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

• Status: No longer available
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Axitinib

Criteria

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