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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077974
• Other study ID #: A6181006
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2004
• Last updated: October 8, 2010
• Start date: February 2004
• Est. completion date: September 2008

Study information

• Verified date: October 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00082849

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• SU011248
50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Duarte	California
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Pasadena	California
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Rochester	Minnesota
United States	Pfizer Investigational Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)	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.	From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter	No
Secondary	Time to Tumor Progression (TTP)	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]).	From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter	No
Secondary	Duration of Response (DR)	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.	Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer	No
Secondary	Overall Survival (OS)	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).	From start of study treatment until death	No
Secondary	Progression-free Survival (PFS)	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").	From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death	No
Secondary	Percent Chance of Patient Survival	Probability of survival 1 year and 2 years after the first dose of study treatment	From start of study treatment until death	No
Secondary	Observed Plasma Trough Concentrations of Sunitinib	Observed plasma trough (predose) (Cmin) concentrations of sunitinib	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater	No
Secondary	Observed Plasma Trough Concentrations of Sunitinib Metabolite	Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater	No
Secondary	Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite	Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater	No
Secondary	Dose Corrected Plasma Trough Concentrations of Sunitinib	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.	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater	No
Secondary	Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite	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.	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater	No
Secondary	Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite	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.	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater	No

External Links

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