Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma

NCT00076011 | Completed Phase 2 Results

• 1 other identifier: A4061012
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 9

Brief Summary

The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.

Conditions

Kidney Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response (OR)

  Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

  Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks

Secondary Outcomes (4)

• Time to Disease Progression (TTP)

  Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks

• Duration of Response (DR)

  Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks

• Overall Survival (OS)

  Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant

• Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score

  Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose

Other Outcomes (1)

• Population Pharmacokinetics of Axitinib (AG-013736)

  Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks

Interventions

Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor DRUG

Eligibility Criteria

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

You may qualify if:

• Histologically documented RCC with metastases.
• Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to disease progression or unacceptable treatment-related toxicity

You may not qualify if:

• Any prior systemic treatment for Renal Cell Carcinoma \[RCC\] other than 1 prior cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or an anti-angiogenesis agent are not allowed.
• Inability to take oral medication

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

Pfizer Investigational Site

Paris, Paris, 75651, France

Location

Pfizer Investigational Site

Hanover, 30625, Germany

Location

Related Publications (1)

• Rixe O, Bukowski RM, Michaelson MD, Wilding G, Hudes GR, Bolte O, Motzer RJ, Bycott P, Liau KF, Freddo J, Trask PC, Kim S, Rini BI. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol. 2007 Nov;8(11):975-84. doi: 10.1016/S1470-2045(07)70285-1. Epub 2007 Oct 23.

  PMID: 17959415 DERIVED

Related Links

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

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Receptors, Vascular Endothelial Growth Factor; Receptors, Platelet-Derived Growth Factor

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Receptor Protein-Tyrosine Kinases; Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins; Receptors, Growth Factor; Receptors, Peptide

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2004
• First Posted: January 14, 2004
• Study Start: October 1, 2003
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: June 26, 2012
• Results First Posted: March 19, 2012

Record last verified: 2012-06

Locations

FR (1); DE (1); US (7)