Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell; Kidney Neoplasms

Treatments: Drug: AG-013736 (axitinib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00282048

A4061023

Details and patient eligibility

About

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).

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

62 participants in 1 patient group

AG-013736 (axitinib)

Experimental group

Description:

AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity

Treatment:

Drug: AG-013736 (axitinib)