A Phase 2 interventional study of Diflomotecan (BN80915) in Small Cell Lung Cancer, sponsored by Ipsen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-29.
Sponsored by Ipsen · Phase 2, Interventional, and Treatment
This is a Phase II, open-label, multicenter, single-arm, exploratory "proof of concept" study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 9 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Overall objective response rate (tumour assessments should be performed every 6 weeks)
Time to tumour progression
Time to treatment failure
Duration of overall response
Overall complete response, partial response and stable disease
Time to response
Six month and one year survival rates
Median survival
Best overall response
Overall objective response rate
No study locations are listed for this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Ipsen