UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005714 |
|---|---|
| Receipt number | R000006754 |
| Scientific Title | A Phase II trial of immunotherapy with an anti-PD-1 antibody in advanced / relapsed, Platinum - resistant Ovarian Cancer |
| Date of disclosure of the study information | 2011/09/15 |
| Last modified on | 2015/02/12 09:49:51 |
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Basic information
Public title
A Phase II trial of immunotherapy with an anti-PD-1 antibody in advanced / relapsed, Platinum - resistant Ovarian Cancer
Acronym
A Phase II trial of immunotherapy in advanced / relapsed, Platinum - resistant Ovarian Cancer
Scientific Title
A Phase II trial of immunotherapy with an anti-PD-1 antibody in advanced / relapsed, Platinum - resistant Ovarian Cancer
Scientific Title:Acronym
A Phase II trial of immunotherapy in advanced / relapsed, Platinum - resistant Ovarian Cancer
Region
| Japan |
Condition
Condition
ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A purpose of this study is to evaluate the efficacy and safety of an anti-PD-1 antibody to patients with Platinum - resistant ovarian cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Best overall response (Response rate)
Key secondary outcomes
adverse events and adverse drug reaction
Progression free survival (PFS)
Overall survival (OS)
Disease control rate (DCR)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
8 weeks per a course, up to 6 courses.
2 doses, lower dose and upper dose will be applied.
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1) Patients who are confirmed as having epithelial ovarian cancer by cytodiagnosis or tissue diagnosis;
2) Patients whose recurrent and advanced ovarian cancers are determined as platinum refractory.
3)Patients who had undergone more than two regimens of chemotherapy including platinum and taxane as pre-treatment and more than 4 weeks must have elapsed from the last administration of antitumor drug. Combination therapy with another platinum or taxane will be considered as one regimen.
4) Surgical therapy and radiation therapy will not be defined as pre-treatment. It is however required that more than 4 weeks must have elapsed from day of surgery and the last day of radiation therapy;
5) Patients with measurable lesions based on RECIST;
6) Patients with ECOG Performance Status of 0-1;
7) Patients with 3 months of life expectancy;
8) Patients who are classified in NYHA Class I and have not received treatment for arrhythmia;
9) Patients, age between20 years and 79 at the time of informed consent;
10) Patients with major organ functions maintained (updated laboratory data obtained within 7 days prior to enrollment meets all the following criteria)
WBC 2,000/mm3
Platelets 75,000/mm3
Hemoglobin 8g/dL
AST (GOT) 100 IU/L
ALT (GPT) 100 IU/L
Total bilirubin 1.5mg/dL
Serum creatinine 2.0mg/dL
11) Patients who have more than 20 pieces of their paraffin-embedded tumor samples, at least 5m for each section.
12) Patients with written consent forms obtained for participation in this study.
Key exclusion criteria
1) Patients with histories of severe hypersensitive reactions to other antibody drugs.
2) Patients with adverse drug reactions caused by pre-treatment or impacts of complications of surgery or radiation, which are judged to affect the safety assessment of study drug by principle/sub-investigator.
3) Patients with synchronous multiple cancers.
4) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor.
5) Patients with positive test results for HBV, HCV, HIV-1, HIV-2 and HLV-1 antibodies.
6) Patients who are pregnant, nursing or possibly pregnant, or do not agree with contraception until 300 days from the last administration of study drug after informed consent.
7) Patients who received any other study drug or anti-PD-1 antibody within 4 weeks prior to the study drug administration.
8) Patients whom principle/sub-investigator judged ineligible to participate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junzo Hamanishi |
Organization
Kyoto University Hospital
Division name
Gynecology and Obstetrics
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-3269
pd1_obgy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junzo Hamanishi |
Organization
Kyoto University Hospital
Division name
Gynecology and Obstetrics
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-3269
Homepage URL
pd1_obgy@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gynecology and Obstetrics, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 09 | Month | 15 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 26 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 05 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 03 | Day |
Last modified on
| 2015 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006754
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