Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients in Japan

NCT03063710 | Unknown

• 1 other identifier: D0816L00006
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 2

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 \[known or predicted to be detrimental/lead to loss of function\]) 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.

Conditions

PSR Ovarian Cancer With a BRCA Mutation

Interventions

olaparib DRUG

Initial dose is 300mg twice daily. Study treatment can be dose reduced to 250 mg bd as a first step and to 200 mg bd as a second step. There is no maximum duration for taking study 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.

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Patients must be a permanent resident in Japan and ≥ 18 years of age. For patients aged under 20 years, written informed consent should be obtained both from the patient and his/her legal representative.
• Female patients with histologically diagnosed high grade epithelial ovarian cancer
• Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious from germline or a tumour specimen, prior to provision of informed consent
• Patients who have received at least 2 previous lines of platinum containing therapy prior to assignment to the study
• For the chemotherapy course prior to assignment to the study (except (b)):
• Treatment must have contained a platinum agent
• Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy
• Maintenance treatment is allowed at the end of the penultimate platinum regimen, including bevacizumab
• For the last chemotherapy course immediately prior to assignment to the study
• Patients must be, in the opinion of the investigator as per local standard clinical practice, in response or may have no evidence of disease, and no evidence of a rising CA-125, as defined below, following completion of this chemotherapy course
• Patient must have received a platinum based chemotherapy regimen and have received at least 4 cycles of treatment
• Patients must not have received bevacizumab during this course of treatment
• Patients must not have received any investigational agent during this course of treatment
• Patients must be assigned within 8 weeks of their last dose of chemotherapy

You may not qualify if:

• BRCA1 and/or BRCA2 mutations that are considered to be non detrimental
• Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to assignment to the study
• Previous assignment to the present study
• Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to assignment
• Any previous treatment with a PARP inhibitor, including olaparib
• Patients with a known hypersensitivity to olaparib or any of the excipients of the product
• Resting ECG with QTc \> 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
• Patients receiving any systemic chemotherapy or radiotherapy within 3 weeks prior to study treatment.
• Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors. The required washout period prior to starting study treatment is 2 weeks.
• Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
• Persistent toxicities (\>CTCAE grade 2) caused by previous cancer therapy, excluding alopecia
• Patients with MDS/AML or with features suggestive of MDS/AML.
• Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
• Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
• 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, extensive interstitial bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Akashi-shi, Hyōgo, Japan

Location

Research Site

Chuo-ku, Tokyo, Japan

Location

MeSH Terms

Interventions

olaparib

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

JP (2)