Study of SU011248 in Patients With Advanced Kidney Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00254540
First received: November 14, 2005
Last updated: February 17, 2010
Last verified: February 2010

November 14, 2005
February 17, 2010
December 2005
February 2009   (final data collection date for primary outcome measure)
Number of Subjects With Objective Response [ Time Frame: Day 28 of Cycles 1-4 ] [ Designated as safety issue: No ]
Efficacy
Complete list of historical versions of study NCT00254540 on ClinicalTrials.gov Archive Site
  • Progression-Free Survival (PFS) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Time To Tumor Progression (TTP) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Duration of Response (DR) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Time to Tumor Response (TTR) [ Time Frame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. ] [ Designated as safety issue: No ]
  • Overall Survival Time [ Time Frame: once year. Up to 3 years after the completion of subject registration. ] [ Designated as safety issue: No ]
  • Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score [ Time Frame: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4 ] [ Designated as safety issue: No ]
  • Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS) [ Time Frame: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4 ] [ Designated as safety issue: No ]
  • Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population [ Time Frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 ] [ Designated as safety issue: No ]
  • Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population [ Time Frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 ] [ Designated as safety issue: No ]
  • Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population [ Time Frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 ] [ Designated as safety issue: No ]
  • Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population [ Time Frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 ] [ Designated as safety issue: No ]
  • Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population [ Time Frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 ] [ Designated as safety issue: No ]
  • Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population [ Time Frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 ] [ Designated as safety issue: No ]
  • Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 ] [ Designated as safety issue: No ]
  • Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2) [ Time Frame: Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 ] [ Designated as safety issue: No ]
Safety, PK, PD, QOL
Not Provided
Not Provided
 
Study of SU011248 in Patients With Advanced Kidney Cancer
Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Renal Cell
Drug: SU011248 capsule
50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops
Experimental: SU-011248 capsule
Intervention: Drug: SU011248 capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00254540
A6181072
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP