- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04217798
Efficacy and Safety of Niraparib Combined With Oral Etoposide in Platinum Resistant/Refractory Recurrent Ovarian Cancer
A Single Arm, Prospective, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Niraparib Combined With Oral Etoposide in Platinum Resistant/ Refractory Recurrent Ovarian Cancer
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jiaxin Yang, MD
- Phone Number: 13661160998
- Email: yangjiaxin@pumch.cn
Study Contact Backup
- Name: HuiMei Zhou, MD
- Phone Number: 18600012090
- Email: mayflower0808@126.com
Study Locations
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-
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Beijing, China
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- HuiMei Zhou
- Phone Number: 18600012090 18600012090
- Email: mayflower0808@126.com
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Jinan, China
- Recruiting
- Shandong Cancer Hospital
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Contact:
- Depu Zhang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- ≥60 years of age
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.
- Is able to adhere to the protocol.
- Has recovered from previous chemotherapy induced toxic side effects to ≤ grade 1 CTCAE or basal level, apart from ≤ grade 2 CTCAE peripheral neuropathy or hair loss symptoms at steady state.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Niparib combined with oral etoposide
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: Through study completion, an average of 1 year
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Response (DOR)
Time Frame: Through study completion, an average of 1 year
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DOR is defined as the time from the first date of response until the date of first documented progression.
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Through study completion, an average of 1 year
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Objective Response Rate (ORR)
Time Frame: Through study completion, an average of 1 year
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ORR is defined as the proportion of subjects who have a partial response (PR) or complete response (CR) to therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
|
Through study completion, an average of 1 year
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Disease Control Rate (DCR)
Time Frame: Through study completion, an average of 1 year
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DCR is defined as the proportion of subjects who have a complete response (CR), partial response (PR) and stable disease (SD) to therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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Through study completion, an average of 1 year
|
CA125 Response Rate
Time Frame: Through study completion, an average of 1 year
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The proportion of subjects with a minimum 50% reduction in CA-125 serum levels lasting for ≥28 days relative to baseline CA-125 serum levels.
|
Through study completion, an average of 1 year
|
The frequency and severity of adverse events
Time Frame: Through study completion, an average of 1 year
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The frequency and severity of adverse events evaluated according to NCI CTCAE version 5.0 during subjects receiving the study treatment.
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Through study completion, an average of 1 year
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Poly(ADP-ribose) Polymerase Inhibitors
- Etoposide
- Niraparib
Other Study ID Numbers
- CH1902001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Clinical Trials on Niraparib
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Tesaro, Inc.Completed
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Virginia Commonwealth UniversityGlaxoSmithKline; Puma Biotechnology, Inc.RecruitingOvarian Cancer | Advanced Solid TumorUnited States
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Tesaro, Inc.Completed
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Fudan UniversityRecruitingTreatment EfficacyChina
-
Chongqing University Cancer HospitalRecruiting
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Hunan Cancer HospitalUnknown
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Abramson Cancer Center at Penn MedicineActive, not recruitingProstate AdenocarcinomaUnited States
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German Breast GroupGlaxoSmithKline; Stemline Therapeutics, Inc.Not yet recruitingBRCA1 Mutation | BRCA2 Mutation | PALB2 Gene Mutation | Hormone Receptor Positive HER-2 Negative Breast Cancer | Advanced or Metastatic Breast CancerGermany
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Sun Yat-sen UniversityRecruitingNasopharyngeal CarcinomaChina
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MedSIRNot yet recruitingOvarian Cancer | Oligometastatic Disease | Serous Ovarian Tumor