Phone:781-209-5485

Use our guide to learn which trials are right for you!

ENGOT-0V44 The FIRST (First-line Ovarian Cancer Treatment With Niraparib Plus TSR-042) Study: A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

This is a global, multicenter, randomized, double-blind, controlled Phase 3 study in patients
with newly diagnosed, Stage III or IV non mucinous epithelial ovarian, fallopian tube, or
peritoneal cancer (collectively referred to as "ovarian cancer"). The currently recommended
standard of care therapy for the first line treatment of Stage III or IV ovarian cancer is
the combination of paclitaxel and carboplatin, with or without concurrent and maintenance
bevacizumab.


Inclusion Criteria:

- Patients with a histologically confirmed diagnosis of high-grade nonmucinous
epithelial ovarian cancer (serous, endometrial, clear cell, carcinosarcoma, an mixed
pathologies) that is Stage III or IV according to the International Federation of
Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria.

- All patients with Stage IV disease are eligible. This includes those with inoperable
disease, those who undergo primary debulking surgery (complete cytoreduction (CC0) or
macroscopic disease), or those for whom neoadjuvant chemotherapy is planned.

- Patients with Stage III are eligible if they meet one or more of the following
criteria:

1. High risk Stage IIIC disease.

2. Planning to receive neoadjuvant chemotherapy.

- Patients must provide a blood sample for research at Screening.

- Patient must provide a formalin-fixed paraffin embedded tumor tissue sample at
Screening for research.

- Patients must have adequate organ function (Note: complete blood count test should be
obtained without transfusion or receipt of stimulating factors within 2 weeks before
obtaining Screening blood sample)

- Patients must have an ECOG score of 0 or 1.

- Patients must have normal BP or adequately treated and controlled hypertension
(systolic BP ≤140 mmHg and/or diastolic BP ≤90 mmHg).

- Patients must agree to complete HRQoL questionnaires throughout the study.

- Patients must be able to take oral medication.

Exclusion Criteria:

- Patient has mucinous, germ cell, transitional cell, or undifferentiated tumor.

- Patient has low-grade or Grade 1 epithelial ovarian cancer.

- Stage III patient with complete cytoreduction (CC0) resection after primary debulking
surgery (ie, no macroscopic residual disease, unless the patient has aggregate 5 cm
extra-pelvic disease during primary debulking surgery.

- Patient has not adequately recovered from prior major surgery.

- Patient has a known condition, therapy, or laboratory abnormality that might confound
the study results or interfere with the patient's participation for the full duration
of the study treatment in the opinion of the Investigator.

- Patient has been diagnosed and/or treated with any therapy for invasive cancer <5
years from study enrollment, completed adjuvant chemotherapy and/or targeted therapy
(eg, trastuzumab) less than 3 years from enrollment, or completed adjuvant hormonal
therapy less than 4 weeks from enrollment. Patients with definitively treated
non-invasive malignancies such as cervical carcinoma in situ, ductal carcinoma in
situ, Grade 1 or 2, Stage IA endometrial cancer, or non-melanomatous skin cancer are
allowed.

- Patient is at increased bleeding risk due to concurrent conditions (eg, major injuries
or major surgery within the past 28 days prior to start of study treatment and/or
history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or
clinically significant hemorrhage within the past 3 months).

- Patient is immunocompromised. Patients with splenectomy are allowed. Patients with
well-controlled known human immunodeficiency virus (HIV) are allowed.

- Patient has known active hepatitis B (eg, hepatitis B surface antigen reactive) or
hepatitis C (eg, hepatitis C virus ribonucleic acid [qualitative] is detected).

- Patient is considered a poor medical risk due to a serious, uncontrolled medical
disorder, non-malignant systemic disease, or active, uncontrolled infection.

- Patient has had investigational therapy administered within 4 weeks or within a time
interval less than at least 5 half-lives of the investigational agent, whichever is
longer, prior to the first scheduled day of dosing in this study.

- Patient has received a live vaccine within 14 days of planned start of study therapy.
Seasonal influenza vaccines that do not contain live viruses are allowed.

- Patient has a known contraindication or uncontrolled hypersensitivity to the
components of paclitaxel, carboplatin, niraparib, bevacizumab, TSR-042, or their
excipients.
We found this trial at
40
sites
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
?
mi
from
Billings, MT
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Brasschaat, Antwerpen
?
mi
from
Brasschaat,
Click here to add this to my saved trials
Canton, Ohio 44710
?
mi
from
Canton, OH
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Covington, Louisiana 70433
?
mi
from
Covington, LA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Eugene, OR
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Geneva, IL
Click here to add this to my saved trials
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kennewick, Washington 99336
?
mi
from
Kennewick, WA
Click here to add this to my saved trials
4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Minneapolis, Minnesota 55405
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
325 West 15th Street
New York, New York 10011
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15232
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97227
?
mi
from
Portland, OR
Click here to add this to my saved trials
101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
?
mi
from
Providence, RI
Click here to add this to my saved trials
Salt Lake City, Utah 84106
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Shreveport, Louisiana 71103
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Silver Spring, Maryland 20910
?
mi
from
Silver Spring, MD
Click here to add this to my saved trials
759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
?
mi
from
Springfield, MA
Click here to add this to my saved trials
3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Teaneck, New Jersey 07666
?
mi
from
Teaneck, NJ
Click here to add this to my saved trials
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
Tyler, Texas 75702
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Worcester, Massachusetts 01605
?
mi
from
Worcester, MA
Click here to add this to my saved trials
Zion, Illinois 60099
?
mi
from
Zion, IL
Click here to add this to my saved trials