A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
- Conditions
- Platinum Sensitive Ovarian CancerMedDRA version: 20.0Level: 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-SE
- Lead Sponsor
- TESARO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 490
1. Female, age at least 18 years
2. Patient agrees to undergo analysis of their gBRCA status. (Testing must be completed prior to randomization. The sample may be submitted at any time prior to the screening period if it appears patient is likely to meet other eligibility requirements. To facilitate early testing, a separate informed consent form [ICF] specific for genotyping will be available to
be signed prior to gBRCA status testing.)
3. Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
4. High grade (or Grade 3) serous or high grade predominantly serous histology or known to have gBRCAmut
5. Patients must have completed at least 2 previous courses of platinum- containing therapy (eg, 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 disease progression > 6 months after completion of their last dose of platinum therapy (document 6-12 months or > 12 months). (Source documentation required and may include physician or clinic notes.)
b. For the last chemotherapy course prior to being randomized in 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. CA-125 in the normal range OR
2. CA-125 decrease by more than 90% during their last platinum regimen which is stable for at least 7 days (ie, no increase > 15%) iv. Following the last regimen, patients must not have any measurable lesion > 2 cm at the time of study entry
c. Patients must be randomized within 8 weeks after completion of their final dose of the platinum-containing regimen.
Note: The last platinum regimen does not necessarily have to immediately follow the next to last (penultimate) platinum regimen. For example, if a patient received a non-platinum regimen between the penultimate platinum regimen and last platinum regimen, they could be eligible, so long as they meet all entry criteria
6. The patient agrees to complete PROs during study treatment and at 1 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 patients
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
9. Adequate organ function
a. Absolute neutrophil count (ANC) = 1,500/µL
b. Platelets = 100,000/µL
c. Hemoglobin = 9 g/dL
d. Serum creatinine = 1.5 x upper limit of normal (ULN) or calculated creatinine clearance = 60 mL/min using Cockcroft-Gault equation
e. Total bilirubin = 1.5 x ULN OR direct bilirubin = 1 x ULN
f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN unless liver metastases are present, in which case they must be = 5 x 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 inclusio
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. (To be considered controlled, central nervous system (CNS) disease must have undergone treatment [eg, radiation or chemotherapy] at least 1 month prior to study entry. The patient must not have any new or progressive signs or symptoms related to the CNS disease and must be taking a stable dose of steroids or no steroids.) A scan to confirm the absence of brainmetastases 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 (SD) 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 = 2 years prior to randomization (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 90 days) 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
• Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment
10. Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the study treatment
11. Immunocompromised patients (Note: patients with splenectomy are allowed.)
12. Patients with known active hepatic disease (ie, Hepatitis B or C)
13. Prior treatment with a known PARP inhibitor
14. Patients with a baseline QT prolongation > 470 milliseconds
15. Patients are receiving concomitant medications that prolong QTc and are unable to discontinue use for the duration of the study
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 FE sub-study 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