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

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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
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Shreveport, Louisiana 71103
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601 Elmwood Avenue
Rochester, New York 14642
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
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801 North 29th Street
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450 Brookline Ave
Boston, Massachusetts 2215
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Brasschaat, Antwerpen
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80 Seymour St
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4733 Sunset Blvd
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Minneapolis, Minnesota 55405
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101 Dudley St
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759 Chestnut Street
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3 Edmund D. Pellegrino Road
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