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FdCyd + THU in Advanced Solid Tumors
NCT00978250Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2009
- Primary completion
- Apr 2019
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Conditions
- non-small cell lung cancer (NSCLC)breast cancerurothelial carcinoma (UC)head and neck cancer (HNC)
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Overview
Phase 2, open-label, single-arm trial of 5-fluoro-2'-deoxycytidine in non-small cell lung cancer (NSCLC), breast cancer, urothelial carcinoma (UC) and 1 more, sponsored by National Cancer Institute. Primary endpoints: Progression-free Survival at 1 year and Percentage of Participants With Complete Response (CR) + Partial Response (PR) at 1 year. Started Aug 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
FdCyd + THU
5-Fluoro-2'-Deoxycytidine + Tetrahydrouridine
03
Who it enrols
Adult patients with advanced NSCLC, breast, bladder, or head and neck cancer who have progressed on standard therapy, with measurable disease and normal organ function.
04
Endpoints
Primary
Progression-free Survival
Percentage of Participants With Complete Response (CR) + Partial Response (PR)
Secondary
Number of Participants With Serious and Non-serious Adverse Events
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