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Main
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Note: This record shows only 22 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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12 December 2020 |
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Main ID: |
NCT00080015 |
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Date of registration:
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19/03/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)
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Scientific title:
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A Phase II Open Label Study Investigating the Activity of Diflomotecan (BN80915) Administered at the Fixed Dose of 7mg as a 20 Minute Intravenous Infusion Once Every 3 Weeks in Patients With Sensitive Small Cell Lung Cancer (SCLC) Who Have Failed First-line Treatment With a Platinum Based Regimen. |
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Date of first enrolment:
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March 12, 2004 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00080015 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Contacts
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Name:
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Ipsen Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ipsen |
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
- Documented small cell lung cancer (SCLC)
- Measurable disease
- One line of previous chemotherapy, including any platinum analogue, and excluding any
camptothecin analogues, with objective response and relapsed no less than 3 months
Main Exclusion Criteria:
- Uncontrollable brain metastasis
- Treated with an investigational drug within 30 days
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Small Cell Lung Cancer
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Intervention(s)
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Drug: Diflomotecan (BN80915)
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Primary Outcome(s)
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Overall objective response rate (tumour assessments should be performed every 6 weeks)
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Secondary Outcome(s)
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Overall objective response rate
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Overall complete response, partial response and stable disease
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Six month and one year survival rates
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Best overall response
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Median survival
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Duration of overall response
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Time to treatment failure
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Time to response
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Time to tumour progression
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Secondary ID(s)
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2-91-52990-708
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2004-001350-92
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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