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Trial record 1 of 1 for:    NCT00372775
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Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases

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ClinicalTrials.gov Identifier: NCT00372775
Recruitment Status : Completed
First Posted : September 7, 2006
Results First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 5, 2006
First Posted Date  ICMJE September 7, 2006
Results First Submitted Date  ICMJE December 8, 2010
Results First Posted Date  ICMJE February 24, 2011
Last Update Posted Date February 24, 2011
Study Start Date  ICMJE March 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
Progression-Free Survival (PFS) [ Time Frame: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year) ]
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]).
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
Progression free survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
  • Time to Tumor Progression (TTP) [ Time Frame: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year) ]
    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 Frame: Baseline, Day 28 to focal neurological deficit (up to 1 year) ]
    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 [ Time Frame: Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49 ]
    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 Frame: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year) ]
    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 [ Time Frame: Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49 ]
    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) [ Time Frame: Day 7 of Week 4 and every 4 weeks up to 1 year ]
    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) [ Time Frame: Baseline until death (up to 1 year) ]
    OS calculated as: (date of death minus date of first dose plus 1)divided by 30.4.
  • Percentage of Participants Surviving at 1 Year [ Time Frame: Year 1 ]
    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 [ Time Frame: Baseline until death (up to 1 year) ]
    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 [ Time Frame: Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year) ]
    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 [ Time Frame: Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year) ]
    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 [ Time Frame: Day 1 of Week 5, 9, and 13 ]
    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) [ Time Frame: Day 1 of Week 5, 9, and 13 ]
    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 [ Time Frame: Day 1 prior to dosing ]
    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 [ Time Frame: Day 1 of Week 1 and every 4 weeks up to 1 year ]
    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 [ Time Frame: Day 1 of Week 1 and every 4 weeks up to 1 year ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
Objective response rate and other measures of duration of tumor control (overall and intracranially), survival, safety and tolerability, patient reported outcomes and biomarkers.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases
Official Title  ICMJE A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases
Brief Summary This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: Sunitinib
Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity
Other Name: Sutent
Study Arms  ICMJE Experimental: Sunitinib
Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2010)
66
Original Enrollment  ICMJE
 (submitted: September 5, 2006)
60
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372775
Other Study ID Numbers  ICMJE A6181092
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP