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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

612

Participants

Timeline

Start Date

March 27, 2012

Primary Completion Date

July 3, 2018

Study Completion Date

August 27, 2018

Conditions
Locally Advanced or Metastatic Non Small Cell Lung Cancer
Interventions
DRUG

Rociletinib

Phase 1: Rociletinib \<900 mg BID FB will be administered in escalating dosages in a period of 21-day cycles

DRUG

Rociletinib

Phase 1: Rociletinib 900 mg BID FB will be administered in escalating dosages in a period of 21-day cycles

DRUG

Rociletinib

"Phase 1: Rociletinib 500 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles~Phase 2: Rociletinib 500 mg BID HBr will be administered daily"

DRUG

Rociletinib

"Phase 1: Rociletinib 625 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles~Phase 2: Rociletinib 625 mg BID HBr will be administered daily"

DRUG

Rociletinib

"Phase 1: Rociletinib 750 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles~Phase 2: Rociletinib 750 mg BID HBr will be administered daily"

DRUG

Rociletinib

"Phase 1: Rociletinib 1000 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles~Phase 2: Rociletinib 1000 mg BID HBr will be administered daily"

Trial Locations (49)

2050

Chris O'Brien Lifehouse, Camperdown

10065

Memorial Sloan Kettering Cancer Center, New York

11042

Monter Cancer Center, Lake Success

14263

Roswell Park Cancer Institute, Buffalo

15232

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

19104

Perelman Center for Advanced Medicine, Philadelphia

20007

Georgetown University Hospital, Washington D.C.

21201

University of Maryland, Baltimore

22031

Virginia Cancer Specialists, PC, Fairfax

30607

University Cancer & Blood Center, Athens

32804

Florida Hospital Cancer Institute, Orlando

33136

Sylvester Comprehensive Cancer Center/UMHC, Miami

37235

Vanderbilt University, Nashville

43202

Ohio State University, Comprehensive Cancer Center, Columbus

45219

University of Cincinnati Medical Center, Cincinnati

48201

Karmanos Cancer Care Institute, Detroit

60637

University of Chicago Medical Center, The Duchossois Center for Advanced Medicine, Chicago

74146

Tulsa Cancer Institute, Tulsa

77030

MD Anderson Cancer Center, Houston

80045

University of Colorado Anschutz Medical Campus, Aurora

84112

Huntsman Cancer Institute, Salt Lake City

90033

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

90048

Samuel Oschin Cancer Center, Los Angeles

90404

UCLA Health System, Santa Monica

90603

East Valley Hematology and Oncology Medical Group, Inc., Whittier

The Oncology Institute of Hope and Innovations, Whittier

91010

City of Hope National Medical Center, Duarte

92708

Compassionate Care Research Group, Inc., Fountain Valley

92868

University of California, Irvine, Orange

94305

Stanford Cancer Institute, Stanford

94805

Institut Gustave Roussy, Villejuif

95817

University of California Davis Medical Center, Sacramento

97213

Providence CancerCenter Oncology and Hematology Care Clinic-Eastside Portland, Portland

98104

Swedish Cancer Institute, Seattle

98109

University of Washington, Seattle

02114

Mass General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

48106-0995

Saint Joseph Mercy Hospital, Ann Arbor

07962

Regional Cancer Care Associates, Morristown

07834

Regional Cancer Center, New Brunswick

75390-9179

University of Texas Southwestern Medical Center, Dallas

Unknown

Peter MacCallum Cancer Centre, East Melbourne

Centre Hospitalier Universitaire de Grenoble, Grenoble

Centre Léon Bérard, Lyon

Centre François Baclesse, Caen

Centre Hospitalier Intercommunal Créteil, Créteil

Centre Hospitalier Régional Universitaire de Lille, Lille

Med University Gdansk, Gdansk

06189

Centre Antoine Lacassagne, Nice

Sponsors
All Listed Sponsors
lead

Clovis Oncology, Inc.

INDUSTRY

NCT01526928 - 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 | Biotech Hunter | Biotech Hunter