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TERMINATED
NCT00801151
PHASE1

Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer

Sponsor: Institut Claudius Regaud

View on ClinicalTrials.gov

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.

Official title: A Phase I Clinical Trial of Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2009-01

Completion Date

2009-11

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

Zolinza (vorinostat), vinorelbine

Vorinostat will be administered orally at the starting dose of 200 mg po qd 7/21(weekly schedule) in combination with the standard dose of vinorelbine 25mg/m² per week as intravenous infusion over 10 minutes starting 4 hours after vorinostat administration. Barring dose limiting toxicities the dose of vorinostat will escalate in several steps (300 mg po qd 7/21 days, 300 mg po qd 21/21 days, 400 mg po qd 7/21 days, 400 mg po qd 21/21 days). Patients may receive a maximum of 6 cycles of study medication.

Locations (3)

Centre René GAUDUCHEAU

Nantes Saint Herblain, France

Institut Curie

Paris, France

Institut Claudius REGAUD

Toulouse, France