Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases

NCT00372775 | Completed Phase 2 Results

• 1 other identifier: A6181092
• Study Type: interventional
• Target: 66
• Locations: 4 countries
• Sites: 27

Brief Summary

This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.

Conditions

Non-Small Cell Lung Cancer

Keywords

brain metastases; Sunitinib; Phase 2

Outcome Measures

Primary Outcomes (1)

• 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 \[PD\]).

  Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)

Secondary Outcomes (16)

• Time to Tumor Progression (TTP)

  Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year)

• Time to Neurological Progression (TNP)

  Baseline, Day 28 to focal neurological deficit (up to 1 year)

• Number of Participants With Objective Disease Response

  Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49

• Time to Objective Intracranial Progression

  Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year)

• Number of Participants With Intracranial Objective Disease Response

  Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49

Study Arms (1)

Sunitinib

EXPERIMENTAL

Drug: Sunitinib

Interventions

Sunitinib DRUG

Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity

Also known as: Sutent

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or leptomeningeal disease.
• Brain metastases \>4 cm in any linear direction
• Intracranial or intratumoral hemorrhage

Sponsors & Collaborators

• Pfizer: lead

Study Sites (27)

Pfizer Investigational Site

Norwalk, Connecticut, 06856, United States

Location

Pfizer Investigational Site

Cocoa Beach, Florida, 32931, United States

Location

Pfizer Investigational Site

Merritt Island, Florida, 32952, United States

Location

Pfizer Investigational Site

Titusville, Florida, 32796, United States

Location

Pfizer Investigational Site

City of Saint Peters, Missouri, 63376, United States

Location

Pfizer Investigational Site

Creve Coeur, Missouri, 63141, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110-1094, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Basking Ridge, New Jersey, 07920, United States

Location

Pfizer Investigational Site

Commack, New York, 11725, United States

Location

Pfizer Investigational Site

New York, New York, 10022, United States

Location

Pfizer Investigational Site

Sayre, Pennsylvania, 18840, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Austin, Texas, 78745, United States

Location

Pfizer Investigational Site

Austin, Texas, 78758, United States

Location

Pfizer Investigational Site

Austin, Texas, 78759, United States

Location

Pfizer Investigational Site

Round Rock, Texas, 78664, United States

Location

Pfizer Investigational Site

Pessac, Be1 04495, 33604, France

Location

Pfizer Investigational Site

Saint-Priest-en-Jarez, France, 42271, France

Location

Pfizer Investigational Site

Marseille, 13009, France

Location

Pfizer Investigational Site

Toulouse, 31059, France

Location

Pfizer Investigational Site

Bologna, 40139, Italy

Location

Pfizer Investigational Site

Genova, 16132, Italy

Location

Pfizer Investigational Site

Orbassano (TO), 10043, Italy

Location

Pfizer Investigational Site

Roma, 00151, Italy

Location

Pfizer Investigational Site

Madrid, Madrid, 28046, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46014, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 7, 2006
• Study Start: March 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 24, 2011
• Results First Posted: February 24, 2011

Record last verified: 2011-01

Locations

ES (2); US (17); FR (4); IT (4)