Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)

• Status: Completed
• Trial end date: 2012-10-30
• Target enrollment: 0
• Participant gender: All

Summary

To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Axitinib

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.