Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Axitinib

Angiogenesis Inhibitors

Endothelial Growth Factors

Mitogens

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

Pfizer CT.gov Call Center

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.

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

Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer

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.

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.

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 \[PD\]).

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.

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.

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.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Age Continuous

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.

Percentage of Participants With Objective Response (OR)

Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.

Time to Disease Progression (TTP)

Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).

Duration of Response (DR)

Study population included all participants who received at least 1 dose of study medication.

Overall Survival (OS)

Global health status: Baseline (n=52)

Global health status: Change at Day 29 (n=46)

Global health status: Change at Day 57 (n=33)

Global health status: Change at Day 113 (n=41)

Global health status: Change at Day 169 (n=32)

Global health status: Change at Day 225 (n=28)

Global health status: Change at Day 281 (n=22)

Global health status: Change at Day 337 (n=14)

Global health status: Change at Day 393 (n=19)

Global health status: Change at Day 449 (n=16)

Global health status: Change at Day 505 (n=19)

Global health status: Change at Day 561 (n=16)

Global health status: Change at Day 617 (n=14)

Global health status: Change at Day 673 (n=11)

Global health status: Change at Day 729 (n=11)

Global health status: Change at Day 785 (n=10)

Global health status: Change at Day 841 (n=4)

Global health status: Change at Day 897 (n=1)

Global health status: Change at Day 953 (n=1)

Global health status: Change at follow-up (n=12)

Physical functioning: Baseline (n=52 )

Physical functioning: Change at Day 29 (n=47)

Physical functioning: Change at Day 57 (n=45)

Physical functioning: Change at Day 113 (n=41)

Physical functioning: Change at Day 169 (n=32)

Physical functioning: Change at Day 225 (n=28)

Physical functioning: Change at Day 281 (n=23)

Physical functioning: Change at Day 337 (n=14)

Physical functioning: Change at Day 393 (n=19)

Physical functioning: Change at Day 449 (n=17)

Physical functioning: Change at Day 505 (n=20)

Physical functioning: Change at Day 561 (n=17)

Physical functioning: Change at Day 617 (n=14)

Physical functioning: Change at Day 673 (n=11)

Physical functioning: Change at Day 729 (n=11)

Physical functioning: Change at Day 785 (n=10)

Physical functioning: Change at Day 841 (n=5)

Physical functioning: Change at Day 897 (n=1)

Physical functioning: Change at Day 953 (n=1)

Physical functioning: Change at follow-up (n=12)

Role functioning: Baseline (n=52 )

Role functioning: Change at Day 29 (n=47)

Role functioning: Change at Day 57 (n=45)

Role functioning: Change at Day 113 (n=41)

Role functioning: Change at Day 169 (n=32)

Role functioning: Change at Day 225 (n=28)

Role functioning: Change at Day 281 (n=23)

Role functioning: Change at Day 337 (n=14)

Role functioning: Change at Day 393 (n=19)

Role functioning: Change at Day 449 (n=16)

Role functioning: Change at Day 505 (n=20)

Role functioning: Change at Day 561 (n=17)

Role functioning: Change at Day 617 (n=14)

Role functioning: Change at Day 673 (n=11)

Role functioning: Change at Day 729 (n=11)

Role functioning: Change at Day 785 (n=10)

Role functioning: Change at Day 841 (n=5)

Role functioning: Change at Day 897 (n=1)

Role functioning: Change at Day 953 (n=1)

Role functioning: Change at follow-up (n=12)

Emotional functioning: Baseline (n=52)

Emotional functioning: Change at Day 29 (n=46)

Emotional functioning: Change at Day 57 (n=33)

Emotional functioning: Change at Day 113 (n=41)

Emotional functioning: Change at Day 169 (n=32)

Emotional functioning: Change at Day 225 (n=28)

Emotional functioning: Change at Day 281 (n=23)

Emotional functioning: Change at Day 337 (n=14)

Emotional functioning: Change at Day 393 (n=19)

Emotional functioning: Change at Day 449 (n=16)

Emotional functioning: Change at Day 505 (n=19)

Emotional functioning: Change at Day 561 (n=17)

Emotional functioning: Change at Day 617 (n=14)

Emotional functioning: Change at Day 673 (n=11)

Emotional functioning: Change at Day 729 (n=11)

Emotional functioning: Change at Day 785 (n=10)

Emotional functioning: Change at Day 841 (n=4)

Emotional functioning: Change at Day 897 (n=1)

Emotional functioning: Change at Day 953 (n=1)

Emotional functioning: Change at follow-up (n=12)

Cognitive Functioning: Baseline (n=52)

Cognitive Functioning: Change at Day 29 (n=46)

Cognitive Functioning: Change at Day 57 (n=33)

Cognitive Functioning: Change at Day 113 (n=41)

Cognitive Functioning: Change at Day 169 (n=32)

Cognitive Functioning: Change at Day 225 (n=28)

Cognitive Functioning: Change at Day 281 (n=23)

Cognitive Functioning: Change at Day 337 (n=14)

Cognitive Functioning: Change at Day 393 (n=19)

Cognitive Functioning: Change at Day 449 (n=16)

Cognitive Functioning: Change at Day 505 (n=19)

Cognitive Functioning: Change at Day 561 (n=17)

Cognitive Functioning: Change at Day 617 (n=14)

Cognitive Functioning: Change at Day 673 (n=11)

Cognitive Functioning: Change at Day 729 (n=11)

Cognitive Functioning: Change at Day 785 (n=10)

Cognitive Functioning: Change at Day 841 (n=4)

Cognitive Functioning: Change at Day 897 (n=1)

Cognitive Functioning: Change at Day 953 (n=1)

Cognitive Functioning: Change at follow-up (n=12)

Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease. The 'n' is signifying those participants who were evaluable for this measure at the specified time point.

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

Population Pharmacokinetics of Axitinib (AG-013736)

Overall Study

Spots Global Cancer Trial Database for Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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