Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00372775
First received: September 5, 2006
Last updated: January 27, 2011
Last verified: January 2011
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Purpose
This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Sunitinib |
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 Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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) ] [ 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. 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 Frame: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 66 |
| Study Start Date: | March 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sunitinib |
Drug: Sunitinib
Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity
Other Name: Sutent
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372775
Locations
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Norwalk, Connecticut, United States, 06856 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Cocoa Beach, Florida, United States, 32931 | |
| Pfizer Investigational Site | |
| Merritt Island, Florida, United States, 32952 | |
| Pfizer Investigational Site | |
| Titusville, Florida, United States, 32796 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Creve Coeur, Missouri, United States, 63141 | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63110-1094 | |
| Pfizer Investigational Site | |
| St. Peters, Missouri, United States, 63376 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Basking Ridge, New Jersey, United States, 07920 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Commack, New York, United States, 11725 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10022 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Sayre, Pennsylvania, United States, 18840 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78705 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78745 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78758 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78759 | |
| Pfizer Investigational Site | |
| Round Rock, Texas, United States, 78664 | |
| France | |
| Pfizer Investigational Site | |
| Pessac, Be1 04495, France, 33604 | |
| Pfizer Investigational Site | |
| Marseille Cedex 09, France, 13009 | |
| Pfizer Investigational Site | |
| Saint-Priest en Jarez Cedex, France, 42271 | |
| Pfizer Investigational Site | |
| Toulouse cedex 9, France, 31059 | |
| Italy | |
| Pfizer Investigational Site | |
| Bologna, Italy, 40139 | |
| Pfizer Investigational Site | |
| Genova, Italy, 16132 | |
| Pfizer Investigational Site | |
| Orbassano (TO), Italy, 10043 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00151 | |
| Spain | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28046 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46014 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00372775 History of Changes |
| Other Study ID Numbers: | A6181092 |
| Study First Received: | September 5, 2006 |
| Results First Received: | December 8, 2010 |
| Last Updated: | January 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
brain metastases Sunitinib Phase 2 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Brain Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes |
Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System 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 16, 2013