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

NCT04582552 | Unknown

• 1 other identifier: JiangsuCH
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Clinical Marker; PARP Inhibitor

Keywords

Ovarian caner, PARP inhibitor, Clinical marker

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Ovarian cancer patients treated with PARP inhibitors

PARP inhibitors therapy until disease progression

Drug: PARP inhibitors

Interventions

PARP inhibitors DRUG

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

Also known as: Lynparza, Zejula

Ovarian cancer patients treated with PARP inhibitors

Eligibility Criteria

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

Study Population

Ovarian cancer patients treated with PARP inhibitor in the real word.

You may qualify if:

• Subjects join the study voluntarily and sign informed consent;
• Female subjects are older than 18 years;
• ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
• Life expectancy≥3 months;
• 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;
• 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;
• Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.

You may not qualify if:

• Personnel involved in the formulation or implementation of the research plan;
• Patient participated in other clinical trails using other experimental drugs at the same time as the study;
• 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;
• Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
• Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.

Sponsors & Collaborators

• Xiaoxiang Chen: lead

Study Sites (1)

Xiaoxiang Chen, MD,PhD

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Poly(ADP-ribose) Polymerase Inhibitors; olaparib; niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Xiaoxiang Chen, MD,PhD

  Jiangsu Cancer Institute & Hospital

  STUDY CHAIR

• Jing Ni, MD

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Ni, MD

CONTACT

+86 13327833586; nijingwulin@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Academic secretary of gynecological oncology Committee of Jiangsu anti cancer association

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 9, 2020
• Study Start: December 15, 2020
• Primary Completion: May 1, 2022
• Study Completion: November 1, 2023
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)