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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
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Renal Cell Carcinoma focused on measuring Axitinib, metastatic renal cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 14, 2011
Last Updated
May 28, 2014
Sponsor
Pfizer
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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
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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