Status:
NO_LONGER_AVAILABLE
Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment
Lead Sponsor:
Pfizer
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
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 countr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
EXPANDED_ACCESS
End Date :
March 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01473043
Start Date
March 1 2012
End Date
March 1 2014
Last Update
May 30 2014
Active Locations (4)
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1
Pfizer Investigational Site
Douglas, Queensland, Australia, 4814
2
Pfizer Investigational Site
Hobart, Tasmania, Australia, 7000
3
Pfizer Investigational Site
Wendouree, Victoria, Australia, 3355
4
Pfizer Investigational Site
Montreal, Quebec, Canada, H2X 1N8