Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

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

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity

SU011248

Pfizer CT.gov Call Center

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

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

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

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.

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 \[PD\]).

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.

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).

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").

Probability of survival 1 year and 2 years after the first dose of study treatment

Observed plasma trough (predose) (Cmin) concentrations of sunitinib

Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)

Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)

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 (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 (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.

Pfizer

Director, Clinical Trial Disclosure Group

50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Sunitinib Malate

< 65 years

>= 65 years

Age, Customized

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

The intent-to-treat (ITT) population included all subjects who enrolled in the study that received at least 1 dose of study medication. This was the primary population for all efficacy analyses and safety analyses.

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)

Time to Tumor Progression (TTP)

ITT subgroup of patients with a confirmed objective tumor response

Duration of Response (DR)

Overall Survival (OS)

Progression-free Survival (PFS)

1 year

2 years

Percent Chance of Patient Survival

Cycle 1 Day 28 (n = 103)

Cycle 2 Day 28 (n = 81)

Cycle 3 Day 28 (n = 73)

Cycle 4 Day 28 (n = 66)

Cycle 5 Day 1 (n = 63)

Cycle 6 Day 1 (n = 59)

Cycle 7 Day 1 (n = 52)

Cycle 8 Day 1 (n = 48)

Cycle 9 Day 1 (n = 46)

Cycle 10 Day 1 (n = 41)

Cycle 11 Day 1 (n = 38)

Cycle 12 Day 1 (n = 34)

Cycle 13 Day 1 (n = 30)

Cycle 14 Day 1 (n = 30)

Cycle 15 Day 1 (n = 24)

Cycle 16 Day 1 (n = 24)

Cycle 17 Day 1 (n = 19)

Cycle 18 Day 1 (n = 16)

Cycle 19 Day 1 (n = 14)

Cycle 20 Day 1 (n = 12)

Cycle 21 Day 1 (n = 11)

Cycle 22 Day 1 (n = 11)

Cycle 23 Day 1 (n = 7)

Cycle 24 Day 1 (n = 7)

Cycle 25 Day 1 (n = 6)

Cycle 26 Day 1 (n = 6)

Cycle 27 Day 1 (n = 6)

Cycle 28 Day 1 (n = 4)

Cycle 29 Day 1 (n = 5)

Cycle 30 Day 1 (n = 4)

Observed Plasma Trough Concentrations of Sunitinib

Observed Plasma Trough Concentrations of Sunitinib Metabolite

Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite

Cycle 1 Day 28 (n = 33)

Cycle 2 Day 28 (n = 26)

Cycle 3 Day 28 (n = 20)

Cycle 4 Day 28 (n = 25)

Cycle 5 Day 1 (n = 28)

Cycle 6 Day 1 (n = 41)

Cycle 7 Day 1 (n = 35)

Cycle 8 Day 1 (n = 32)

Cycle 9 Day 1 (n = 32)

Cycle 10 Day 1 (n = 32)

Cycle 11 Day 1 (n = 25)

Cycle 12 Day 1 (n = 28)

Cycle 13 Day 1 (n = 23)

Cycle 14 Day 1 (n = 24)

Cycle 15 Day 1 (n = 16)

Cycle 16 Day 1 (n = 18)

Cycle 17 Day 1 (n = 17)

Cycle 18 Day 1 (n = 14)

Cycle 19 Day 1 (n = 11)

Cycle 20 Day 1 (n = 11)

Cycle 21 Day 1 (n = 8)

Cycle 22 Day 1 (n = 9)

Cycle 23 Day 1 (n = 6)

Cycle 24 Day 1 (n = 6)

Cycle 25 Day 1 (n = 5)

Cycle 26 Day 1 (n = 5)

Cycle 27 Day 1 (n = 5)

Cycle 29 Day 1 (n = 4)

Cycle 30 Day 1 (n = 3)

Dose Corrected Plasma Trough Concentrations of Sunitinib

Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite

Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite

Overall Study

Spots Global Cancer Trial Database for A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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