UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 study of efficacy and safety of fosaprepitant in patients with solid tumor receiving highly emetogenic chemotherapy
Title of the study (Brief title)	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	Eishi Baba
Organization	Kyushu University
Division name	Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences
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	Hozumi Kumagai
Organization	Kyushu Medical Center
Division name	Department of medical oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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