A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
- Registration Number
- NCT00077974
- Lead Sponsor
- Pfizer
- Brief Summary
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 SU011248 -
- Primary Outcome Measures
Name Time Method Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter 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.
- Secondary Outcome Measures
Name Time Method Time to Tumor Progression (TTP) From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter 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 \[PD\]).
Duration of Response (DR) Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer 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.Overall Survival (OS) From start of study treatment until death 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).
Progression-free Survival (PFS) From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death 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").
Percent Chance of Patient Survival From start of study treatment until death Probability of survival 1 year and 2 years after the first dose of study treatment
Observed Plasma Trough Concentrations of Sunitinib Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater Observed plasma trough (predose) (Cmin) concentrations of sunitinib
Observed Plasma Trough Concentrations of Sunitinib Metabolite Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)
Dose Corrected Plasma Trough Concentrations of Sunitinib Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater 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.
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater 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.
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Madison, Wisconsin, United States