UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045953 |
|---|---|
| Receipt number | R000052449 |
| Scientific Title | Therapeutic drug monitoring study for avoiding severe neutropenia of amrubicin therapy based on the exposure-response relationship with pharmacokinetic/pharmacodynamic parameters. |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2025/05/07 09:23:38 |
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Basic information
Public title
Therapeutic drug monitoring study for avoiding severe neutropenia of amrubicin therapy based on the exposure-response relationship with pharmacokinetic/pharmacodynamic parameters.
Acronym
TDM study of Amrubicin
Scientific Title
Therapeutic drug monitoring study for avoiding severe neutropenia of amrubicin therapy based on the exposure-response relationship with pharmacokinetic/pharmacodynamic parameters.
Scientific Title:Acronym
TDM study of Amrubicin
Region
| Japan |
Condition
Condition
Small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A Study on the Safety and Efficacy of Therapeutic Drug Monitoring (TDM) in Amrubicin Monotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of FN expression in the first course of treatment
Key secondary outcomes
Percentage of severe neutropenia in the first course of treatment
Relative Dose Intensity (RDI)
Progression-free survival
Overall survival
Cost-effectiveness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Prediction by TDM/uncontrolled
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 histologically or cytologically diagnosed small cell lung cancer.
(2) Patients who have received platinum-based chemotherapy and are scheduled for treatment with amrubicin hydrochloride.
(3) Patients aged 20 years or older at the time of consent acquisition.
4) ECOG performance status of 0 or 1 at the time of enrollment
5) Body surface area less than 2.0 m2 immediately before enrollment (up to 2 weeks before the start of treatment)
(6) Patients who can understand the explanation and consent documents for this clinical trial and have obtained written consent from the patient.
Key exclusion criteria
(1) Patients who have received treatment with amrubicin hydrochloride in the past.
2) Patients who require concomitant use of other anticancer drugs, immunotherapy, or concomitant use of thoracic irradiation.
(3) Patients who have received anticancer drugs (excluding immune check inhibitors) within 3 weeks prior to enrollment or within 5 times the half-life of other therapies, whichever is shorter, or who have not recovered from the toxicity of these previous therapies (grade 1 or up to baseline).
(4) Patients who have not recovered from the toxicity of radiation or major surgery performed prior to the start of enrollment (Grade 1 or baseline).
(5) Patients with symptomatic unstable brain metastasis or central nervous system invasion
(6) Patients currently participating in other clinical trials. (6) Patients currently participating in other clinical trials, but not excluded if they are undergoing follow-up after the completion of the trial or if participation in this clinical trial is permitted in the relevant trial.
(7) Female patients who may be pregnant, or pregnant or lactating women.
(8) Active infectious diseases requiring systemic administration of antimicrobial agents (prophylactic administration is not excluded)
Fluid retention (pleural effusion, pericardial effusion) that requires puncture and drainage within 14 days prior to enrollment and continuous treatment after the procedure
Poorly controlled heart failure, coronary artery disease, arrhythmia, arteriovenous thrombosis, cerebral infarction, diabetes mellitus, autoimmune disease, psychiatric symptoms
Complications of interstitial pneumonia or pulmonary fibrosis evident on chest x-ray (including pre-existing conditions)
(9) COVID-19 positive patients
(10) HIV-positive patients
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Makino |
Organization
Saitama Medical University International Medical Center
Division name
Cancer Genome Medicine / Pharmacy
Zip code
350-1298
Address
Yamane 1397-1 Hidaka
TEL
070-1799-7039
ymakino@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Makino |
Organization
Saitama Medical University International Medical Center
Division name
Cancer Genome Medicine / Pharmacy
Zip code
350-1298
Address
Yamane 1397-1 Hidaka
TEL
0429844161
Homepage URL
ymakino@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center
Address
Yamane 1397-1 Hidaka
Tel
0429844161
ymakino@saitama-med.ac.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
埼玉医科大学国際医療センター、国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2021 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
40/44(1-May-25)
Management information
Registered date
| 2021 | Year | 11 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052449
