Therapeutic drug monitoring study for avoiding severe neutropenia of amrubicin therapy based on the exposure-response relationship with pharmacokinetic/pharmacodynamic parameters. - TDM study of Amrubicin

Saitama Medical University0 sites44 target enrollmentNovember 1, 2021

ConditionsSmall cell lung cancer

Overview

Phase: 未知
Intervention: Not specified
Conditions: Small cell lung cancer
Sponsor: Saitama Medical University
Enrollment: 44
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 1, 2021

End Date

March 31, 2030

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Saitama Medical University

Eligibility Criteria

Inclusion Criteria

Not provided

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