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Spots Global Cancer Trial Database for Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients

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Trial Identification

Brief Title: Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients

Official Title: A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral Rociletinib in Patients With Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

Study ID: NCT01526928

Study Description

Brief Summary: Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.

Detailed Description: Lung cancer remains the most common cancer worldwide with non-small cell lung cancer accounting for 85% of cases. Cytotoxic chemotherapy has been the mainstay of patients with NSCLC; however, survival rates remain low and toxicity is significant. Molecularly targeted therapies have proven to be superior to chemotherapy for NSCLC patients whose tumors have mutations in EGFR. Recent studies have established tyrosine kinase inhibitors (TKIs) as the gold standard for treating EGFR-mutation-positive NCSLC. However, patients on TKIs eventually progress, and in approximately 50% of cases, progression is due to development of an additional mutation called T790M. There are currently no approved therapies for patients who progress on TKIs. Rociletinib may provide an effective therapy for a patient population with few alternative treatment options. Nonclinical data demonstrate that rociletinib inhibits T790M. It is anticipated that rociletinib may promote cell death in tumor cells with the T790M mutation, thus providing possible therapeutic benefit in patients who have developed T790M-mediated resistance to first generation TKIs. This is a two-part, open-label study of oral rociletinib administered daily in previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as erlotinib, gefitinib or afatinib. This study will include 2 parts: Phase 1: Dose-escalation Period with 21-day cycles; optional Treatment Extension Period starting on Day 22 Phase 2: Evaluation of activity and safety in patients with the T790M EGFR mutation who have: Cohort A - Progressed on EGFR directed therapy (irrespective of the number and order of previous lines of NSCLC therapy) or Cohort B - Progression on the first single agent EGFR directed therapy received and also had no more than one previous line of chemotherapy or Cohort C - Patients with discordance between local (T790M positive) and central (T790M negative) T790M results, or had no central test result due to inadequacy of the tissue specimen and known to be T790M positive by local test

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

City of Hope National Medical Center, Duarte, California, United States

Compassionate Care Research Group, Inc., Fountain Valley, California, United States

University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, California, United States

Samuel Oschin Cancer Center, Los Angeles, California, United States

University of California, Irvine, Orange, California, United States

University of California Davis Medical Center, Sacramento, California, United States

UCLA Health System, Santa Monica, California, United States

Stanford Cancer Institute, Stanford, California, United States

East Valley Hematology and Oncology Medical Group, Inc., Whittier, California, United States

The Oncology Institute of Hope and Innovations, Whittier, California, United States

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Georgetown University Hospital, Washington, District of Columbia, United States

Sylvester Comprehensive Cancer Center/UMHC, Miami, Florida, United States

Florida Hospital Cancer Institute, Orlando, Florida, United States

University Cancer & Blood Center, Athens, Georgia, United States

University of Chicago Medical Center, The Duchossois Center for Advanced Medicine, Chicago, Illinois, United States

University of Maryland, Baltimore, Maryland, United States

Mass General Hospital, Boston, Massachusetts, United States

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States

Karmanos Cancer Care Institute, Detroit, Michigan, United States

Regional Cancer Care Associates, Morristown, New Jersey, United States

Regional Cancer Center, New Brunswick, New Jersey, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Monter Cancer Center, Lake Success, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

University of Cincinnati Medical Center, Cincinnati, Ohio, United States

Ohio State University, Comprehensive Cancer Center, Columbus, Ohio, United States

Tulsa Cancer Institute, Tulsa, Oklahoma, United States

Providence CancerCenter Oncology and Hematology Care Clinic-Eastside Portland, Portland, Oregon, United States

Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPMC), Div. of Medical Oncology, Pittsburgh, Pennsylvania, United States

Vanderbilt University, Nashville, Tennessee, United States

University of Texas Southwestern Medical Center, Dallas, Texas, United States

MD Anderson Cancer Center, Houston, Texas, United States

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Virginia Cancer Specialists, PC, Fairfax, Virginia, United States

Swedish Cancer Institute, Seattle, Washington, United States

University of Washington, Seattle, Washington, United States

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

Peter MacCallum Cancer Centre, East Melbourne, , Australia

Centre Antoine Lacassagne, Nice Cedex 2, Provence Alpes COTE D'azur, France

Centre Hospitalier Universitaire de Grenoble, Grenoble Cedex 9, Rhone-alpes, France

Centre Léon Bérard, Lyon Cedex 04, Rhone-alpes, France

Centre François Baclesse, Caen Cedex 05, , France

Centre Hospitalier Intercommunal Créteil, Creteil cedex, , France

Centre Hospitalier Régional Universitaire de Lille, Lille, , France

Institut Gustave Roussy, Villejuif, , France

Med University Gdansk, Gdansk, , Poland

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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