Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment
Primary Purpose
Renal Cell Carcinoma
Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Axitinib
Sponsored by
About this trial
This is an expanded access trial for Renal Cell Carcinoma focused on measuring Axitinib, metastatic renal cell carcinoma
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01473043
Brief Title
Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment
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 Type
Expanded Access
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
No longer available
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Axitinib, metastatic renal cell carcinoma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Axitinib
Other Intervention Name(s)
AG-013736
Intervention Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Pfizer Investigational Site
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Wendouree
State/Province
Victoria
ZIP/Postal Code
3355
Country
Australia
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061061&StudyName=Clinical%20Study%20With%20Axitinib%20In%20Advanced%20Kidney%20Cancer%2C%20Who%20Have%20Failed%20First%20Line%20Treatment%20
Description
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Learn more about this trial
Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment
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