Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00076011
First received: January 12, 2004
Last updated: June 20, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Neoplasms |
Drug: Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 52 |
| Study Start Date: | October 2003 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076011
Locations
| United States, California | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02114 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Madison, Wisconsin, United States, 53792 | |
| France | |
| Pfizer Investigational Site | |
| Paris Cedex 13, Paris, France, 75651 | |
| Germany | |
| Pfizer Investigational Site | |
| Hannover, Germany, 30625 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00076011 History of Changes |
| Obsolete Identifiers: | NCT00077272 |
| Other Study ID Numbers: | A4061012 |
| Study First Received: | January 12, 2004 |
| Results First Received: | February 25, 2012 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Mitogens Angiogenesis Inhibitors Endothelial Growth Factors |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013