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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005714
Receipt No. 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

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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
Obsterics 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&#61549;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
Email 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
Email pd1_obgy@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Gynecology and Obstetrics, Kyoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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