Back to resultsStudy Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring brain metastases, Sunitinib, Phase 2
Eligibility Criteria
Inclusion Criteria:
- Patients with radiologically proven brain metastases secondary to non-small cell lung cancer
- Received previous whole brain radiation therapy and none, 1 or 2 prior systemic therapy for the treatment of advanced/metastatic non-small cell lung cancer
Exclusion Criteria:
- Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or leptomeningeal disease.
- Brain metastases >4 cm in any linear direction
- Intracranial or intratumoral hemorrhage
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sunitinib
Arm Description
Outcomes
Primary Outcome Measures
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. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
Secondary Outcome Measures
Time to Tumor Progression (TTP)
Time from start of study treatment to first documentation of objective tumor progression. Tumor progression defined as greater than or equal to 20 percent (≥20%) increase in sum of longest dimensions of target lesions using as reference smallest sum of longest dimensions recorded since treatment started, or unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST). TTP = (first event date minus date of first dose of study medication plus 1) divided by 7.02.
Time to Neurological Progression (TNP)
Time in weeks between first date criteria for focal neurological deficit were met and date of first dose of medication. Criteria for focal neurological deficit included speech or language difficulties, vision changes, loss of coordination or fine motor control, and seizures. Since day of first dose of medication and day criteria for focal neurological deficit were met were each counted as a full day, 1 day was added to each calculation. TNP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.
Number of Participants With Objective Disease Response
Objective disease response defined as participants with confirmed complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.
Time to Objective Intracranial Progression
Time in weeks from start of study treatment to first documentation of objective intracranial tumor progression. Intracranial tumor progression defined as ≥25% increase from smallest size in sum of products of all enhancing tumors or appearance of any new tumor, according to World Health Organization (WHO) criteria. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day added to each calculation. Time to Objective Intracranial Progression = (first event date minus the date of first dose of study medication plus 1) divided by 7.02.
Number of Participants With Intracranial Objective Disease Response
Intracranial objective disease response defined as participants with confirmed CR or PR, according to WHO criteria. CR defined as disappearance of all enhancing tumor. PR defined as a ≥50% reduction from baseline in sum of the products of all enhancing tumors.
Duration of Response (DR)
DR defined as difference in weeks between first date criteria for progression occurred, or participant died due to any cause and first date that criteria for a PR or CR were met and subsequently confirmed ≥4 weeks later. Since day criteria for PR or CR were met and first day criteria for progression occurred (or participant died) were each counted as a full day, 1 day was added to each calculation. DR (in weeks) calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.
Overall Survival (OS)
OS calculated as: (date of death minus date of first dose plus 1)divided by 30.4.
Percentage of Participants Surviving at 1 Year
Percentage of those surviving at end of 1 year from the first dose of study treatment.
Number of Deaths Due to Intracranial Versus Systemic Progression
Number of deaths determined to be intracranial versus systemic progression, according to investigators'assessment.
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score
Change from baseline in FLSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 24. Higher scores indicated better outcomes.
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score
Change from baseline in FBrSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 60. Higher scores indicated better outcomes.
Trough Plasma Concentrations (Ctrough) of Sunitinib
A single blood sample (4 milliliters [mL]) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.
Ctrough of Sunitinib Metabolite (SU012662)
A single blood sample (4 mL) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.
Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts
A blood sample (6mL) collected before treatment with Sunitinib and used to isolate deoxyribonucleic acid (DNA). These samples were not anonymized.
Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile
Tumor samples were not anonymized. RNA expression profile was to include colony-stimulating factor 1 receptor (CSF-1R), platelet-derived growth factor receptor alpha and beta (PDGFRalpha and PDGFRbeta), vascular endothelial growth factor (VEGF), VEGF-C, VEGF receptor 1, 2, and 3 (VEGFR1, VEGFR2, and VEGFR3), fibroblast growth factor (FGF), FMS-like tyrosine kinase 3 (FLT3), KIT (stem cell factor receptor), and RET (rearranged during transfection).
PFS in Subgroups Defined by RNA Expression Profiles of Tumors
PFS defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was to be determined in subgroups defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT3, KIT, and RET) level (low/high relative to expression of Glyceraldehyde-3-Phosphate Dehydrogenase [GAPDH] reference gene). PFS calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00372775
Brief Title
Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases
Official Title
A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
brain metastases, Sunitinib, Phase 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sunitinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent
Intervention Description
Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity
Primary Outcome Measure Information:
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. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
Time Frame
Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)
Secondary Outcome Measure Information:
Title
Time to Tumor Progression (TTP)
Description
Time from start of study treatment to first documentation of objective tumor progression. Tumor progression defined as greater than or equal to 20 percent (≥20%) increase in sum of longest dimensions of target lesions using as reference smallest sum of longest dimensions recorded since treatment started, or unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST). TTP = (first event date minus date of first dose of study medication plus 1) divided by 7.02.
Time Frame
Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year)
Title
Time to Neurological Progression (TNP)
Description
Time in weeks between first date criteria for focal neurological deficit were met and date of first dose of medication. Criteria for focal neurological deficit included speech or language difficulties, vision changes, loss of coordination or fine motor control, and seizures. Since day of first dose of medication and day criteria for focal neurological deficit were met were each counted as a full day, 1 day was added to each calculation. TNP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.
