Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03063710
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-05-17
First Post:
2017-02-21
Brief Title:
Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients in Japan
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm open label expanded access program to provide access to olaparib tablets for relapsed high-grade epithelial ovarian cancer patients including patients with primary peritoneal and or fallopian tube cancer with BRCA mutations documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious known or predicted to be detrimentallead to loss of function who have responded following platinum based chemotherapy
Patients may continue to receive study treatment until disease progression as assessed by the investigator according to local standard clinical practice or any other discontinuation criteria are met
Patients may continue to receive study treatment until disease progression as assessed by the investigator according to local standard clinical practice or any other discontinuation criteria are met
Detailed Description:
Primary Objective
To provide expanded access to olaparib tablets for use as maintenance monotherapy in BRCA mutated platinum sensitive relapsed PSR high grade epithelial ovarian cancer patients who are in complete or partial response following platinum based chemotherapy
Secondary Objective
Not applicable
Safety Objective
To collect the individual safety data of olaparib maintenance monotherapy in BRCA mutated PSR high grade epithelial ovarian cancer patients who are in complete or partial response following platinum based chemotherapy
When the number of enrolled patients is not enough 5 patients only listings of safety data will be prepared On the other hand if the number is sufficient 5 patients summaries of safety data will be prepared using descriptive statistics
Target subject population Patients with PSR high-grade epithelial ovarian cancer with a BRCA mutation this includes any patients with primary peritoneal and or fallopian tube cancer At enrollment patients will be in complete or partial response following completion a minimum of 4 treatment cycles of platinum-based chemotherapy
Patients must have completed at least 2 previous lines of platinum-based therapy eg carboplatin or cisplatin before entry to the study and must be considered platinum sensitive after the penultimate platinum-based chemotherapy Platinum sensitive in this study is defined as disease progression greater than 6 months after completion last dose of the penultimate platinum chemotherapy
Patients must not have received bevacizumab during the chemotherapy course immediately prior to entry Cytoreductive surgery prior to the end of the last chemotherapy regimen is allowed as long as it is completed before the end of the chemotherapy regimen
Patients known to have BRCA mutations from germline ie blood or a tumour specimen prior to provision of informed consent can enter the study based on this result The result must be made available to AstraZeneca Patients that have a BRCA mutation identified can enter the study provided that all such testing has been undertaken in appropriately accredited laboratories
Duration of treatment Patients may continue to receive study treatment until disease progression as assessed by the investigator according to local standard clinical practice or any other discontinuation criteria are met
Investigational product dosage and mode of administration Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib Patients will be administered study treatment orally at a dose of 300 mg twice daily The planned dose of 300 mg twice daily will be made up of two x 150 mg tablets twice daily with 100 mg tablets used to manage dose reductions
Statistical methods Approximately 10 patients will be allowed to enter the expanded access program No formal analysis will be performed on any data obtained However all safety data will be summarised and tabulated for regulatory purposes only if the number of enrolled patients is sufficient 5 patients On the other hand if the number of patients is small 5 patients only listings of safety data will be prepared
If the number of enrolled patients is sufficient data summaries will be prepared based on the Safety Analysis Set which will consist of patients who have received at least one dose of olaparib and have at least one post baseline safety assessment
To provide expanded access to olaparib tablets for use as maintenance monotherapy in BRCA mutated platinum sensitive relapsed PSR high grade epithelial ovarian cancer patients who are in complete or partial response following platinum based chemotherapy
Secondary Objective
Not applicable
Safety Objective
To collect the individual safety data of olaparib maintenance monotherapy in BRCA mutated PSR high grade epithelial ovarian cancer patients who are in complete or partial response following platinum based chemotherapy
When the number of enrolled patients is not enough 5 patients only listings of safety data will be prepared On the other hand if the number is sufficient 5 patients summaries of safety data will be prepared using descriptive statistics
Target subject population Patients with PSR high-grade epithelial ovarian cancer with a BRCA mutation this includes any patients with primary peritoneal and or fallopian tube cancer At enrollment patients will be in complete or partial response following completion a minimum of 4 treatment cycles of platinum-based chemotherapy
Patients must have completed at least 2 previous lines of platinum-based therapy eg carboplatin or cisplatin before entry to the study and must be considered platinum sensitive after the penultimate platinum-based chemotherapy Platinum sensitive in this study is defined as disease progression greater than 6 months after completion last dose of the penultimate platinum chemotherapy
Patients must not have received bevacizumab during the chemotherapy course immediately prior to entry Cytoreductive surgery prior to the end of the last chemotherapy regimen is allowed as long as it is completed before the end of the chemotherapy regimen
Patients known to have BRCA mutations from germline ie blood or a tumour specimen prior to provision of informed consent can enter the study based on this result The result must be made available to AstraZeneca Patients that have a BRCA mutation identified can enter the study provided that all such testing has been undertaken in appropriately accredited laboratories
Duration of treatment Patients may continue to receive study treatment until disease progression as assessed by the investigator according to local standard clinical practice or any other discontinuation criteria are met
Investigational product dosage and mode of administration Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib Patients will be administered study treatment orally at a dose of 300 mg twice daily The planned dose of 300 mg twice daily will be made up of two x 150 mg tablets twice daily with 100 mg tablets used to manage dose reductions
Statistical methods Approximately 10 patients will be allowed to enter the expanded access program No formal analysis will be performed on any data obtained However all safety data will be summarised and tabulated for regulatory purposes only if the number of enrolled patients is sufficient 5 patients On the other hand if the number of patients is small 5 patients only listings of safety data will be prepared
If the number of enrolled patients is sufficient data summaries will be prepared based on the Safety Analysis Set which will consist of patients who have received at least one dose of olaparib and have at least one post baseline safety assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None