A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00077974
First received: February 13, 2004
Last updated: October 8, 2010
Last verified: October 2010
  Purpose

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: SU011248
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: A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) [ Time Frame: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter ] [ Designated as safety issue: No ]
    Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.


Secondary Outcome Measures:
  • Time to Tumor Progression (TTP) [ Time Frame: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter ] [ Designated as safety issue: No ]
    Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).

  • Duration of Response (DR) [ Time Frame: Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer ] [ Designated as safety issue: No ]

    Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.

    DR was calculated for the subgroup of patients with a confirmed objective tumor response.


  • Overall Survival (OS) [ Time Frame: From start of study treatment until death ] [ Designated as safety issue: No ]
    Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).

  • Progression-free Survival (PFS) [ Time Frame: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death ] [ Designated as safety issue: No ]
    Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

  • Percent Chance of Patient Survival [ Time Frame: From start of study treatment until death ] [ Designated as safety issue: No ]
    Probability of survival 1 year and 2 years after the first dose of study treatment

  • Observed Plasma Trough Concentrations of Sunitinib [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
    Observed plasma trough (predose) (Cmin) concentrations of sunitinib

  • Observed Plasma Trough Concentrations of Sunitinib Metabolite [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
    Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)

  • Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
    Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)

  • Dose Corrected Plasma Trough Concentrations of Sunitinib [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
    Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.

  • Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
    Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.

  • Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
    Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.


Enrollment: 106
Study Start Date: February 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: SU011248
50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
Other Name: Sunitinib, SUTENT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cytokine refractory metastatic renal cell carcinoma with clear cell component
  • Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
  • Prior nephrectomy

Exclusion Criteria:

  • Prior treatment with any systemic therapy other than 1 cytokine therapy
  • History of or known brain metastases
  • Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start
  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: NCT00077974

Locations
United States, California
Pfizer Investigational Site
Duarte, California, United States, 91010-3000
Pfizer Investigational Site
Pasadena, California, United States, 91105
Pfizer Investigational Site
San Francisco, California, United States, 94115
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10022
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27705
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97213
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00077974     History of Changes
Obsolete Identifiers: NCT00082849
Other Study ID Numbers: A6181006
Study First Received: February 13, 2004
Results First Received: September 25, 2009
Last Updated: October 8, 2010
Health Authority: United States: Food and Drug Administration

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 28, 2014