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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009702
Receipt No. R000011373
Scientific Title Efficacy of Aprepitant for Hematology and Oncology.
Date of disclosure of the study information 2013/01/20
Last modified on 2014/02/09

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Basic information
Public title Efficacy of Aprepitant for Hematology and Oncology.
Acronym Efficacy of Aprepitant for Hematology and Oncology.
Scientific Title Efficacy of Aprepitant for Hematology and Oncology.
Scientific Title:Acronym Efficacy of Aprepitant for Hematology and Oncology.
Region
Japan

Condition
Condition Hematological malignancies
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In the first step , we investigate a situation of nausea and vomiting and anorexia in patients receiving chemotherapy for hematological tumors. Next step, we evaluate the efficacy of aprepitant in patients who induced nausea and vomiting and anorexia in the first step. In addition, we assess the influence of aprepitant on antitumor effect in patients administerd steroids as cancer chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The difference of the incidence of nausea and vomiting
Key secondary outcomes The proportion of patients with Complete Response (no emesis and no rescue therapy) in the overall phase (0-120 hour after administration of antitumor agent).
The proportion of patients with Complete Response ( no emesis and no rescue therapy ) in Day 1 or Day 2 - Day 5.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 aprepitant(d1-3)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Received the chemotherapy for blood tumor
2. able to record the onset of vomiting and nausea in a symptom diary
3. patients who induced nausea and vomiting and anorexia and rescue therapy in the first chemotherapy.
4. Performance Status(PS) of 0-2
5. estimated life expectancy of at least 3 months
6. aspartate aminotransferase (AST) (glutamic oxaloacetic transaminase (GOT)) and alanine aminotransferase(ALT) (glutamic pyruvic transaminase (GPT))<2.5 x upper limit of the normal range at the facility
7. total bilirubin <1.5 x upper limit of the normal range at the facility
8. creatinine <1.5 x upper limit of the normal range at the facility
Key exclusion criteria 1. chemotherapy within 6 days before study day 1 or between days 1 to 6.
2. Antiemetic therapy prior to 48 hr of chemotherapy.
3. Corticosteroids therapy within 72 hr before study day 1 or duration of study
4. Radiation therapy to the abdomen or pelvis within 6 days before study day 1 or duration of study
5. known central nervous system malignancy
6. following drug therapy within 6 days before study day 1
- clarithromycin, ketoconazole,

itraconazole -
7. following drug therapy within 4 weeks before study day 1
- barbiturate, rifampicin, phenytoin, carbamazepine -
8. pregnant, nursing or possibly pregnant
women
9. Patients judged inappropriate for this study by physicians
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akifumi Takaori
Organization Kyoto University Hospital
Division name Department of Hematology and Oncology
Zip code
Address 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto-shi, Kyoto
TEL 075-751-3150
Email atakaori@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadakazu Kondo
Organization Kyoto University Hospital
Division name Department of Hematology and Oncology
Zip code
Address 54 Kawaramachi, Seigoin, Sakyo-ku, Kyoto-shi, Kyoto
TEL 075-366-7550
Homepage URL
Email tadakazu@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital,Department of Hematology and Oncology
Institute
Department

Funding Source
Organization none
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 京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 20 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 Preinitiation
Date of protocol fixation
2013 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 06 Day
Last modified on
2014 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011373

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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