Phase I, Open-Label, Multicenter, Dose-Escalation Study Of The Tyrosine Kinase Inhibitor Of VEGFR-2, AG013736, In Patients With Advanced Solid Tumors
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
MTD is defined as the dose level at which "no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD)." DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.
Baseline up to Day 28
Yes
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
AG013736-001
NCT01469052
November 2002
August 2004
Name | Location |
---|---|
Pfizer Investigational Site | Blendora, California 91740 |
Pfizer Investigational Site | Houston, Texas 77030 |
Pfizer Investigational Site | Milwaukee, Wisconsin 53215 |