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A Prospective Single-center dose escalation study on the Safety of Lactoferin for post-treated advanced & recurrent non-small cell lung cancer

Phase 1
Conditions
on-small cell lung cancer
Registration Number
JPRN-UMIN000007120
Lead Sponsor
Kanagawa Cancer Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
18
Inclusion Criteria

Not provided

Exclusion Criteria

1)pulmonary fibrosis or interstitial pneumonitis evident 2)Massive pleural effusion, pericardial effusion,and abdominal effusion 3)Simultaneous or metachronous double cancers 4)serious complications below a)myocardial infarction within 6 months b)Uncontrolled diabetes or hypertension c)Current severe infection, or suspicious of severe infection d)History of serious drug allergic reaction e)Massive effusion or edema f)Patients whose participation in the trial is judged to be inappropriate by the attending doctor 5)Symptomatic brain metastasis 6)now pregnant or lactation 7)History of radiation therapy or operation for lung cancer within 28 days at the time of entry. 8)History of unapproved drugs within 28 days at the time of entry. 9)Participation in this study before 10)History of serious allergic reaction with S-1 11)Being treated with other pyrimidine fluoride antineoplastic agents. 12)Being treated with flucytosine. 13)Wattery diarrhea 14)lactose intolerance 15)difficult to perform or continue of this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
RD : Recommended Dose
Secondary Outcome Measures
NameTimeMethod
Safety,Efficacy,Immunological response,QO
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