Clinical trial NCT00254540: Study of SU011248 in Patients With Advanced Kidney Cancer
Official title: Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Ph2, RCC, SU011248, SUNITINIB
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-16
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).


Eligibility criteria: Inclusion Criteria:

* Histologically proven renal cell carcinoma with metastases with a component of clear cell histology

Exclusion Criteria:

* Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for RCC.

Primary outcomes:
measure: Number of Subjects With Objective Response
timeFrame: Day 28 of Cycles 1-4
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.
measure: Time To Tumor Progression (TTP)
timeFrame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.
measure: Duration of Response (DR)
timeFrame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.
measure: Time to Tumor Response (TTR)
timeFrame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.
measure: Overall Survival Time
timeFrame: once year. Up to 3 years after the completion of subject registration.
measure: Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score
timeFrame: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4
measure: Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)
timeFrame: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4
measure: Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population
timeFrame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
measure: Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population
timeFrame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
measure: Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population
timeFrame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
measure: Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population
timeFrame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
measure: Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population
timeFrame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
measure: Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population
timeFrame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
measure: Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
timeFrame: Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
measure: Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
timeFrame: Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Tsukuba
country: Japan
facility: Pfizer Investigational Site
state: Ibaragi
city: Osakasayama
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Hamamatsu
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Sunto-gun
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Akita
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Tokushima
country: Japan
facility: Pfizer Investigational Site
city: Yamagata
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: