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

• ClinicalTrials.gov Identifier: NCT00076011
• Recruitment Status: Completed
• First Posted: January 14, 2004
• Results First Posted: March 19, 2012
• Last Update Posted: June 26, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 12, 2004
• First Posted Date: January 14, 2004
• Results First Submitted Date: February 25, 2012
• Results First Posted Date: March 19, 2012
• Last Update Posted Date: June 26, 2012
• Study Start Date: October 2003
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 25, 2012)

Percentage of Participants With Objective Response (OR) [ Time Frame: 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 ]

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.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: February 25, 2012)

• Time to Disease Progression (TTP) [ Time Frame: 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 ]
  Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
• Duration of Response (DR) [ Time Frame: 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 ]
  Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.
• Overall Survival (OS) [ Time Frame: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant ]
  Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event (AE) data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.
• Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score [ Time Frame: 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 ]
  EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.

• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: February 25, 2012)

Population Pharmacokinetics of Axitinib (AG-013736) [ Time Frame: Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks ]

Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma
• Official Title: Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Kidney Neoplasms
• Intervention: Drug: Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor
• Study Arms: Not Provided
• Publications *: 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. Epub 2007 Oct 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 23, 2005): 52
• Original Enrollment: Same as current
• Actual Study Completion Date: February 2007
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, United States

Administrative Information

• NCT Number: NCT00076011
• Other Study ID Numbers: A4061012
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2012