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Sponsors and Collaborators: |
Institut Claudius Regaud Merck Sharp & Dohme-Chibret |
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Information provided by: | Institut Claudius Regaud |
ClinicalTrials.gov Identifier: | NCT00801151 |
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.
Condition | Intervention | Phase |
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Malignant Solid Tumour |
Drug: Zolinza (vorinostat), vinorelbine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Phase I Clinical Trial of Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer. |
Estimated Enrollment: | 30 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Vorinostat, vinorelbine: Experimental
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.
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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. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient must have adequate organ function as indicated by the following laboratory values:
Coagulation : prothrombin time (PT) ≤1.2 X ULN ; partial thromboplastin time (PTT) ≤1.2 X ULN
Exclusion Criteria:
Contact: Jean-Pierre Delord, MD, PhD | +33 5 67 69 63 94 | Delord.Jean-Pierre@claudiusregaud.fr |
France | |
Institut Claudius REGAUD | |
Toulouse, France, 31052 | |
Centre René GAUDUCHEAU | |
Nantes Saint Herblain, France, 44805 | |
Institut Curie | |
Paris, France, 75005 |
Principal Investigator: | Jean-Pierre Delord, MD, PhD | Institut Claudius Regaud |
Responsible Party: | Institut Claudius REGAUD ( Dr Jean-Pierre DELORD ) |
Study ID Numbers: | 07 GENE 05 |
Study First Received: | December 2, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00801151 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Vinorelbine Vorinostat |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Pharmacologic Actions Neoplasms |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic |