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
  Purpose

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).


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: SU011248 capsule
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Subjects With Objective Response [ Time Frame: Day 28 of Cycles 1-4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 51
Study Start Date: December 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SU-011248 capsule Drug: SU011248 capsule
50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254540

Locations
Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Tsukuba, Ibaragi, Japan
Pfizer Investigational Site
Osakasayama, Osaka, Japan
Pfizer Investigational Site
Hamamatsu, Shizuoka, Japan
Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Pfizer Investigational Site
Akita, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Osaka, Japan
Pfizer Investigational Site
Tokushima, Japan
Pfizer Investigational Site
Yamagata, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00254540     History of Changes
Other Study ID Numbers: A6181072
Study First Received: November 14, 2005
Results First Received: January 15, 2010
Last Updated: February 17, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Ph2, RCC, SU011248, SUNITINIB

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014