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Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting (NEOPRIMA)

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ClinicalTrials.gov Identifier: NCT04284852
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : September 29, 2021
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Niraparib Phase 2

Detailed Description:
Despite cytoreductive surgery and platinum-based chemotherapy, about 70% of patients with advanced ovarian cancer recur in the first 2 - 3 years. PARPi has been shown to be prolong survival in primary advanced ovarian cancer. However its role in neoadjuvant setting has not been fully evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting - a Phase 2, Single-arm Trial (NEOPRIMA Trial)
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Arm Intervention/treatment
Experimental: Experimental arm
Niraparib 200 or 300mg daily orally for 18 cycles unless disease progression or intolerable side effects (whichever occurs first)
Drug: Niraparib
PARP inhibitor
Other Name: Zejula

Primary Outcome Measures :
  1. PFS rate at 18 months [ Time Frame: up to 18 months ]
    Proportion of patients who are progression-free at 18 months according to the RECIST 1.1

Secondary Outcome Measures :
  1. PFS by the RECIST 1.1 [ Time Frame: up to 5 years ]
    The time from first dose of trial medication to first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first.

  2. Overall survival [ Time Frame: up to 5 years ]
    Overall survival is defined as the time from first dose of trial medication to date of death due to any cause.

  3. OS rate at 18 months [ Time Frame: up to 18 months ]
    Proportion of patients who are alive at 18 months

  4. Change of biomarkers [ Time Frame: up to 18 months ]
    Expression levels of markers like Ki-67 before and after chemotherapy

  5. Treatment-related adverse events [ Time Frame: up to 18 months ]
    Incidence of treatment-related adverse events classified by CTCAE version 5.0

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must be at least 18 years old.
  2. 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.
  3. 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.
  4. The patients should have only one cytoreductive surgery.
  5. The patients must show either complete (CR) or partial response (PR) to the platinum-based chemotherapy using RECIST 1.1 criteria.
  6. Patients should not be amenable to further surgery or radiotherapy except for the purpose of symptomatic relief.
  7. All surgery, chemotherapy and radiotherapy should finish more than 3 weeks prior to recruitment.
  8. Niraparib should be started within 8 weeks after the last dose of chemotherapy.
  9. Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
  10. Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.
  11. Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment.

Exclusion Criteria:

  1. Patients who are diagnosed to have low-grade or borderline carcinoma, mucinous or clear cell cystadenocarcinoma, carcinosarcoma or undifferentiated carcinoma, are excluded.
  2. Patients who have stable disease or PD on the post-treatment scan or clinical evidence are excluded.
  3. Patients who have drainage of ascites within 4 weeks before recruitment are excluded.
  4. Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer or in-situ breast cancer) are excluded.
  5. Patients who have history of unresolved thrombocytopenia, myelodysplastic syndrome or acute myeloid leukaemia are excluded.
  6. 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.
  7. Patients with the significant past medical history, such as active hepatitis, myocardiac infarction, in the last six months are excluded.
  8. 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.
  9. Patients having had severe infections within 4 weeks prior to the start of treatment are excluded.
  10. Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.
  11. Patients with prior allogeneic stem cell or solid organ transplantation are excluded.
  12. Those patients who suffer from CTCAE grade 2 or more toxicity from previous treatment, except alopecia, are excluded.
  13. Patients who have used PARPi previously are excluded.
  14. Patients who are allergic to any component of niraparib are excluded.
  15. Patients who have used bevacizumab, or who are going to use bevacizumab as maintenance, are not eligible to join the study.
  16. Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is longer) before study drug administration is not allowed.
  17. Patients who are pregnant or breastfeeding are excluded.
  18. Patients must not have either platelet or red blood cell transfusion, or granulocyte colony stimulating factor (G-CSF) within 2 weeks of the first dose of study treatment.
  19. Patients must not plan to donate blood during the study or for 90 days after the last dose of study treatment.
  20. Patients with major operation within 28 days or open biopsy within 7 days before enrolment are not eligible.
  21. Patients planned to have major surgery during the course of the study are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04284852

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Contact: Ka Yu Tse, FRCOG 852-22554518 tseky@hku.hk

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Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Tina Wei    852-22554265    tinawei@hku.hk   
Contact: Lesley Lau    852-22554265    lsk382@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
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Principal Investigator: Ka Yu Tse, FRCOG The University of Hong Kong
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04284852    
Other Study ID Numbers: UW-19-681
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong:
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents