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

• Conditions: Renal Cell Carcinoma

• Registration Number: NCT01473043
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Study Start: 2012-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Montreal, Quebec, Canada