Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment

Pfizer

Status

Conditions: Renal Cell Carcinoma

Treatments: Drug: Axitinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01473043

A4061061

Details and patient eligibility

About

This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. The study will recruit a maximum of 30 patients from 2 countries including Australia and Canada. Patients will be followed up for efficacy, safety and health related outcomes.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metastatic renal cell carcinoma with a component of clear cell subtype.
• Prior first line systemic therapy
• At least 1 measurable lesion as per Response Evaluation Criterion in Solid Tumors [RECIST 1.1].
• Adequate hematology, liver and kidney functions
• Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1.
• Life expectancy of ≥12 weeks.
• Normotensive or well controlled hypertension (less than/equal to 140/90 mm Hg.)
• Negative pregnancy test
• Adequate recovery time from prior systemic therapy, surgery or radiation
• Willing and able subjects who have signed consent

Exclusion criteria

• More than one prior systemic therapy regimen
• Major bowel-penetrating surgery <4 weeks
• Active gastro intestinal bleed in past 3 months
• Active peptic ulcer disease in the past 6 months
• Current or anticipated use of potent CYP3A4/5 inhibitors
• Current or anticipated use of known CYP3A4/5 or CYP1A2 inducers
• Requirement for therapeutic warfarin or high dose steroids
• Symptomatic or untreated brain metastases
• A serious uncontrolled medical disorder or active infection
• Pregnant or breastfeeding females
• History of another active malignancy
• Dementia