Phase I/II trial of Amrubicin Hydrochloride in 3rd line treatment for patients with Recurrent Non-small cell Lung cancer [AMNOL-3rd]

UMIN ID: UMIN000000726

Registered date:28/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Previously treated non-small cell lung cancer
• Date of first enrollment: 2007/01/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Amrubicin hydrochloride is given at previously decided dose intraveniously for three consecutive days every 3 weeks.

Outcome(s)

• Primary Outcome: Phase I;To verify MTD and RD Phase II; primary endpoint: disease control rate, response rate secondary endpoint: overall survival(OS), progression free survival (PFS),safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion, pericardial effusion, or ascites, pregnancy, lactation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, or severe infection. Patients who have already received amrubicin and other anthracycline drugs were excluded, too.

Related Information

• Primary Sponsor: Keio University School of Medicine Division of Pulmonary Medicine
• Source(s) of Monetary Support: Keio University School of Medicine Division of Pulmonary Medicine