Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

Antineoplastic Agents

All Drugs and Chemicals

Axitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity

AG-013736 5 mg twice daily \[bid\] continuous dosing in 28 day cycles.

AG-013736 (axitinib)

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To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).

Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer

Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer

FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.

AUCss: pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods, computed as each participant's average total daily dose (accounting for dose reductions and any recorded missed doses) divided by population estimated posthoc individual apparent clearance (CL/F), i.e., AUCss = Daily Dose/(CL/F), where F refers to the oral bioavailability, and CL refers to the systemic clearance. PR: responses with at least 30% decrease in sum of longest dimensions of target lesions using baseline (pre-treatment) sum of longest dimensions as reference. Logistic regression with general linear model was applied to data of PR using AUCss; PR was correlated with AUCss as fold increase in odds of PR with increase in AUCss. Fold increase was calculated as exponent of product of logistic regression slope coefficient and unit change of AUCss.

AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. PFS is median time from first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Relationship of PFS versus AUCss was determined as median PFS in participants with high AUCss \[AUCss greater than or equal to (\>=) median AUCss\] or low AUCss \[AUCss less than (\<) median AUCss\].

AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. OS is time in weeks from the start of study treatment to date of death due to any cause. Relationship of OS versus AUCss was determined as median OS in participants with high AUCss \[AUCss \>= median AUCss\] or low AUCss \[AUCss \< median AUCss\].

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 responses. 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 of longest dimensions.

Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS 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 \[PD\]), or from adverse event (AE) data (where the outcome was "Death").

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 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.

FKSI-DRS is a subset of FKSI which is a questionnaire for FACT -Kidney Symptom Index used to assess Quality of Life (QoL)/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.

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.

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 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.

Age Continuous

Sex: Female, Male

Population pharmacokinetics was not presented, as the data was not available for the single study and data of other axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.

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Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.

Percentage of Participants With Objective Response (OR)

ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.

Progression-free Survival (PFS)

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

Duration of Response (DR)

Overall Survival (OS)

Baseline (n=62)

Day 1 (Cycle 2) (n=52)

Day 1 (Cycle 3) (n=46)

Day 1 (Cycle 4) (n=41)

Day 1 (Cycle 5) (n=39)

Day 1 (Cycle 6) (n=33)

Day 1 (Cycle 7) (n=32)

Day 1 (Cycle 8) (n=30)

Day 1 (Cycle 9) (n=27)

Day 1 (Cycle 10) (n=19)

Day 1 (Cycle 11) (n=17)

Day 1 (Cycle 12) (n=17)

Day 1 (Cycle 13) (n=16)

Day 1 (Cycle 14) (n=15)

Day 1 (Cycle 15) (n=14)

Day 1 (Cycle 16) (n=14)

Day 1 (Cycle 17) (n=13)

Day 1 (Cycle 18) (n=12)

Day 1 (Cycle 19) (n=9)

Day 1 (Cycle 20) (n=10)

Day 1 (Cycle 21) (n=11)

Day 1 (Cycle 22) (n=10)

Day 1 (Cycle 23) (n=9)

Day 1 (Cycle 24) (n=8)

Day 1 (Cycle 25) (n=7)

Day 1 (Cycle 26) (n=7)

Day 1 (Cycle 27) (n=7)

Day 1 (Cycle 28) (n=5)

Day 1 (Cycle 29) (n=6)

Day 1 (Cycle 30) (n=6)

Day 1 (Cycle 31) (n=4)

Day 1 (Cycle 32) (n=1)

Day 1 (Cycle 33) (n=1)

Day 1 (Cycle 34) (n=0)

Day 1 (Cycle 35) (n=1)

Day 1 (Cycle 36) (n=1)

Day 1 (Cycle 37) (n=1)

Day 1 (Cycle 38) (n=1)

at Follow Up (n=9)

ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.

Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score

Population Pharmacokinetics of Axitinib (AG-013736)

At Follow Up (n=9)

Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index (FKSI) Score

Fold change per 1 ng*hr/mL: Cycle1

Fold change per 100 ng*hr/mL: Cycle1

Participants for whom both Pharmacokinetic (PK) and PR data were available were included in analysis.

Correlation of Area Under the Concentration-time Curve at Steady State (AUCss) With Confirmed Partial Response (PR)

PFS at Low AUCss: Cycle1 (n=28)

PFS at High AUCss: Cycle1 (n=29)

Participants for whom both PK and PFS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.

Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Progression-free Survival (PFS)

OS at Low AUCss: Cycle1 (n=28)

OS at High AUCss: Cycle1 (n=29)

Participants for whom both PK and OS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.

Spots Global Cancer Trial Database for Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer

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Study Description

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