Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer

Sponsor
Institut Claudius Regaud
Study ID
NCT00801151
Phase
PHASE1
Status
Terminated

Conditions

  • Malignant Solid Tumour

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zolinza (vorinostat), vinorelbine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2009
Status verified
May 2010
Primary completion
Oct 31, 2009
Completion
Nov 30, 2009

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

To determine the maximum tolerated dose (MTD) of vorinostat administered in combination with standard doses of vinorelbine. [ Time Frame: at the end of the trial ]

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