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

NCT01473043 | Unknown

• 1 other identifier: A4061061
• Study Type: expanded_access
• Target: N/A
• Locations: 2 countries
• Sites: 4

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.

Conditions

Renal Cell Carcinoma

Keywords

Axitinib; metastatic renal cell carcinoma

Interventions

Axitinib DRUG

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

Also known as: AG-013736

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Douglas, Queensland, 4814, Australia

Location

Pfizer Investigational Site

Hobart, Tasmania, 7000, Australia

Location

Pfizer Investigational Site

Wendouree, Victoria, 3355, Australia

Location

Pfizer Investigational Site

Montreal, Quebec, H2X 1N8, Canada

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 17, 2011
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 30, 2014

Record last verified: 2014-05

Locations

CA (1); AU (3)