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

Ovarian Cancer Clinical Trial

— ROMP  

Official title:

A Real-world Study of Clinical Markers for PARP Inhibitors in Epithelial Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04582552
• Other study ID #: JiangsuCH
• Status: Recruiting
• Start date: December 15, 2020
• Est. completion date: November 2023

Study information

• Verified date: January 2021
• Source: Jiangsu Cancer Hospital (Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital)
• Contact: Jing Ni, MD
• Phone: +86 13327833586
• Email: nijingwulin[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2023
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Clinical Marker
• Ovarian Cancer
• Ovarian Neoplasms
• PARP Inhibitor

Intervention

Drug:
• PARP inhibitors
Ovarian cancer patients with PARP inhibitors according to the NCCN guideline and their instructions.

Locations

Country	Name	City	State
China	Xiaoxiang Chen, MD,PhD	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoxiang Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.	Through study completion, an average of 1 year
Primary	Progression Free Survival (PFS)	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.	Through study completion, an average of 1 year
Primary	Duration of Response (DOR)	DOR is defined as the time from the first date of response until the date of first documented progression.	Through study completion, an average of 1 year
Primary	Disease Control Rate (DCR)	DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.	Through study completion, an average of 1 year
Primary	Adverse events (AEs)	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.	Through study completion, an average of 1 year