Efficacy and Safety of Niraparib Combined With Oral Etoposide in Platinum Resistant/Refractory Recurrent Ovarian Cancer

NCT04217798 | Unknown Phase 2

• 1 other identifier: CH1902001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the efficacy and safety of niraparib combined with oral etoposide in platinum resistant or platinum refractory recurrent ovarian cancer.

Conditions

Ovarian Cancer

Keywords

platinum resistent/refractory, ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as the time from randomization to first disease progression by investigator assessment using RECIST 1.1 or death, from any cause, whichever comes first.

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Through study completion, an average of 1 year

• Duration of Response (DOR)

  Through study completion, an average of 1 year

• Disease Control Rate (DCR)

  Through study completion, an average of 1 year

• CA125 Response Rate

  Through study completion, an average of 1 year

• The frequency and severity of adverse events

  Through study completion, an average of 1 year

Study Arms (1)

Niparib combined with oral etoposide

EXPERIMENTAL

Subjects will received niraparib 200mg or 100mg alternate once daily and oral etoposide 50mg on day 1-20 of a 30-day cycle. Oral etoposide was administered for a maximum of 6-8 cycles. Treatment was continued until disease progression, patient withdrawal or unacceptable toxic effects.

Drug: Niraparib

Interventions

Niraparib DRUG

Subjects will receive niraparib combined with oral etoposide (on day 1-20, every 30 days). After 6-8 cycles, oral etoposide will be terminated. Niraparib will be still given to subjects until disease progression, intolerable toxicity or withdrawal of informed consent.

Also known as: oral etoposide

Niparib combined with oral etoposide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent before undertaking any study procedure.
• Female, age 18-70.
• Histologically confirmed FIGO stage III or IV non-mucinous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• No limitation of the BRCA mutation and HRD status.
• Platinum resistant or refractory recurrent disease.
• Subjects must have received at least 1 prior line of platinum-based chemotherapy regimen and no more than twice.
• Subjects must have measurable lesions with imaging evidence of disease progression (according to RECIST1.1 criteria); or without measurable/evaluable lesion (RECIST 1.1 criteria), but two consecutive cases of elevated CA125 \> 2 times the upper limit of normal (\> 70 U/ml) were detected.
• Life expectancy of more than 6 months.
• ECOG 0-1.
• Good organ function, including:
• Bone marrow function: neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥10 g/dL;
• Hepatic function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or direct bilirubin ≤1.0 x ULN, AST and ALT ≤2.5 x ULN unless liver metastases are present, in which case they must be ≤5 x ULN;
• Renal function: serum creatinine ≤1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation.
• Has a negative serum pregnancy test within 3 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 3 months after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):
• ≥45 years and \<60 years of age and has not had menses for \>1 year

You may not qualify if:

• Has a known hypersensitivity to the active or inactive ingredients of niraparib or compound which has similar chemical structure to niraparib.
• Has a known hypersensitivity to the active or inactive ingredients of etoposide or compound which has similar chemical structure to etoposide.
• prior PARP inhibitor therapy.
• Has symptomatic uncontrolled brain or leptomeningeal metastasis.
• Major surgery or chemotherapy within 3 weeks of starting the study or patient has not recovered from any effects of the surgery.
• Receive palliative radiotherapy encompassing \> 20% of the bone marrow within 1 week of entering the study.
• Be diagnosed any invasive cancer other than ovarian cancer (apart from cured basal cell carcinoma and squamous cell carcinoma) within 2 years prior to study enrolment.
• Previously or currently diagnosed of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
• Has other serious or uncontrolled disease.
• Has any disease, treatment and laboratory abnormality that may interfere the study results and affect the fully attendance of study. Or the subject is considered to be not suitable for the study by the investigator. Cannot receive platelet or red blood cell transfusion within 4 weeks of study drug administration.
• Pregnant, breastfeeding or expecting to conceive children during the study treatment period.
• Adjusted for QT interval (QTc) \>470 msec.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Zai Lab (Shanghai) Co., Ltd.: collaborator

Study Sites (2)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Shandong Cancer Hospital

Jinan, China

RECRUITING

Related Publications (1)

• Zhou H, Liu Q, Zhang D, Li Q, Cao D, Cheng N, Wan X, Zhang Y, Feng F, Xiang Y, Yang J. Efficacy and safety of an oral combination therapy of niraparib and etoposide in platinum resistant/refractory ovarian cancer: a single arm, prospective, phase II study. Int J Gynecol Cancer. 2024 Nov 4;34(11):1761-1767. doi: 10.1136/ijgc-2024-005386.

  PMID: 39074931 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib; Etoposide

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)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Jiaxin Yang, MD

CONTACT

13661160998; yangjiaxin@pumch.cn

HuiMei Zhou, MD

CONTACT

18600012090; mayflower0808@126.com

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: December 9, 2019
• First Posted: January 3, 2020
• Study Start: May 21, 2020
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 1, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)