Olaparib (LYNPARZA) maintenance re-administration in Japanese women with platinum-sensitive recurrent ovarian cancer

JRCT ID: jRCT1061230030

Registered date:27/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Epithelial ovarian cancer / fallopian tube cancer / peritoneal cancer
• Date of first enrollment: 17/08/2023
• Target sample size: 57
• Study type: Observational

Outcome(s)

• Primary Outcome: Progression-free survival rate at 1 year

Secondary Outcome

1 PFS
2 Time to first subsequent treatment commencement (TFST)
3 Time to second objective disease progression (PFS2)
4 Time to second subsequent treatment commencement (TSST)
5 1-year overall survival (OS) rate
6 AE evaluated in CTC-AE version 5.0, type, severity and frequency of occurrence

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

Patients must meet the following criteria for study entry:
1) Patients aged 18 or above.
2) Histopathologically diagnosed epithelial ovarian (non-mucinous), fallopian tube, or peritoneal cancer (histological examination at recurrence or relapse is not required).
3) Confirmed positive germline BRCA pathological variants or positive tumor tissue BRCA pathological variants or positive HRD.
4) Received maintenance therapy with a PARP inhibitor (olaparib or niraparib) after initial chemotherapy including platinum-based agents (including patients who received maintenance therapy with the combination of bevacizumab and olaparib).
5) Patients with a history of two regimens of chemotherapy containing platinum-based agents, and the most recent chemotherapy includes a platinum-based agent (if there was a regimen change due to allergies, it should be counted as a consecutive regimen).
6) The period from the final administration of platinum-based agents in the initial chemotherapy to the diagnosis of recurrence or relapse is 6 months or longer.
7) Patients who have shown efficacy in the most recent chemotherapy containing platinum-based agents (evaluated as partial response or complete response according to RECIST version 1.1).
8) Scheduled to undergo maintenance therapy with olaparib after second-line chemotherapy containing platinum-based agents.
9) Patients who, after receiving sufficient explanation, have a thorough understanding and are able to provide written informed consent based on their own free will for participation in this study.

Exclude criteria

Patients who meet any of the following criteria will be excluded from study entry:
1) Patients with a history of three or more lines of chemotherapy containing platinum-based agents.
2) Patients who received concurrent administration of bevacizumab in the most recent chemotherapy containing platinum-based agents.
3) Patients with a history of radiation therapy, hormone therapy, or immunotherapy for ovarian cancer.
4) Patients with a general condition (ECOG Performance Status) of 3 or higher.
5) Patients with metastases to the central nervous system.
6) Patients with severe complications.
7) Patients with active concurrent malignancies.
8) Patients with a history of myelodysplastic syndrome, acute myeloid leukemia, or other secondary malignancies believed to be caused by PARP inhibitors.
9) Patients with a history of allergy to PARP inhibitors.
10) Patients who are positive for HBs antigen or HBc antigen, or patients who are positive for HCV antibodies and HCV RNA in serum and are carriers of hepatitis.
11) Other patients deemed inappropriate as study subjects by the principal investigator or study collaborators.

Related Information

• Primary Sponsor: Nagao Shoji
• Secondary Sponsor: AstraZeneca K.K.