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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00191971 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen
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Scientific title:
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A Phase II Study of Gemcitabine in Transitional Cell Carcinoma of the Urothelium |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00191971 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically and/or cytologically confirmed TCC
- Received 1st line chemotherapy for locally advanced or metastatic TCC with CDDP
regimen
- To have at least one measurable region
- PS: 0-2
- To have adequate organ function (bone marrow, liver and renal function)
Exclusion Criteria:
- To have Interstitial pneumonia or pulmonary fibrosis
- Within 4 weeks after the latest chemotherapy or radiotherapy
- To have brain metastasis with symptom
- To have severe complication (cardiac infarction, infection, drug hyper sensitivity or
diabetes)
Age minimum:
20 Years
Age maximum:
74 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma, Transitional Cell
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Urologic Neoplasms
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Intervention(s)
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Drug: Gemcitabine
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Primary Outcome(s)
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Response rate
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Secondary Outcome(s)
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Overall survival
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Progression-free survival
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Secondary ID(s)
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7994
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B9E-JE-BL21
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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