Phase II Feasibility study of Weekly Amrubicin in Patients with Previously Treated Non-small Cell Lung Cancer

Phase II Feasibility study of Weekly Amrubicin in Patients with Previously Treated Non-small Cell Lung Cancer - Weekly Amrubicin in Previously Treated Non-small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009340

Enrollment

Registered

2012-11-15

Start date

2012-11-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Amrubicin is administered intravenously at a dose of 35 mg/m2/day on days 1,8 and 15 every 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Previously Treated Non-small Cell Lung Cancer (2) ECOG performance status (PS): 0-2 (3) Sufficient function of main organ and bone marrow filled the following criteria: Neutrophil counts, 1,000/mm3 or over Platelets, 50,000/mm3 or over Hemoglobin, 8.0g/dL or over AST and ALT, ULN x 3 or less Serum bilirubin, ULN x 1.5 or less Serum creatinin, x 1.5mg/dL or less Adequate heart function by ECG LVEF (echocardiography), 60% or over SpO2, 93% or over (4) Written informed consent from the patients

Exclusion criteria

Exclusion criteria: (1)Patients with active severe infections (2) Patients with cardiac infarction or necessary cardiac function abnormality of the treatment (3) Patients with active interstitial pneumonia recognized by chest X-ray or chest CT (4) Received the maximum allowed cumulative dose of cardiotoxic drugs such as anthracycline derivatives in prior therapy (5) Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
Adverse events	—

Secondary

Measure	Time frame
Disease control rate Progression-free survival Overall survival	—

Countries

Japan

Contacts

Public ContactMasaharu Inagaki

Tsuchiura Kyodo General Hospital Department of Thoracic Surgery

masaharu_inagaki@yahoo.co.jp029-823-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026