The Clinical Markers for PARP Inhibitors-related Efficacy in Ovarian Cancer

• Conditions: Ovarian Cancer; Clinical Marker; PARP Inhibitor
• Interventions: Drug: PARP inhibitors

• Registration Number: NCT04582552
• Lead Sponsor: Xiaoxiang Chen

Brief Summary

Epithelial ovarian cancer (EOC) is the most lethal gynecological malignancy. PARP inhibitors(PARPi) are an important progress in EOC treatment. The available evidence suggests that BRCAmt or HRD-positive is an effective biological marker for PARPi. However, in our previous clinical observation, it was found that the tumor burden may be the potential clinical markers PARPi. We intend to develop a real-world study to confirm the potential clinical markers and explore new clinical markers for PARPi.

Detailed Description

This study intends to conduct a systematic real-world study to observe the relationship between the clinical characteristics of EOC patients and the efficacy of PARPi based on our existing research foundation and stratified analyse these correlations by BRCA and HRD status.

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-09
• Study Start: 2020-12-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-20
• Primary Completion: 2022-05
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Subjects join the study voluntarily and sign informed consent;
2. Female subjects are older than 18 years;
3. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
4. Life expectancy≥3 months;
5. Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous or endometrioid histology;
6. Patients should test for BRCA gene and will perform test for HRD status if who harbor BRCAwt in the same laboratory designated by the researcher;
7. Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.

Exclusion Criteria

1. Personnel involved in the formulation or implementation of the research plan;
2. Patient participated in other clinical trails using other experimental drugs at the same time as the study;
3. The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;
4. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
5. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ovarian cancer patients treated with PARP inhibitors	PARP inhibitors	PARP inhibitors therapy until disease progression

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Through study completion, an average of 1 year	ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.
Progression Free Survival (PFS)	Through study completion, an average of 1 year	PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1.
Duration of Response (DOR)	Through study completion, an average of 1 year	DOR is defined as the time from the first date of response until the date of first documented progression.
Disease Control Rate (DCR)	Through study completion, an average of 1 year	DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.
Adverse events (AEs)	Through study completion, an average of 1 year	Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 to further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants.

Trial Locations

Locations (1)

Xiaoxiang Chen, MD,PhD; 🇨🇳 Nanjing, Jiangsu, China