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
- Conditions
- adenocarcinoma10033283ovarian cancer
- Registration Number
- NL-OMON54558
- Lead Sponsor
- TESARO, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 38
To be considered eligible to participate in this study, all of the following
requirements must be met:
1. Patients must be female, >=18 years of age, able to understand the study
procedures, and agree to participate in the study by providing written informed
consent.
2. Patients with a histologically confirmed diagnosis of high-grade
nonmucinous epithelial ovarian (serous, endometrioid, clear cell,
carcinosarcoma, and mixed pathologies), fallopian tube, or primary peritoneal
cancer that is Stage III or IV according to the International Federation of
Gynecology and Obstetrics or tumor, node and metastasis staging criteria [ie,
American Joint Committee on Cancer].
3. All patients with Stage IV disease are eligible. This includes those with
inoperable disease, those who undergo PDS (CC0 or macroscopic disease), or
those for whom NACT is planned.
4. Patients with Stage III are eligible if they meet one or more of the
following criteria:
a. Stage IIIC patients with CC0 resection if they meet the following criteria:
aggregate >=5 cm extra-pelvic disease during PDS as assessed by the Investigator
b. All patients with inoperable Stage III disease
c. All Stage III patients with macroscopic residual tumor (per Investigator
judgment) following PDS
d. All Stage III patients for whom NACT is planned.
5. Patient must provide a blood sample for ctDNA HRR testing at Pre-Screening
or Screening.
6. Patient must provide sufficient tumor tissue sample (a minimum of 1 FFPE
block or slide at Pre-Screening or Screening for PD-L1, homologous
recombination deficiency HRD testing.
7. Patients of childbearing potential must have a negative serum or urine
pregnancy test (beta human chorionic gonadotropin) within 3 days prior to
receiving the first dose of study treatment.
8. Patients must be postmenopausal, free from menses for >1 year, surgically
sterilized, or willing to use highly effective contraception to prevent
pregnancy or must agree to abstain from activities that could result in
pregnancy throughout the study, starting with enrollment through 180 days after
the last dose of study treatment.
9. Patients must have adequate organ function, defined as follows (Note: CBC
test should be obtained without transfusion or receipt of stimulating factors
within 2 weeks before obtaining Screening blood sample):
a. Absolute neutrophil count >=1,500/µL
b. Platelet count >=100,000/µL
c. Hemoglobin >=9 g/dL
d. Serum creatinine <=1.5 × upper limit of normal (ULN) or calculated creatinine
clearance >=60 mL/min using the Cockcroft-Gault equation
e. Total bilirubin <=1.5 × ULN or direct bilirubin <=1.5 × ULN
f. Aspartate aminotransferase and alanine aminotransferase (ALT) <=2.5 × ULN
unless liver metastases are present, in which case they must be <=5 × ULN
10. Patients must have an ECOG score of 0 or 1.
11. Patients must have normal blood pressure (BP) or adequately treated and
controlled hypertension (systolic BP <=140 mmHg and/or diastolic BP <=90 mmHg).
12. Patients must agree to complete HRQoL questionnaires throughout the study.
13. Patients must be able to take oral medication.
Patients will not be eligible for study entry if any of the following criteria
are met:
1. Patient has mucinous, germ cell, transitional cell, or undifferentiated
tumor.
2. Patient has low grade or Grade 1 epithelial ovarian cancer.
3. Stage III patient with R0 resection after PDS (ie, no macroscopic residual
disease, unless inclusion criterion #4a is met).
4. Patient has not adequately recovered from prior major surgery.
5. 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.
6. Patient is pregnant or is expecting to conceive children while receiving
study drug or for up to 180 days after the last dose of study drug. Patient is
breastfeeding or is expecting to breastfeed within 30 days of receiving the
final dose of study drug (women should not breastfeed or store breastmilk for
use, during niraparib treatment and for 30 days after receiving the final dose
of study treatment).
7. Patient has known active central nervous system metastases, carcinomatous
meningitis, or both.
8. Patient has clinically significant cardiovascular disease (eg, significant
cardiac conduction abnormalities, uncontrolled hypertension, myocardial
infarction, uncontrolled cardiac arrhythmia or unstable angina <6 months to
enrollment, New York Heart Association Grade 2 or greater congestive heart
failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater
peripheral vascular disease, and history of cerebrovascular accident within 6
months).
9. Patient has a bowel obstruction by clinical symptoms or CT scan,
subocclusive mesenteric disease, abdominal or gastrointestinal fistula,
gastrointestinal perforation, or intra abdominal abscess.
10. Patient initiating bevacizumab as SOC has proteinuria as demonstrated by
urine protein:creatinine ratio >=1.0 at Screening or urine dipstick for
proteinuria >=2 (patients discovered to have >=2 proteinuria on dipstick at
baseline should undergo a 24 hour urine collection and must demonstrate <2 g of
protein in 24 hours to be eligible).
11. Patient has any known history or current diagnosis of MDS or AML.
12. 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 noninvasive malignancies such as cervical carcinoma
in situ, ductal carcinoma in situ, Grade 1 or 2, Stage I endometrial cancer, or
non -melanomatous skin cancer are allowed.
13. 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).
14. Patient is immunocompromised. Patients with splenectomy are allowed.
Patients with known human immunodeficiency virus (HIV) are allowed if they meet
all of the following criteria:
a. Cluster of differentiation 4 >=350/µL and viral load
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method