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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012202
Receipt No. R000014260
Scientific Title Phase 2 study of efficacy and safety of fosaprepitant in patients with solid tumor receiving highly emetogenic chemotherapy
Date of disclosure of the study information 2013/11/01
Last modified on 2018/03/06

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Basic information
Public title Phase 2 study of efficacy and safety of fosaprepitant in patients with solid tumor receiving highly emetogenic chemotherapy
Acronym Phase 2 study of efficacy and safety of fosaprepitant for highly emetogenic chemotherapy
Scientific Title Phase 2 study of efficacy and safety of fosaprepitant in patients with solid tumor receiving highly emetogenic chemotherapy
Scientific Title:Acronym Phase 2 study of efficacy and safety of fosaprepitant for highly emetogenic chemotherapy
Region
Japan

Condition
Condition Patients with solid tumor receiving highly emetogenic chemotherapy including cisplatin.
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of fosaprepitant for antiemetic therapy in patients with solid tumor receiving highly emetogenic chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Complete response rate (defined as no emesis and no rescue treatment) in overall phase(0-120hr after chemotherapy).
Key secondary outcomes 1) Complete response rate in acute (0-24hr after chemotherapy) and delayed (24-120hr after chemotherapy) phases.
2) Complete control rate (defined as no nausea and no emesis and no rescue treatment) in overall, acute and delayed phases.
3) ratio of patients without nausea in overall, acute and delayed phases.
4) adverse events in 14 days after chemotherapy.
5) evaluation of volume of meal intake in acute and delayed phases.

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 Fosaprepitant 150 mg i.v. on day 1 + granisetron 1 mg i.v. on day 1 + dexamethasone 9.9mg i.v. on day 1, 6.6mg i.v. on day 2, and 13.2 mg i.v. on days 3-4.
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 Male and Female
Key inclusion criteria 1) patients with solid tumor receiving highly emetogenic chemotherapy including cisplatin recommended 3-day course of oral aprepitant.
2) patients diagnosed with malignancy histophathologically.
3) aged 20 years or more.
4) Eeatern clinical oncology group performans status is 0 to 2.
5) fulfil all following conditions
ANA >= 1,000/mm3
Plt >= 7,500/mm3
Hb>=8.0g/dl
T.Bil < 2.0 g/dl
AST < 2.0*ULN IU/L
ALT < 2.0*UNL IU/L
CCr >= 60ml/min
6) written informed consent from the patients
Key exclusion criteria 1) patients who have need of administration of aprepitant over 4 days
2) with allergy to aprepitant
3) Possibly pregnant, or breast feeding woman
4) with Acute myocardial infaction in 6 months or with unstable ungina, congestive heart failure (NYHA >= class3), other serious cardiac disoder
5) patients with symptomatic brain metastasis
6) with hypercalcemia requiring an urgent treatment
7) patients taking medicines interacted with CYP3A4 or CYP2C9
8) with uncontrolled diabetes mellitus
9) with pleural effusion, ascitis and pericardial effusion
10) patients who are disqualified by attending physicians
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eishi Baba
Organization Kyushu University
Division name Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka, Japan
TEL 092-642-6921
Email e-baba@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hozumi Kumagai
Organization Kyushu Medical Center
Division name Department of medical oncology
Zip code
Address 1-8-1 Jigyohama, Sawara-ku, Fukuoka City, Fukuoka, Japan
TEL 092-852-0700
Homepage URL
Email hozumik@cancer.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Kyushu University
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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 01 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
2012 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2015 Year 02 Month 01 Day
Date of closure to data entry
2015 Year 12 Month 04 Day
Date trial data considered complete
2015 Year 12 Month 10 Day
Date analysis concluded
2017 Year 04 Month 10 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 01 Day
Last modified on
2018 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014260

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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