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
Stopped early · Phase 1/Phase 2
Conditions studied: Locally Advanced or Metastatic Non Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT01526928
- Run by
- Clovis Oncology, Inc.
- People needed
- 612
- Starts
- 2012-03-27
- Expected to finish
- 2018-08-27
- Last updated by the study team
- 2020-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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 D.C., 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
Full record on ClinicalTrials.gov
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