Phase I Trial of ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies
To determine the maximum tolerated dose of Depakote in combination with liposome
encapsulated all-trans retinoic acid (ATRA-IV) in patients with advanced solid tumor
malignancies.
This will be a 2-step dose escalation study. Once the patient starts therapy at a
designated dose level, it will not be escalated for that patient. Three patients at each
dose level must complete 4 weeks of therapy before escalating to the next higher level. If
none of the patients experience dose limiting toxicity (DLT), then 3 new patients will be
treated with the next higher dose level.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose of Depakote in combination with liposome encapsulated all-trans retinoic acid (ATRA-IV) in patients with advanced solid tumor malignancies.
David Nanus, M.D.
Principal Investigator
Weill Medical College of Cornell University
United States: Food and Drug Administration
1002-536
NCT00195156
July 2003
Name | Location |
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Weill Medical College of Cornell University | New York, New York 10021 |