Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer

Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer - Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006370

Enrollment

Registered

2011-09-21

Start date

2011-09-01

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

Squamous Cell Lung Cancer

Interventions

Amrubicin is administered intravenously at a dose of 35 mg/m2/day on days 1-3 every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven squamous cell lung cancer. "2) Patients who have previously treated with chemotherapy. " 3) Patient who has at least one or more measurable lesion by RECIST criteria (Ver.1.1). "4) More than 28 days after last chemotherapy (more than 14 days after the last gefitinib) and more than 28 days rest period after radiation. " 5) ECOG performance status (PS): 0-2 6) Patients aged of 20 to 74 years. "7) Sufficient function of main organ and bone marrow filled the following criteria: " Leukocyte counts, 4,000/mm3 or over and 12,000/mm3 or under Neutrophil counts, 2,000/mm3 or over. Platelets, 100,000/mm3 or over. Hemoglobin, 9.0g/dL or over AST and ALT, x 2.5 of upper limit of normal (ULN) or less. Serum bilirubin, 1.5mg/dl or less. Serum creatinin, x 1.5 of ULN or less. Arterial oxygen partial pressure 60 Torr or over. Adequate heart function by ECG. LVEF (echocardiography), 60% or over. 8) Written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1) Patients who have previously treated with chemotherapy containing amrubicin. 2) Patients with symptomatic brain metastasis. 3) Patients with massive uncontrolled pleural or pericardial effusion ,or ascites. 4) Patients with active severe infections 5) Patients with double cancer within 5 years. 6) Patients with active interstitial pneumonia recognized by chest X-ray. 7) Patients with serious drug allergic reactions. 8) Patients with active concomitant pregnancy. 9) Patients with cardiac infarction or necessary cardiac function abnormality of the treatment. 10) Patients who have previously treated with a cumulative daunorubicin dose > 25 mg/kg, doxorubicin >500 mg/m2, epirubicin >900mg/m2, pirarubicin > 950mg/m2. 11) Patients with active gastric or duodenal ulcer 12) Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
Disease Control Rate (DCR)	—

Secondary

Measure	Time frame
Overall survival, Progression-free survival, Response rate, Safty	—

Countries

Japan

Contacts

Public ContactHiroshi Handa

St.Marianna University School of Medicine Division of Respiratory and Infectious Diseases, Department of Internal Medicine

044-977-8111

Outcome results

None listed

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