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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
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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