Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting

NCT04284852 | Completed Phase 2

• 1 other identifier: UW-19-681
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of niraparib in those who have received neoadjuvant chemotherapy and subsequent interval debulking surgery, with or without hyperthermic intraperitoneal chemotherapy, and would also explore if there are any biomarkers, other than BRCA / HRD status and platinum sensitivity, that may help to identify those who may benefit from PARPi especially those who are HRD negative.

Conditions

Ovarian Cancer

Keywords

advanced; ovarian; cancer; neoadjuvant; niraparib

Outcome Measures

Primary Outcomes (1)

• PFS rate at 18 months

  Proportion of patients who are progression-free at 18 months according to the RECIST 1.1

  up to 18 months

Secondary Outcomes (5)

• PFS by the RECIST 1.1

  up to 5 years

• Overall survival

  up to 5 years

• OS rate at 18 months

  up to 18 months

• Change of biomarkers

  up to 18 months

• Treatment-related adverse events

  up to 18 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

Niraparib 200 or 300mg daily orally for 18 cycles unless disease progression or intolerable side effects (whichever occurs first)

Drug: Niraparib

Interventions

Niraparib DRUG

PARP inhibitor

Also known as: Zejula

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at least 18 years old.
• Patients must have newly diagnosed, histologically confirmed high grade, serous or endometrioid, FIGO stage 3 or 4, ovarian, fallopian tube or primary peritoneal carcinoma before the start of NACT.
• Patients must have received 3 - 4 cycles of NACT containing either carboplatin or cisplatin, IDS with or without HIPEC, and 3 - 6 more cycles of adjuvant chemotherapy, prior to recruitment into the study.
• The patients should have only one cytoreductive surgery.
• The patients must show either complete (CR) or partial response (PR) to the platinum-based chemotherapy using RECIST 1.1 criteria.
• Patients should not be amenable to further surgery or radiotherapy except for the purpose of symptomatic relief.
• All surgery, chemotherapy and radiotherapy should finish more than 3 weeks prior to recruitment.
• Niraparib should be started within 8 weeks after the last dose of chemotherapy.
• Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
• Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.
• Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment.

You may not qualify if:

• Patients who are diagnosed to have low-grade or borderline carcinoma, mucinous or clear cell cystadenocarcinoma, carcinosarcoma or undifferentiated carcinoma, are excluded.
• Patients who have stable disease or PD on the post-treatment scan or clinical evidence are excluded.
• Patients who have drainage of ascites within 4 weeks before recruitment are excluded.
• Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer or in-situ breast cancer) are excluded.
• Patients who have history of unresolved thrombocytopenia, myelodysplastic syndrome or acute myeloid leukaemia are excluded.
• Patients who have symptomatic brain or leptomeningeal metastases, or spinal cord compression are excluded unless these are treated and controlled within 28 days of recruitment.
• Patients with the significant past medical history, such as active hepatitis, myocardiac infarction, in the last six months are excluded.
• Patients with severe gastrointestinal conditions such as evidence of bowel obstruction in the last 4 weeks prior to enrolment, or history of inflammatory bowel disease, are not eligible.
• Patients having had severe infections within 4 weeks prior to the start of treatment are excluded.
• Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.
• Patients with prior allogeneic stem cell or solid organ transplantation are excluded.
• Those patients who suffer from CTCAE grade 2 or more toxicity from previous treatment, except alopecia, are excluded.
• Patients who have used PARPi previously are excluded.
• Patients who are allergic to any component of niraparib are excluded.
• Patients who have used bevacizumab, or who are going to use bevacizumab as maintenance, are not eligible to join the study.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; 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

Study Officials

• Ka Yu Tse, FRCOG

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 26, 2020
• Study Start: May 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)