Spots Global Cancer Trial Database for Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer
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Trial Identification
Brief Title: Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer
Official Title: A Phase I Clinical Trial of Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer.
Study ID: NCT00801151
Conditions
Interventions
Study Description
Brief Summary: This is a multi-center, open-label non-randomized dose-escalation trial of vorinostat given in combination with vinorelbine. Cohorts will be treated with a fixed dose of vinorelbine (25mg/m²/week continuously, representing the schedule that has been approved). Patients eligible will be enrolled into a standard 3+3 design with a starting dose of vorinostat at 200 mg po qd 7/21 (weekly schedule). Then, further dose levels will be explored. Toxicity of the schedule will be assessed during the first cycle. Patients may receive up to 6 cycles of study medication. Blood samples will be collected at specified time points to assess pharmacokinetic endpoints.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre René GAUDUCHEAU, Nantes Saint Herblain, , France
Institut Curie, Paris, , France
Institut Claudius REGAUD, Toulouse, , France
Contact Details
Name: Jean-Pierre Delord, MD, PhD
Affiliation: Institut Claudius Regaud
Role: PRINCIPAL_INVESTIGATOR
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