UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044778 |
|---|---|
| Receipt number | R000051118 |
| Scientific Title | A feasibility study of Niraparib in patient with recurrent epithelial ovarian cancer after Olaparib maintenance therapy |
| Date of disclosure of the study information | 2021/07/07 |
| Last modified on | 2023/10/10 12:18:53 |
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Basic information
Public title
A feasibility study of Niraparib in patient with recurrent epithelial ovarian cancer after Olaparib maintenance therapy
Acronym
NAO study
Scientific Title
A feasibility study of Niraparib in patient with recurrent epithelial ovarian cancer after Olaparib maintenance therapy
Scientific Title:Acronym
NAO study
Region
| Japan |
Condition
Condition
Epithelial Ovarian Cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study examines the feasibility of Niraparib maintenance therapy after response to a platinum-containing regimen in patients with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have relapsed after olaparib maintenance therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
treatment completion proportion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Niraparib 200mg capsules administered orally once daily continuously. Drug suspension, dose reduction, and prescription discontinuation will be carried out according to the package insert.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. At least 20 years old
2. Patients who understand that consent can be withdrawn at any time without penalizing future treatment and give written consent.
3. Patients histologically diagnosed with ovarian, fallopian tube or primary peritoneal cancer
4. Patients receiving maintenance therapy, including olaparib.
(Including patients who received maintenance therapy with bevacizumab at the time of initial treatment)
5. Patients who have completed 2 or more lines of chemotherapy containing platinum
Note: The last platinum regimen does not have to follow directly to the penultimate platinum regimen line, if all the selection criteria are met.
a. Patients who showed platinum susceptibility to the penultimate line of platinum regimens prior to enrollment.
b. Patients who meet both of the following b-1 to b-2 in the last platinum regimen before enrollment:
b-1. Patients who have received at least 4 cycles of platinum regimen
b-2. Patients who have achieved CR or PR and can maintain Niraparib oral administration
c. Patients within 12 weeks of enrollment in this study after the last dose of platinum.
6. Eastern Cooperative Oncology Group performance status of 1 or less
7. Patients with proper organ function and laboratory test values that meet the following criteria:
a. Absolute number of neutrophils: 1,500/microL or more
b. Platelet count: 100,000 /microL or more
c. Hemoglobin value: 9 g / dL or more (allows red blood cell transfusion before the start of treatment)
d. Serum creatinine level is 1.5 times or less than ULN, or Cockcroft-Gault estimation formula creatinine clearance value is 50 mL / min or more.
e. Total bilirubin value is 1.5 times or less of ULN, or direct bilirubin value is ULN or less
f. AST and ALT: 2.5 times or less of ULN, 5 times or less of ULN if having liver metastasis
8. Patients who can orally administer the study drug
9. Non-pregnant woman
Key exclusion criteria
1. Patients with persistent Grade 3 or higher toxicity from previous chemotherapy
2. Patients with untreated double cancer
3. Patients with brain metastases or pial meningeal metastases
4. Patients who have undergone ascites drainage since the start of the last two cycles of chemotherapy
5. Patients who are hypersensitive to the components of the study drug or its related compounds
6. Patients who have previously received PARP inhibitors for the treatment of other diseases
7. Patients who underwent major surgery (at the discretion of the investigator) within 3 weeks before the first dose. The patient must have recovered from all the effects of major surgery.
8. Patients at high medical risk due to uncontrolled serious illness, non-malignant systemic illness, or uncontrolled active infection.
9. Patients with any disease, treatment or laboratory abnormalities that affect the test results [myelosuppression with poor control (anemia, leukocyte depletion, neutropenia or thrombocytopenia), etc.]
10. Women who are pregnant, planning to become pregnant, or breastfeeding. However, if a lactating woman stops breastfeeding, she can register.
11. Immunosuppressed patients (patients undergoing splenectomy are acceptable)
12. Patients known to be positive for human immunodeficiency virus (HIV)
13. Patients with known or suspected hepatitis B virus surface antigen (HBsAg) positive or active hepatitis C virus (HCV) infection
Note: Patients with hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled, but hepatitis B virus (HBV) must be below the detection limit. Patients who are positive for hepatitis C virus antibody (HCVAb) must have HCV below the detection limit.
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Hyogo Cancer Center
Division name
Gynecologic Oncology
Zip code
673-8558
Address
13-70Kitaoji-cho, Akashi-city
TEL
078-929-1151
s-yama@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakazawa |
Organization
Hyogo Cancer Center
Division name
Gynecologic Oncology
Zip code
673-8558
Address
13-70Kitaoji-cho, Akashi-city
TEL
078-929-1151
Homepage URL
nakazawa-gyne@hyogo-cc.jp
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Cancer Center IRB
Address
13-70Kitaoji-cho, Akashi-city
Tel
0789291151
rinsyoshikenkanri6@hyogo-cc.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2021 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051118
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| Registered date | File name |
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