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

Renal Cell Carcinoma Clinical Trial

Official title:

Clinical Study With Axitinib (AG 013736) In Patients With Metastatic Renal Cell Carcinoma After Failure Of One Prior Systemic First-Line Therapy

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01473043
• Other study ID #: A4061061
• Status: No longer available
• Phase: N/A
• First received: November 14, 2011
• Last updated: May 28, 2014
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Douglas	Queensland
Australia	Pfizer Investigational Site	Hobart	Tasmania
Australia	Pfizer Investigational Site	Wendouree	Victoria
Canada	Pfizer Investigational Site	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Canada, 

External Links

•   To obtain contact information for a study center near you, click here.