Phase 2
Completed N=52
Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma
Source: ClinicalTrials.gov NCT00076011 ↗Enrolled (actual)
52
Serious AEs
53.8%
Results posted
Mar 2012
Primary outcomePrimary: Percentage of Participants With Objective Response (OR) — 44.2 Percentage of participants
Summary
The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
44.2 | — |
| SECONDARY Time to Disease Progression (TTP) |
477.0 | — |
| SECONDARY Duration of Response (DR) |
700.0 | — |
| SECONDARY Overall Survival (OS) |
911.0 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score |
68.9; -6.0; -0.3; -4.9; -7.6; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically documented RCC with metastases.
- Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to disease progression or unacceptable treatment-related toxicity
Exclusion Criteria
- Any prior systemic treatment for Renal Cell Carcinoma [RCC] other than 1 prior cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or an anti-angiogenesis agent are not allowed.
- Inability to take oral medication
Data sourced from ClinicalTrials.gov (NCT00076011). 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.