Stage IIIC/IV high-grade ovarian carcinoma ovarian cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Olaparib (150 mg / 100 mg tablet)
INN of investigational material : olaparib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administra
Sponsors
The University of Tokyo Hospital Department of Clinical Genomics
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Provision of informed consent prior to any study specific procedures. 2.Patients must be 20 or > 20 years of age. 3.Female patients with high risk, advanced (FIGO stage IIIC/IV) ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer confirmed by primary surgery (or biopsy). 4. Patients with a initial value (at baseline evaluation) carbohydrate antigen-125 (CA-125) reading of less than 3 times the upper limit of normal (ULN) prior to initiation of study drug administration. 5. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment. 6.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 7.Patients must have a life expectancy 16 or > 16 weeks. 8.Patients who understand that the investigational drug is teratogenic and are able to use contraception during treatment. Postmenopausal or evidence of non-childbearing status for women of childbearing potential. 9.Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. 10. Any olaparib sensitivity-related biomarker study, patients shall meet the following criteria *Consent for genetic research is obtained. *Consent for biomarker study research is obtained. *If a patient refuses to participate in any olaparib sensitivity-related biomarker study, there will be no penalty or loss of benefit to that patient. No patient will be excluded from any other aspect of the study. 11.Patients who have completed first line chemotherapy (taxane and platinum containing therapy) *Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post-treatment scan or a rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum- containing therapy are not eligible for the study. *Platinum based chemotherapy course must have consisted of a minimum of 6 treatment cycles and a maximum of 8. *Patients must not have received bevacizumab during their first line course of treatment, either in combination or as maintenance therapy following combination therapy. *Patients must not have received an investigational drug agent during their first line course of chemotherapy. *Patients must be randomised within 8 weeks after their last dose of chemotherapy (last dose is the day of the last infusion). 12.Biomarker Positive.
Exclusion criteria
Exclusion criteria: Ovarian cancer that is not high grade. Clinically advanced stage is 3B or below. SD or PD to 1st line chemotherapy. Previous treatment with Bevacizumab for ovarian cancer. Biomarker negative.etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy PFS (Progression free survival) Objective radiological disease progression by RECIST (version 1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Efficacy OS PFS2 etc | — |
Countries
Japan
Contacts
Public ContactTetsuya Akiyama
The University of Tokyo Hospital
Outcome results
None listed