To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer (ORZORA)
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|ClinicalTrials.gov Identifier: NCT02476968|
Recruitment Status : Active, not recruiting
First Posted : June 22, 2015
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|BRCA or HRR+ Mutated Ovarian Cancer Patients||Drug: Olaparib||Phase 4|
The study will recruit approximately 250 patients with sBRCAm disease or gBRCAm disease, with the aim to accrue a minimum of 50 patients with sBRCAm disease.
Patients with an unknown germline BRCA mutated status or gBRCAwt disease or previously identified as having a BRCAm disease by a tumour test will be considered for screening and will undergo, upon informed consent signature, central tumor and blood testing to determine their BRCA mutation status. In addition to central BRCA testing, patients screened for the study with unknown BRCA status or with known gBRCAwt status, for whom an adequate archival tumour tissue sample is available, will be tested for qualifying HRR gene alterations. Patients confirmed to carry a deleterious or suspected deleterious BRCA-independent genetic alteration in any of 13 genes involved in the Homologous Recombination Repair (HRR) pathway (HRRm cohort) will be allowed into an additional exploratory cohort (HRRm cohort). It is expected that approximately 25 patients will be included in the HRRm cohort before the target number of 250 patients with BRCAm disease is reached.
Patients will be assigned olaparib capsules orally 400 mg twice daily. They should initiate olaparib treatment within 8 weeks after their last dose of platinum-containing chemotherapy (last dose is the day of the last infusion) and will be assessed every 4 weeks whilst on treatment.
All patients will have clinical and objective radiological tumour assessments according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines at baseline and every 12 weeks relative to date of enrolment, until objective radiological disease progression as determined by the investigator. Patients could continue to receive olaparib for as long as determined by the investigator, until objective radiological disease progression or as long as in the investigator's opinion they are benefiting from treatment in relation to other clinical assessments and they do not meet any other discontinuation criteria. Once a patient has discontinued olaparib she will be managed as per local clinical practice but will remain in the study and data will be collected on subsequent treatments, progression, overall survival and safety.
For exploratory analysis purposes, patients will be asked to provide consent to:
- Optional tumour samples at baseline and at disease progression
- An optional blood sample only for patients with a confirmed sBRCAm or HRRm disease
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||178 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Single Arm, Multicentre Study to Assess the Clinical Effectiveness and Safety of Lynparza (Olaparib) Capsules Maintenance Monotherapy in Platinum Sensitive Relapsed Somatic or Germline BRCA Mutated Ovarian Cancer Patients Who Are in Complete or Partial Response Following Platinum Based Chemotherapy (ORZORA).|
|Actual Study Start Date :||September 28, 2015|
|Estimated Primary Completion Date :||October 24, 2019|
|Estimated Study Completion Date :||October 24, 2019|
Open Label Drug
Olaparib Capsule - 50 mg. Olaparib capsules will be packed in high-density polyethylene (HDPE) bottles with child-resistant closures. Each bottle will contain 120 capsules and 4 bottles will be dispensed for a 4 weekly visit, with a 2 day overage.
Patients will be administered olaparib capsules orally at a dose of 400 mg twice daily.
Eight 50 mg olaparib capsules should be taken at the same time each day approximately 12 hours apart with approximately 240 mL of water.
Other Name: Lynparza
- Time from study enrolment to disease progression (assessed according to RECIST 1.1 guidelines) or death. [ Time Frame: Time from first patient enrolled to data cut off (up to 32 months) assessed approximately every 12 weeks ]
- To assess the real world clinical effectiveness of olaparib maintenance monotherapy by investigator assessed progression free survival (PFS) according to modified Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 in patients with sBRCAm ovarian cancer.
- To assess the real world clinical effectiveness of olaparib maintenance monotherapy by investigator assessed PFS according to RECIST 1.1 in patients with BRCAm ovarian cancer.
- Time to death and Time to second progression event or death if this occurs before second progression event. [ Time Frame: Time from first patient enrolled to data cut off (up to 32 months) ]
To assess the real world clinical effectiveness of olaparib maintenance monotherapy in patients with BRCAm ovarian cancer and patients with sBRCAm ovarian cancer, by assessment of:
- Overall survival,
- Time to investigator-assessed second progression or death.
- Time to first and second treatment commencement or death and time to olaparib discontinuation or death. [ Time Frame: Time from first patient enrolled to first & second treatment commencement or death and time to olaparib discontinuation or death analysed at data cut off (up to 32 months) ]
To assess the real world clinical effectiveness of olaparib maintenance monotherapy in patients with BRCAm ovarian cancer and patients with sBRCAm ovarian cancer, by assessment of :
- time to first subsequent therapy or death,
- time to second subsequent therapy or death and,
- time to olaparib discontinuation or death.
- Functional Assessment of Cancer Therapy-Ovarian (FACT-O), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, and ORZORA QoL Additional Items Questionnaire [ Time Frame: Time from first patient enrolled to 24 months or the data cut off for the primary analysis, whichever comes first. ]To assess and describe the quality of life (QoL) of patients with BRCAm ovarian cancer and patients with sBRCAm ovarian cancer.
- Safety summary tables, Functional Living Index-Emesis (FLIE) Questionnaire, and concomitant medication use. [ Time Frame: Time from first patient enrolled to 24 months or the data cut off for the primary analysis, whichever comes first. ]
To describe patterns of routine clinical use of olaparib, the nature and patterns of adverse events (AEs) of nausea and vomiting and their impact on QoL in patients with BRCAm ovarian cancer and patients with sBRCAm ovarian cancer.
To describe nausea/vomiting toxicity management patterns used in routine clinical practice.
- AEs/Serious adverse events (SAEs)/AE of special interest (AESI) [ Time Frame: From time of signature of informed consent to 30 days after last dose ]To assess the safety and tolerability of olaparib maintenance monotherapy in patients with BRCAm ovarian cancer and patients with sBRCAm ovarian cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476968
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|Principal Investigator:||Sandro Pignata, Doctor of Medicine||Istituto Nazionale Tumori Fondazione G. Pascale, 80131, Napoli, Italy|