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Trial record 1 of 1 for:    A6181072
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Study of SU011248 in Patients With Advanced Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00254540
Recruitment Status : Completed
First Posted : November 16, 2005
Results First Posted : February 11, 2010
Last Update Posted : February 23, 2010
Sponsor:
Information provided by:
Pfizer

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).

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: SU011248 capsule Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma
Study Start Date : December 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009


Arm Intervention/treatment
Experimental: SU-011248 capsule Drug: SU011248 capsule
50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops




Primary Outcome Measures :
  1. Number of Subjects With Objective Response [ Time Frame: Day 28 of Cycles 1-4 ]
    Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.


Secondary Outcome Measures :
  1. 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. ]
    Progression-free survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD) or death.

  2. 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. ]
    Time to tumor progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD).

  3. 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. ]
    Duration of response (DR) is defined as the period between the day of initial confirmation of complete response (CR) or partial response (PR) and the day of initial confirmation of progressive disease (PD) or death of any cause. For subjects who were not confirmed to have PD or death of any cause during the study (including 28 days after the completion of study treatment) or before the initiation of another antitumor therapy, DR was censored on the final confirmation of progression-free condition during the study.

  4. 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. ]
    Time to tumor response (TTR) is defined as the period between the day of initial study treatment and the day of initial confirmation of complete response (CR) or partial response (PR). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

  5. Overall Survival Time [ Time Frame: once year. Up to 3 years after the completion of subject registration. ]
    Overall survival time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, overall survival time was censored on the last date when the subject was known to be alive.

  6. 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 ]
    Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline. The EQ-5D evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale (1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index (Range: 0 to 1). High score is indicating high health.

  7. 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 ]

    Change from Baseline: weighted health state VAS score at each observation minus weighted health state VAS score at baseline.

    The VAS is a self-completed scale designed to rate the subject's current health state from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.


  8. 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 ]
    Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration

  9. 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 ]
    Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.

  10. 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 ]
    SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration

  11. 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 ]
    SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration

  12. 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 ]

    SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.

    The Ctrough for total drug (SU-011248+SU-012662) was calculated as the mean of the Ctrough of total drug from each individual subject.


  13. 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 ]

    SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.

    The Ctrough for total drug (SU011248+SU012662) was calculated as the mean of the Ctrough of total drug from each individual subject.


  14. 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 ]
    Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)

  15. 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 ]
    Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254540


Locations
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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
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00254540    
Other Study ID Numbers: A6181072
First Posted: November 16, 2005    Key Record Dates
Results First Posted: February 11, 2010
Last Update Posted: February 23, 2010
Last Verified: February 2010
Keywords provided by Pfizer:
Ph2, RCC, SU011248, SUNITINIB
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action