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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: Sunitinib (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

Official title: A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-Free Survival (PFS)

Secondary outcome:

Time to Tumor Progression (TTP)

Time to Neurological Progression (TNP)

Number of Participants With Objective Disease Response

Time to Objective Intracranial Progression

Number of Participants With Intracranial Objective Disease Response

Duration of Response (DR)

Overall Survival (OS)

Percentage of Participants Surviving at 1 Year

Number of Deaths Due to Intracranial Versus Systemic Progression

Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score

Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score

Trough Plasma Concentrations (Ctrough) of Sunitinib

Ctrough of Sunitinib Metabolite (SU012662)

Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts

Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile

PFS in Subgroups Defined by RNA Expression Profiles of Tumors

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, Marseille Cedex 09 13009, France

Pfizer Investigational Site, Saint-Priest en Jarez Cedex 42271, France

Pfizer Investigational Site, Toulouse cedex 9 31059, France

Pfizer Investigational Site, Bologna 40139, Italy

Pfizer Investigational Site, Genova 16132, Italy

Pfizer Investigational Site, Orbassano (TO) 10043, Italy

Pfizer Investigational Site, Roma 00151, Italy

Pfizer Investigational Site, Madrid 28046, Spain

Pfizer Investigational Site, Valencia 46014, Spain

Pfizer Investigational Site, Pessac, Be1 04495 33604, France

Pfizer Investigational Site, Norwalk, Connecticut 06856, United States

Pfizer Investigational Site, Cocoa Beach, Florida 32931, United States

Pfizer Investigational Site, Merritt Island, Florida 32952, United States

Pfizer Investigational Site, Titusville, Florida 32796, United States

Pfizer Investigational Site, Creve Coeur, Missouri 63141, United States

Pfizer Investigational Site, St. Louis, Missouri 63110-1094, United States

Pfizer Investigational Site, St. Louis, Missouri 63110, United States

Pfizer Investigational Site, St. Peters, Missouri 63376, United States

Pfizer Investigational Site, Basking Ridge, New Jersey 07920, United States

Pfizer Investigational Site, Commack, New York 11725, United States

Pfizer Investigational Site, New York, New York 10022, United States

Pfizer Investigational Site, Sayre, Pennsylvania 18840, United States

Pfizer Investigational Site, Austin, Texas 78758, United States

Pfizer Investigational Site, Austin, Texas 78745, United States

Pfizer Investigational Site, Austin, Texas 78759, United States

Pfizer Investigational Site, Austin, Texas 78705, United States

Pfizer Investigational Site, Round Rock, Texas 78664, United States

Additional Information

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

Starting date: March 2007
Last updated: January 27, 2011

Page last updated: August 23, 2015

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