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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SU011248

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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]).

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.

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).

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").

Percent Chance of Patient Survival

Probability of survival 1 year and 2 years after the first dose of study treatment

Observed Plasma Trough Concentrations of Sunitinib

Observed plasma trough (predose) (Cmin) concentrations of sunitinib

Observed Plasma Trough Concentrations of Sunitinib Metabolite

Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)

Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite

Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)

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.

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.

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.

Full Information

NCT ID

NCT00077974

First Posted

February 13, 2004

Last Updated

October 8, 2010

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00077974

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Renal Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SU011248

Other Intervention Name(s)

Sunitinib, SUTENT

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)

Description

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.

Time Frame

From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

Secondary Outcome Measure Information:

Title

Time to Tumor Progression (TTP)

Description

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]).

Time Frame

From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

Title

Duration of Response (DR)

Description

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.

Time Frame

Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer

Title

Overall Survival (OS)

Description

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).

Time Frame

From start of study treatment until death

Title

Progression-free Survival (PFS)

Description

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").

Time Frame

From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death

Title

Percent Chance of Patient Survival

Description

Probability of survival 1 year and 2 years after the first dose of study treatment

Time Frame

From start of study treatment until death

Title

Observed Plasma Trough Concentrations of Sunitinib

Description

Observed plasma trough (predose) (Cmin) concentrations of sunitinib

Time Frame