Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy
NCT ID: NCT01022671
Last Updated: 2016-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2009-09-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Belotecan
Single arm
Belotecan
3.0 mg/m2, Day 1, 8, 15 every 4 weeks
Interventions
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Belotecan
3.0 mg/m2, Day 1, 8, 15 every 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed locally advanced or metastatic NSCLC(Stage IIIB or IV)
* ≥ one measureable or evaluable lesion, \<25% of the bone marrow had been irradiated
* prior platinum based chemotherapy
* ECOG PS ≤ 2
* Life expectancy \> 3 months
* Adequate organ function:
* hematology: ANC ≥ 1.5×109/L, Platelet ≥ 100×109/L, hemoglobin ≥ 9.0g/dL
* hepatic: total bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.0×ULN, ALP ≤2.0×ULN
* renal: serum creatinine ≤ 1.5×ULN
* Signed a written informed consent
Exclusion Criteria
* Symptomatic brain lesion
* Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
* Severe concurrent diseases
* Prior anticancer therapy within 4 weeks before enroll
* Active pregnancy test
19 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Samsung Medical Center
OTHER
Seoul National University Hospital
OTHER
Ulsan University Hospital
OTHER
Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Other Identifiers
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11NSCLC08K
Identifier Type: -
Identifier Source: org_study_id
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