Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment
NCT ID: NCT01473043
Last Updated: 2014-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
2012-03-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Interventions
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Axitinib
5mg twice daily \[BD\] daily dosing until progression or prohibitive toxicity Dose titration by 2 levels upwards (7mg and 10mg) and downwards (3mg and 2mg) allowed per protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Douglas, Queensland, Australia
Pfizer Investigational Site
Hobart, Tasmania, Australia
Pfizer Investigational Site
Wendouree, Victoria, Australia
Pfizer Investigational Site
Montreal, Quebec, Canada
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4061061
Identifier Type: -
Identifier Source: org_study_id