Time Frame
Baseline, Day 28 to focal neurological deficit (up to 1 year)
Title
Number of Participants With Objective Disease Response
Description
Objective disease response defined as participants with confirmed complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.
Time Frame
Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49
Title
Time to Objective Intracranial Progression
Description
Time in weeks from start of study treatment to first documentation of objective intracranial tumor progression. Intracranial tumor progression defined as ≥25% increase from smallest size in sum of products of all enhancing tumors or appearance of any new tumor, according to World Health Organization (WHO) criteria. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day added to each calculation. Time to Objective Intracranial Progression = (first event date minus the date of first dose of study medication plus 1) divided by 7.02.
Time Frame
Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year)
Title
Number of Participants With Intracranial Objective Disease Response
Description
Intracranial objective disease response defined as participants with confirmed CR or PR, according to WHO criteria. CR defined as disappearance of all enhancing tumor. PR defined as a ≥50% reduction from baseline in sum of the products of all enhancing tumors.
Time Frame
Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49
Title
Duration of Response (DR)
Description
DR defined as difference in weeks between first date criteria for progression occurred, or participant died due to any cause and first date that criteria for a PR or CR were met and subsequently confirmed ≥4 weeks later. Since day criteria for PR or CR were met and first day criteria for progression occurred (or participant died) were each counted as a full day, 1 day was added to each calculation. DR (in weeks) calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.
Time Frame
Day 7 of Week 4 and every 4 weeks up to 1 year
Title
Overall Survival (OS)
Description
OS calculated as: (date of death minus date of first dose plus 1)divided by 30.4.
Time Frame
Baseline until death (up to 1 year)
Title
Percentage of Participants Surviving at 1 Year
Description
Percentage of those surviving at end of 1 year from the first dose of study treatment.
Time Frame
Year 1
Title
Number of Deaths Due to Intracranial Versus Systemic Progression
Description
Number of deaths determined to be intracranial versus systemic progression, according to investigators'assessment.
Time Frame
Baseline until death (up to 1 year)
Title
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score
Description
Change from baseline in FLSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 24. Higher scores indicated better outcomes.
Time Frame
Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)
Title
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score
Description
Change from baseline in FBrSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 60. Higher scores indicated better outcomes.
Time Frame
Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)
Title
Trough Plasma Concentrations (Ctrough) of Sunitinib
Description
A single blood sample (4 milliliters [mL]) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.
Time Frame
Day 1 of Week 5, 9, and 13
Title
Ctrough of Sunitinib Metabolite (SU012662)
Description
A single blood sample (4 mL) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.
Time Frame
Day 1 of Week 5, 9, and 13
Title
Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts
Description
A blood sample (6mL) collected before treatment with Sunitinib and used to isolate deoxyribonucleic acid (DNA). These samples were not anonymized.
Time Frame
Day 1 prior to dosing
Title
Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile
Description
Tumor samples were not anonymized. RNA expression profile was to include colony-stimulating factor 1 receptor (CSF-1R), platelet-derived growth factor receptor alpha and beta (PDGFRalpha and PDGFRbeta), vascular endothelial growth factor (VEGF), VEGF-C, VEGF receptor 1, 2, and 3 (VEGFR1, VEGFR2, and VEGFR3), fibroblast growth factor (FGF), FMS-like tyrosine kinase 3 (FLT3), KIT (stem cell factor receptor), and RET (rearranged during transfection).
Time Frame
Day 1 of Week 1 and every 4 weeks up to 1 year
Title
PFS in Subgroups Defined by RNA Expression Profiles of Tumors
Description
PFS defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was to be determined in subgroups defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT3, KIT, and RET) level (low/high relative to expression of Glyceraldehyde-3-Phosphate Dehydrogenase [GAPDH] reference gene). PFS calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.
Time Frame
Day 1 of Week 1 and every 4 weeks up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with radiologically proven brain metastases secondary to non-small cell lung cancer
Received previous whole brain radiation therapy and none, 1 or 2 prior systemic therapy for the treatment of advanced/metastatic non-small cell lung cancer
Exclusion Criteria:
Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or leptomeningeal disease.
Brain metastases >4 cm in any linear direction
Intracranial or intratumoral hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Pfizer Investigational Site
City
Cocoa Beach
State/Province
Florida
ZIP/Postal Code
32931
Country
United States
Facility Name
Pfizer Investigational Site
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Facility Name
Pfizer Investigational Site
City
Titusville
State/Province
Florida
ZIP/Postal Code
32796
Country
United States
Facility Name
Pfizer Investigational Site
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-1094
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Pfizer Investigational Site
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Pfizer Investigational Site
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Pfizer Investigational Site
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Pfizer Investigational Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78664
Country
United States
Facility Name
Pfizer Investigational Site
City
Pessac
State/Province
Be1 04495
ZIP/Postal Code
33604
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille Cedex 09
ZIP/Postal Code
13009
Country
France
Facility Name
Pfizer Investigational Site
City
Saint-Priest en Jarez Cedex
ZIP/Postal Code
42271
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Orbassano (TO)
ZIP/Postal Code
10043
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00151
Country
Italy
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181092&StudyName=Study%20Tests%20The%20Safety%20And%20Effectiveness%20Of%20SU011248%20In%20Patients%20With%20Non-Small%20Cell%20Lung%20Cancer%20Having%20Brain%20Metastases
Description
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Learn more about this trial
Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases
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