PhaseI/IIstudy of AMR in elderly patients with small-cell lung cancer previously treated with platina-based chemotherapy

Phase 1

• Conditions: small-cell lung cancer

• Registration Number: JPRN-UMIN000005606
• Lead Sponsor: ung Oncology Group in Kyushu, Japan (LOGIK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-16
• Study Completion: 2013-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Previously treated with amrubicin hydrochloride (2)Interstitial pneumonia or pulmonary fibrosis suspected on chest CT (3)Abnormal cardiac function, myocardial infarction, or history thereof (4)Received the maximum allowed cumulative dose* of cardiotoxic drugs such as anthracycline derivatives in prior therapy *Maximum allowed cumulative doses are 25 mg/kg (body weight) for daunorubicin hydrochloride, 500 mg/m2 (body surface area) for doxorubicin hydrochloride, 900 mg/m2 for epirubicin hydrochloride, and 950 mg/m2 for pirarubicin hydrochloride (5)Symptomatic brain metastases (6)Pleural effusion, ascites, or pericardial effusion requiring drainage(7)Serious complications (cancerous pericarditis, superior vena cava syndrome, serious infection) (8)History of drug allergy judged unacceptable for participation in the study (9)Pregnant, possibly pregnant, or desire to become pregnant (10)For other reasons judged by the investigator (principal investigator or subinvestigator) to be inappropriate for this study (11)Active multiple cancers treated within the past 5 years as of the day of enrollment or during treatment with amrubicin hydrochloride (12)Uncontrolled diabetes mellitus, chronic steroid use

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1: Estimation of the DLT and MTD, determination of the RD, assessment of adverse events. severity of adverse events is assessed according to the "Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0."Phase 2: Response rate (CR + PR) Tumor response is assessed according to the "Response Evaluation Criteria in Solid Tumors (the RECIST criteria)."