PSR Ovarian Cancer With a BRCA Mutation Clinical Trial
Official title:
Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients
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 detrimental/lead 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.
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:
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 (e.g.,
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 mutation/s from germline (i.e., 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.
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