Study of SU011248 in Patients With Advanced Kidney Cancer

Carcinoma, Renal Cell Clinical Trial

Official title:

Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254540
• Other study ID #: A6181072
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2005
• Last updated: February 17, 2010
• Start date: December 2005
• Est. completion date: February 2009

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

Drug:
• SU011248 capsule
50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Akita
Japan	Pfizer Investigational Site	Chuo-ku	Tokyo
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Hamamatsu	Shizuoka
Japan	Pfizer Investigational Site	Osaka
Japan	Pfizer Investigational Site	Osakasayama	Osaka
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Sunto-gun	Shizuoka
Japan	Pfizer Investigational Site	Tokushima
Japan	Pfizer Investigational Site	Tsukuba	Ibaragi
Japan	Pfizer Investigational Site	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Objective Response		Day 28 of Cycles 1-4	No
Secondary	Progression-Free Survival (PFS)		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.	No
Secondary	Time To Tumor Progression (TTP)		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.	No
Secondary	Duration of Response (DR)		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.	No
Secondary	Time to Tumor Response (TTR)		Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.	No
Secondary	Overall Survival Time		once year. Up to 3 years after the completion of subject registration.	No
Secondary	Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score		Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4	No
Secondary	Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)		Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4	No
Secondary	Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population		Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3	No
Secondary	Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population		Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3	No
Secondary	Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population		Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3	No
Secondary	Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population		Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3	No
Secondary	Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population		Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3	No
Secondary	Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population		Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3	No
Secondary	Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)		Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3	No
Secondary	Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)		Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3	No

External Links

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