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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01473043
First received: November 14, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 Intervention
Renal Cell Carcinoma
Drug: Axitinib

Study Type: Expanded Access     What is 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Study Start Date: March 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473043

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01473043     History of Changes
Other Study ID Numbers: A4061061
Study First Received: November 14, 2011
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Axitinib
metastatic renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014