Clinical trial · Interventional
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
NCT00282048CI-TRIAL-00007641completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AG-013736 (axitinib) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AG-013736 (axitinib)
- description
- AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity
- interventionNames
- Drug: AG-013736 (axitinib)
Primary outcomes (1)
- measure
- Percentage of Participants With Objective Response (OR)
- timeFrame
- Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
- description
- Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of responses. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.