CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
AG-013736 (axitinib)drug
Likely dose
AG-013736 (axitinib) 5 mg twice daily continuous dosing in 28 day cyclesAI-extracted
Key inclusion· 5
  • ✓Metastatic renal cell carcinoma with prior nephrectomy
  • ✓Documented failure of prior sorafenib-based therapy
  • ✓At least one target lesion not previously irradiated
  • ✓Age ≥18 years
Key exclusion· 5
  • ✕Gastrointestinal abnormalities that would impair drug absorption
  • ✕Current use or inability to avoid chronic antacid therapy
  • ✕Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2 inducers
  • ✕Active seizure disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00282048
NCT00282048Phase 2Completed
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Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer

Pfizer·interventional·Posted Jan 25, 2006·Updated Jul 31, 2012

In Brief

A Phase 2 clinical trial evaluating AG-013736 (axitinib) for Kidney Neoplasms and Carcinoma, Renal Cell. Completed, enrolled 62 participants across 5 sites.

Detailed Summary

To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Neoplasms, Carcinoma, Renal Cell
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 25, 2006
Enrollment StartMar 1, 2006
Primary CompletionFeb 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.4 years ago

Interventions

AG-013736 (axitinib)drug

AG-013736 5 mg twice daily \[bid\] continuous dosing in 28 day cycles.