UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004998
Receipt number R000005943
Scientific Title A multicenter, double-blind, placebo-controlled phase II study of apreipitant for prevention of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC) in women younger than 70 years without alcohol drinking habit
Date of disclosure of the study information 2011/02/01
Last modified on 2013/02/01 12:44:28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A multicenter, double-blind, placebo-controlled phase II study of apreipitant for prevention of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC) in women younger than 70 years without alcohol drinking habit

Acronym

A randomized phase II study of apreipitant in women younger than 70 years without alcohol drinking habit

Scientific Title

A multicenter, double-blind, placebo-controlled phase II study of apreipitant for prevention of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC) in women younger than 70 years without alcohol drinking habit

Scientific Title:Acronym

A randomized phase II study of apreipitant in women younger than 70 years without alcohol drinking habit

Region

Japan


Condition

Condition

Female cancer patients younger than 70 years without alcohol drinking habit

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this sudy is to investigate the efficacy of aprepitant in female cancer patients younger than 70 years without alcohol drinking habit for CINV following carboplatin or inrinotecan based regimens.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

the proportion of patients with complete response (CR), defined as no vomiting and no use of rescue therapy, during 120 h after initiation of chemotherapy in cycle 1

Key secondary outcomes

The key secondary objectives are proportions of women with no vomiting with rescue use, or with total control (no nausea, no vomiting and no rescue use) during the 120 h post-chemotherapy.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Aprepitant arm: day 1, aprepitant 125 mg, granisetron 1 mg, and dexamethasone 12 mg before chemotherapy; days 2 through 3, aprepitant 80 mg qd and dexamethasone 4 mg qd

Interventions/Control_2

Control arm: day 1, granisetron 1 mg and dexamethasone 20 mg before chemotherapy; days 2 through 3, dexamethasone 8 mg qd

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

70 years-old >

Gender

Female

Key inclusion criteria

Eligible women younger than 70 years old without alcohol drinking habi, na&iuml;ve to APR with lung, colorectal, gynecologic or primary unknown cancer are treated with carboplatin (AUC 5-6) or irinotecan (more than 150 mg/m2) based regimens.

Key exclusion criteria

Any anthracylin and cyclophosphamide (AC) regimens are not permitted.

Target sample size

94


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunichi Negoro

Organization

Hyogo Cancer Center

Division name

Medical oncology

Zip code


Address

13-70 Kita-oji, Akashi, Hyogo

TEL

078-929-1151

Email



Public contact

Name of contact person

1st name
Middle name
Last name Maki Tanioka

Organization

Hyogo Cancer Center

Division name

Medical oncology

Zip code


Address

13-70 Kita-oji, Akashi, Hyogo

TEL

078-929-1151

Homepage URL


Email

tanioka@hp.pref.hyogo.jp


Sponsor or person

Institute

Hanshin Cancer Study Group

Institute

Department

Personal name



Funding Source

Organization

Hanshin Cancer Study Group

Organization

Division

Category of Funding Organization

Other

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

兵庫県立がんセンター、先端医療センター、大阪府立成人病センター


Other administrative information

Date of disclosure of the study information

2011 Year 02 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

2011 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date

2013 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 02 Month 01 Day

Last modified on

2013 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005943


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name