UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046056
Receipt No. R000052565
Scientific Title Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia
Date of disclosure of the study information 2021/11/15
Last modified on 2021/11/12

* 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 Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia
Acronym Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia
Scientific Title Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia
Scientific Title:Acronym Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of anamorelin in chemotherapy using S-1 for unresectable advanced or postoperative recurrent gastric cancer patients with cachexia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body weight change rate 12 weeks after anamorelin administration
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patients who are scheduled or undergoing chemotherapy containing S-1 for unresectable advanced gastric cancer or postoperative recurrent gastric cancer
2. Patients with cachexia who are covered by anamorelin insurance: Within 6 months, 5% or more weight loss and loss of appetite are observed, and two or more of the following A to C are observed.
(A) Fatigue or fatigue
(B) Weakness of the whole body
(C) One or more of CRP> 0.5mg / dL, Hb <12g / dL, Alb <3.2g / dL
3. Patients scheduled to receive anamorelin
4. Patients who have received sufficient explanation before participating in this study, and who have obtained the patient's free will to consent to the document after sufficient understanding.
Key exclusion criteria 1. Patients with gastrointestinal disorders who have difficulty in taking food orally or who require gastrointestinal rest
2. Patients with congestive heart failure, underlying heart disease (valvular disease, cardiomyopathy, etc.), history of myocardial infarction or angina, conduction system disorder, risk of QT interval prolongation or a history thereof
3. Patients with a history of administration of anthracyclines
4. Patients receiving strong CYP3A4 inhibitors (drugs containing clarislomycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir, cobicistat)
5. Patients who have confirmed ascites in an amount exceeding the physiological range
6. Patients with confirmed pleural effusion
7. Patients with moderate or higher liver dysfunction (Child-Pugh classifications B and C)
8. Patients judged by the attending physician to be inappropriate for participation in the study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Fumihiko
Middle name
Last name Hatao
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Surgery
Zip code 183-8524
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL 0423235111
Email fchobi@gmail.com

Public contact
Name of contact person
1st name Fumihiko
Middle name
Last name Hatao
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Surgery
Zip code 183-8524
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL 0423235111
Homepage URL
Email fchobi@gmail.com

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Department of Surgery
Institute
Department

Funding Source
Organization Tokyo Metropolitan Tama Medical Center
Department of Surgery
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Metropolitan Tama Medical Center
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
Tel 042-323-5111
Email tamarinshou@tmhp.jp

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

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 15 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
2021 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 11 Month 15 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information When chemotherapy containing S-1 is being or will be given and cachexia is confirmed, the study will be described once it has been confirmed that it meets other indication criteria and does not meet the exclusion criteria.
Anamorelin will be administered with reference to the package insert. When visiting a medical institution for outpatient chemotherapy, etc., the continuation of anamorelin confirms the patient's intention as much as possible for each prescription to see if the test can be continued by blood tests and interviews. Anamorelin will end 12 weeks after the start, according to the insurance coverage criteria. Body weight, blood findings, interviews, etc. will be conducted even 4 weeks after the end of anamorelin. If S-1 is ineffective or discontinued due to an adverse event, anamorelin dosing is medically acceptable and will continue for up to 12 weeks if the patient so desires. Medication will be discontinue if the patient does not wish to continue anamorelin or if there are serious adverse events caused by anamorelin. Even if anamorelin is discontinued, evaluation and observation for the study will continue with the consent of the patient.

Management information
Registered date
2021 Year 11 Month 12 Day
Last modified on
2021 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052565

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.