Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: axitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00835978

2008-007786-23 (EudraCT Number)

A4061046

Details and patient eligibility

About

Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• metastatic renal cell carcinoma (kidney cancer) with clear cell component
• no prior systemic therapy (including no prior adjuvant or neoadjuvant)
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Blood Pressure < or = 140/90mmHg

Exclusion criteria

• brain/CNS metastasis
• using more than 2 blood pressure medications

Trial design

213 participants in 3 patient groups

A

Other group

Description:

Randomized arm

Treatment:

Drug: axitinib

Drug: axitinib

Drug: axitinib

B

Other group

Description:

Randomized arm

Treatment:

Drug: axitinib

Drug: axitinib

Drug: axitinib

C

Other group

Description:

Non-randomized arm

Treatment:

Drug: axitinib

Drug: axitinib

Drug: axitinib