D
- Conditions
- Platinum Sensitive Ovarian CancerMedDRA version: 16.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000685-11-IT
- Lead Sponsor
- TESARO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 360
1. Female, age at least 18 years
2. Patient agrees to undergo analysis of their germline BRCA status. (Testing mustbe completed prior to randomization with sample submitted up to 3 months prior to randomization if it appears patient is likely to meet other eligibility requirements.)
3. Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
4. High grade (or grade 3) serous histology or known to have gBRCAmut
5. Patients must have completed at least 2 previous courses of platinum-containing therapy (e.g. carboplatin, oxaliplatin or cisplatin):
a. For the penultimate (next to last) platinum based chemotherapy course prior to enrollment on the study:
i. A patient must have platinum sensitive disease after this treatment; defined as achieving a response (CR or PR) and having a chemotherapy-free interval of =6 months (document 6-12m or
>12m). Chemotherapy-free interval is defined as the time from last dose of platinum until initiation of subsequent therapeutic chemotherapy (excluding maintenance therapy; source documentation required and may include physician or clinic notes)
b. For the last chemotherapy course prior to enrollment on the study:
i. Patients must have received a platinum-containing regimen for a minimum of 4 cycles
ii. Patients must have achieved a partial or complete tumor response.
iii. Following the last regimen, patients must have either
1. CA125 in the normal range OR
2. CA125 decrease by more than 90% during their last platinum regimen which is stable for at least 7 days (i.e., no increase >15%)
iv. Following the last regimen, patients must have no measurable disease >2cm at the time of study entry
c. Patients must be started on study treatment between 3 and 8 weeks after completion of their final dose of the platinum-containing regimen.
6. The patient agrees to complete PROs during study treatment AND one additional time point 8 weeks following study treatment discontinuation. It is estimated that completion of PROs will take less than 20 minutes at each time point. Since these are questionnaires, their completion will not interfere with, or preclude, future treatment or clinical studies.
7. Formalin fixed, paraffin embedded archival tumor available from the primary or recurrent cancer required for all non-gBRCAmut patients (and strongly encouraged for gBRCAmut patients).
8. ECOG performance status 0-1.
9. Adequate organ function
a. Absolute neutrophil count (ANC) =1,500/mcL
b. Platelets =100,000/mcL
c. Hemoglobin =9g/dL
d. Serum creatinine =1.5x upper limit of normal (ULN) or calculated creatinine clearance =60mL/min using Cockcroft-Gault equation
e. Total bilirubin =1.5x ULN OR direct bilirubin = 1x ULN
f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5x ULN unless liver metastases are present, in which case they must be =5x ULN
10. Able to take oral medications
11. Women of childbearing potential must use adequate birth control for the duration of study participation.
Additional Inclusion Criteria for Food Effect Sub Study:
With the exception of inclusion criteria 2, 4, 5, 6, 7 and 8 (above), all main study inclusion criteria apply. In addition, the following inclusion criteria apply to the food effect sub-study only:
1. Entry criteria are broadened to include patients with ovarian cancer regardless of platinum sensitivity and burden of disease as long as no standard therapy exists or the patient has refused standard therapy.
2. ECOG 0-2.
3. Must be able
1. Drainage of ascites during last 2 cycles of last chemotherapy.
2. Palliative radiotherapy within 1 week encompassing >20% of the bone marrow.
3. Persistent > grade 2 toxicity from prior cancer therapy.
4. Symptomatic uncontrolled brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically stable disease for 28 days.
5. Known hypersensitivity to the components of niraparib.
6. Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery.
7. Diagnosis, detection or treatment of invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitively treated).
8. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
9. History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient‘s participation for the full duration of the study treatment, or is not in the best interest of the patient to participate.
10. Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the study treatment.
11. Immunocompromised patients.
12. Patients with known active hepatic disease (i.e. , Hepatitis B or C).
13. Prior treatment with a known or putative PARP inhibitor.
Additional Exclusion Criteria for Food Effect Sub-Study:
With the exception of exclusion criteria 1 and 13 (above), all main study exclusion criteria apply. In addition, the following exclusion criteria apply to the food effect substudy only:
1. Chemotherapy within 3 weeks of study start.
2. Patient taking a proton pump inhibitor, antacids, or H2 blocker within 48 hours of dose.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method