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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

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

NCT ID

NCT01473043

First Posted

November 14, 2011

Last Updated

May 28, 2014

Sponsor

Pfizer

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

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

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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