UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012202 |
|---|---|
| Receipt number | 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 18:21:55 |
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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
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
hozumik@cancer.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014260
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