Status Approved
First Submitted Date
2021/03/24
Registered Date
2021/04/05
Last Updated Date
2021/07/06
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006051 |
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Unique Protocol ID | 4-2021-0076 |
Public/Brief Title | A single-arm phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor |
Scientific Title | A single-arm phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | Yes |
Name of Registry / Registration Number | ClinicalTrials.gov-NCT04734665 |
Healthcare Benefit Approval Status | Submitted pending |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 4-2021-0076 |
Approval Date | 2021-03-17 |
Institutional Review Board Name | Yonsei University Health system, Severance Hospital, Institutional Review Board |
Institutional Review Board Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul |
Institutional Review Board Telephone | 02-2228-0435 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Jungyun Lee |
Title | Professor |
Telephone | +82-2-2228-2237 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul |
Contact Person for Public Queries | |
Name | Yunjung Go |
Title | Clinical Research Co |
Telephone | +82-2-2228-0570 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul |
Contact Person for Updating Information | |
Name | Hyeyoon Lee |
Title | Clinical Research Co |
Telephone | +82-2-2228-0554 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-07-05 Actual | |
Target Number of Participant | 44 | |
Primary Completion Date | 2024-03-16 , Anticipated | |
Study Completion Date | 2024-03-16 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Yonsei University Health System, Severance Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-07-05 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Takeda |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University Health System, Severance Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | -Primary Aim/Objective : To determine the efficacy of niraparib re-treatment with bevacizumab by assessment of Progression-free survival (PFS) - Hypothesis : Niraparib re-treatment with Bevacizumab is synergistic in patients previously treated with a PARP inhibitor - Treatment : niraparib po 200mg or 300mg QD* bevacizumab iv15mg/kg every 3 weeks (Q3W) |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase2 |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Non-RCT |
Intervention Type | Drug |
Intervention Description | If the subject has enrolled, the drugs will be administered until PD as below. - niraparib po 200mg or 300mg QD* - bevacizumab iv15mg/kg every 3 weeks (Q3W) |
Number of Arms | 1 |
Arm 1 |
Arm Label Experimental |
Target Number of Participant 44 |
|
Arm Type Experimental |
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Arm Description If the subject has enrolled, the drugs will be administered until PD as below. - niraparib po 200mg or 300mg QD* - bevacizumab iv15mg/kg every 3 weeks (Q3W) |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C56.9)Malignant neoplasm of ovary, unspecified side Ovarian cancer |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 20Year~No Limit |
|
Description 1) Participant has histologically confirmed diagnosis of high-grade predominantly serous, endometrioid, carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC, primary peritoneal cancer, or fallopian tube cancer will be enrolled in this study (only up to 4 patients with clear cell carcinoma will be included and mucinous carcinoma will not be included). 2) Participant has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 12 months’ period between penultimate platinum regimen and progression of disease) Note: The last platinum regimen does not necessarily have to immediately follow the next to last (penultimate) platinum regimen. For example, if a patient received a non-platinum regimen between the penultimate platinum regimen and last platinum regimen, they could be eligible, so long as they meet all entry criteria. 3) Participant has responded to last the platinum regimen (complete or partial response), remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen 4) Participant had prior treatment with PARP inhibitor 5) Participant is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA 1/2 and PD-L1 status prior to enrollment. 6) Female participants who are at least 20 years of age on the day of signing informed consent with. 7) Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to enrollment. 8) A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days following the last dose of niraparib and at least 210 days following the last dose of chemotherapy or bevacizumab 9) The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. The participant may also provide consent for future biomedical research; however, the participant may participate in the main study without participating in future biomedical research. 10) Participant has adequate organ function as defined in the following table (Table 1).; all screening laboratory tests should be performed within 10 days prior to the start of study treatment Table 1 Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1500/µL Platelets ≥100 000/µL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Criteria must be met without erythropoietin dependency. b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies. |
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Exclusion Criteria |
1) Participant has mucinous, germ cell, or borderline tumor of the ovary. 2) Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis. 3) Participant either has myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or has features suggestive of MDS/AML. 4) Participant has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, endometrial carcinoma) that have undergone potentially curative therapy are not excluded. Note: Participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than IA: no more than superficial myometrial invasion 5) Drainage of ascites during last 2 cycles of last chemotherapy. 6) Palliative radiotherapy within 1 week encompassing >20% of the bone marrow. 7) Persistent > grade 2 toxicity from prior cancer therapy. 8) Symptomatic uncontrolled brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically stable disease for 28 days. 9) Known hypersensitivity to the components of niraparib. 10) Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery. 11) Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. 12) History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient‘s participation for the full duration of the study treatment, or is not in the best interest of the patient to participate. 13) Immunocompromised patients 14) Patients with known active hepatic disease (i.e. , Hepatitis B or C). |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | progression-free survival |
|
Timepoint | 6months |
|
Secondary Outcome(s) 1 | ||
Outcome | Overall survival (OS) |
|
Timepoint | Up to 1year |
|
Secondary Outcome(s) 2 | ||
Outcome | Time to tumour progression (TTP) |
|
Timepoint | Up to 1year |
|
Secondary Outcome(s) 3 | ||
Outcome | Time to first subsequent treatment(or death) |
|
Timepoint | The date of first documented first subsequent treatment or date of death, assessed up to 72 months |
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Secondary Outcome(s) 4 | ||
Outcome | Time to second subsequent treatment |
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Timepoint | The date of first documented second subsequent treatment assessed up to 72 months |
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Secondary Outcome(s) 5 | ||
Outcome | progression-free survival |
|
Timepoint | Up to 1year |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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