| January 23, 2006 |
| November 6, 2009 |
| March 2006 |
| February 2009 (final data collection date for primary outcome measure) |
- Measured by overall objective response rate, CR and PR, by RECIST. [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
- To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
|
| To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer as measured by overall objective response rate, CR and PR, by RECIST. |
| Complete list of historical versions of study NCT00282048 on ClinicalTrials.gov Archive Site |
- Progression-free survival [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
- Explore effects of treatment on patient reported outcomes [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
- Cancer related symptoms (FKSI) [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
- Explore PK correlates with response or adverse events. [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
- Safety profile of AG-013736 [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
|
| Safety profile of AG-013736; progression-free survival, duration of response; overall survival; explore effects of treatment on patient reported outcomes; cancer related symptoms (FKSI); explore PK correlates with response or adverse events. |
| |
| Study of AG-013736 in Patients With Refractory Metastatic Renal Cell Cancer |
| Phase 2 Study of AG-013736 in Patients With Refractory Metastatic Renal Cell Cancer |
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). |
| |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
- Kidney Neoplasms
- Carcinoma, Renal Cell
|
| Drug: AG-013736 (axitinib) |
| Experimental: AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity |
| |
| |
| Completed |
| 62 |
| August 2009 |
| February 2009 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00282048 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| A4061023 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| November 2009 |
