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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01473043
Recruitment Status : No longer available
First Posted : November 17, 2011
Last Update Posted : May 30, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Renal Cell Carcinoma Drug: Axitinib

Study Type : Expanded Access
Official Title: Clinical Study With Axitinib (AG 013736) In Patients With Metastatic Renal Cell Carcinoma After Failure Of One Prior Systemic First-Line Therapy
Study Start Date : March 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib
U.S. FDA Resources

Intervention Details:
    Drug: 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 Name: AG-013736

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01473043

Australia, Queensland
Pfizer Investigational Site
Douglas, Queensland, Australia, 4814
Australia, Tasmania
Pfizer Investigational Site
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Pfizer Investigational Site
Wendouree, Victoria, Australia, 3355
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2X 1N8
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01473043     History of Changes
Other Study ID Numbers: A4061061
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

Keywords provided by Pfizer:
metastatic renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action