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

Phase 2

• Conditions: Squamous Cell Lung Cancer

• Registration Number: JPRN-UMIN000006370
• Lead Sponsor: St.Marianna University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-21
• Study Completion: 2013-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)

Secondary Outcome Measures

Name	Time	Method
Overall survival, Progression-free survival, Response rate, Safty