Phase 2
Completed N=62
Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
Kidney Cancer · Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT00282048 ↗
Enrolled (actual)
62
Serious AEs
62.9%
Results posted
Apr 2012
Primary outcomePrimary: Percentage of Participants With Objective Response (OR) — 22.6 Percentage of Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
22.6 | — |
| SECONDARY Progression-free Survival (PFS) |
225 | — |
| SECONDARY Duration of Response (DR) |
531 | — |
| SECONDARY Overall Survival (OS) |
412.5 | — |
| SECONDARY Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score |
28.94; 27.12; 27.11; 27.68; 27.94; 27.31 | — |
| SECONDARY Population Pharmacokinetics of Axitinib (AG-013736) |
— | — |
Eligibility Criteria
Inclusion Criteria
- RCC with metastases and nephrectomy
- failure of prior sorafenib-based therapy
- at least 1 target lesion that has not been irradiated
- adequate bone marrow, hepatic and renal function, > or equal to 18 years of age.
Exclusion Criteria
- Gastrointestinal abnormalities
- 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 or evidence of brain metastases.
Data sourced from ClinicalTrials.gov (NCT00282048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.