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| Sponsor: | Institut Claudius Regaud |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Institut Claudius Regaud |
| ClinicalTrials.gov Identifier: | NCT00801151 |
Purpose
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 |
|---|---|---|
|
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: | January 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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. |
Eligibility| 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:
Contacts and Locations| Contact: Jean-Pierre Delord, MD, PhD | +33 5 67 69 63 94 | Delord.Jean-Pierre@claudiusregaud.fr |
| France | |
| Institut Claudius REGAUD | Recruiting |
| Toulouse, France, 31052 | |
| Sub-Investigator: Florence DALENC, MD, PhD | |
| Sub-Investigator: Loïc MOUREY, MD, PhD | |
| Centre René GAUDUCHEAU | Recruiting |
| Nantes Saint Herblain, France, 44805 | |
| Principal Investigator: Mario CAMPONE, MD, PhD | |
| Sub-Investigator: Jaafar BENNOUNA, MD, PhD | |
| Sub-Investigator: Jean-Yves DOUILLARD, MD, PhD | |
| Sub-Investigator: Frederic ROLLAND, MD, PhD | |
| Sub-Investigator: Helene SENELLART, MD, PhD | |
| Sub-Investigator: Emmanuelle BOMPAS, MD, PhD | |
| Sub-Investigator: Dominique BERTON-RIGAUD, MD, PhD | |
| Sub-Investigator: Emmanuelle BOURBOULOUX, MD, PhD | |
| Institut Curie | Recruiting |
| Paris, France, 75005 | |
| Principal Investigator: Jean-Yves PIERGA, MD, PhD | |
| Sub-Investigator: Veronique DIERAS, MD, PhD | |
| Sub-Investigator: Laurent MIGNOT, MD, PhD | |
| Sub-Investigator: Diego TOSI, MD, PhD | |
| Sub-Investigator: Patricia TRESCA, MD, PhD | |
| Principal Investigator: | Jean-Pierre Delord, MD, PhD | Institut Claudius Regaud |
More Information
| Responsible Party: | Institut Claudius REGAUD ( Dr Jean-Pierre DELORD ) |
| Study ID Numbers: | 07 GENE 05 |
| Study First Received: | December 2, 2008 |
| Last Updated: | March 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00801151 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Vorinostat Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Pharmacologic Actions Neoplasms |
Vinorelbine 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 |