A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00077974
First received: February 13, 2004
Last updated: October 8, 2010
Last verified: October 2010
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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
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 May 23, 2013