A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.

Study Overview
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Brief Summary
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To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma

Official Title
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A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Drug: SU011248


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cytokine refractory metastatic renal cell carcinoma with clear cell component Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy Prior nephrectomy Exclusion Criteria: Prior treatment with any systemic therapy other than 1 cytokine therapy History of or known brain metastases Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SU011248<br>* 50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity<br>* Other names: Sunitinib, SUTENT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) | Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tumor Progression (TTP) | Time in weeks 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) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]). | From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter | 
| Duration of Response (DR) | Time in weeks 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) divided by 7. DR was calculated for the subgroup of patients with a confirmed objective tumor response. | Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer | 
| Overall Survival (OS) | Time in weeks 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) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death). | From start of study treatment until death | 
| Progression-free Survival (PFS) | Time in weeks 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) divided by 7. 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). | From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death | 
| Percent Chance of Patient Survival | Probability of survival 1 year and 2 years after the first dose of study treatment | From start of study treatment until death | 
| Observed Plasma Trough Concentrations of Sunitinib | Observed plasma trough (predose) (Cmin) concentrations of sunitinib | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | 
| Observed Plasma Trough Concentrations of Sunitinib Metabolite | Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662) | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | 
| Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662) | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | 
| Dose Corrected Plasma Trough Concentrations of Sunitinib | Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date. | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | 
| Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date. | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | 
| Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date. | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater |