Phase 2
N=64
Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)
Carcinoma, Renal Cell
Bottom Line
View on ClinicalTrials.gov: NCT00569946 ↗Enrolled (actual)
64
Serious AEs
32.8%
Results posted
Mar 2012
Primary outcome: Primary: Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment — 50.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AG-013736 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment |
50.0 | — |
| PRIMARY Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment |
54.7 | — |
| SECONDARY Progression-Free Survival (PFS) |
11.0; 12.0 | — |
| SECONDARY Time to Tumor Progression (TTP) |
11.0; 12.0 | — |
| SECONDARY Duration of Response |
11.1; 12.8 | — |
| SECONDARY Overall Survival (OS) |
37.3 | — |
| SECONDARY Number of Participants Analyzed for Population Pharmacokinetics of AG-013736 |
— | — |
| SECONDARY Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1) |
83.10; 63.60; 68.20; 69.20; 62.90; 62.00 | — |
| SECONDARY Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2) |
8900.0; 6040.0; 5980.0; 6030.0; 5880.0; 5790.0 | — |
| SECONDARY Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3) |
20250.0; 12000.0; 13100.0; 13800.0; 16700.0; 15550.0 | — |
| SECONDARY Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT) |
39050.0; 35000.0; 37300.0; 38100.0; 39800.0; 41400.0 | — |
| SECONDARY Plasma Concentration of Vascular Endothelial Growth Factor (VEGF) |
63.40; 162.00; 137.00; 145.00; 155.00; 184.50 | — |
| SECONDARY Number of Participants With Adverse Events |
64; 21; 58; 1; 16 | — |
Summary
To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)
Eligibility Criteria
Inclusion Criteria
- Patients histologically diagnosed as metastatic renal cell cancer with a component of clear cell cancer.
- Patients who are refractory to cytokine therapy as 1st line.
- Patients who experienced nephrectomy.
- Patients with at least 1 target lesion, as defined by RECIST.
- Patients with no uncontrolled hypertension.
Exclusion Criteria
- Gastrointestinal abnormalities
- Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4 inducers.
- Active seizure disorder or evidence of brain metastases.
- Patients with hemoptysis.
Data sourced from ClinicalTrials.gov (NCT00569946). 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.