Phase 1/2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer

Phase 1

• Conditions: Preaviously untreated advanced advanced squamous cell lung cancer

• Registration Number: JPRN-C000000439
• Lead Sponsor: Department of Respiratory Medicine of Kyoto University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-01
• Study Completion: 2009-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

1) Interstitial pneumonia or pulmonary fibrosis on chest X-P 2) peural or pericardial effusion requiring drainage 3) SVC syndrome 4) Symptomatic brain metastases 5) Active concominant malignancies 6) Uncontrolled diabetes mellitus or hypertension 7) Liver cirrhosis 8) Severe cardiovascular diseases 9) Pregnancy and lactation 10) Ccr<60ml/min 11) A history of serious drug allergy 12) Acute infection 13) Bleeding tendency 14) Unsuitable for entry to the study, decided by a medical oncologist

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recommended dose Dose limmiting toxicity Response Rate

Secondary Outcome Measures

Name	Time	Method
Overall survival Time to progression Toxicity