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
Public ClinicalTrials.gov record NCT01526928. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01526928
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 612 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 27, 2012 (Actual)
- Primary completion
- Jul 3, 2018 (Actual)
- Completion
- Aug 27, 2018 (Actual)
- Last update posted
- Aug 4, 2020
2012 – 2018
United States locations
- U.S. sites
- 39
- U.S. states
- 20
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| Compassionate Care Research Group, Inc. | Fountain Valley | California | 92708 | — |
| University of Southern California, Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Samuel Oschin Cancer Center | Los Angeles | California | 90048 | — |
| University of California, Irvine | Orange | California | 92868 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| UCLA Health System | Santa Monica | California | 90404 | — |
| Stanford Cancer Institute | Stanford | California | 94305 | — |
| East Valley Hematology and Oncology Medical Group, Inc. | Whittier | California | 90603 | — |
| The Oncology Institute of Hope and Innovations | Whittier | California | 90603 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Sylvester Comprehensive Cancer Center/UMHC | Miami | Florida | 33136 | — |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | — |
| University Cancer & Blood Center | Athens | Georgia | 30607 | — |
| University of Chicago Medical Center, The Duchossois Center for Advanced Medicine | Chicago | Illinois | 60637 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Mass General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106-0995 | — |
| Karmanos Cancer Care Institute | Detroit | Michigan | 48201 | — |
| Regional Cancer Care Associates | Morristown | New Jersey | 07962 | — |
| Regional Cancer Center | New Brunswick | New Jersey | 07834 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Monter Cancer Center | Lake Success | New York | 11042 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | — |
| Ohio State University, Comprehensive Cancer Center | Columbus | Ohio | 43202 | — |
| Tulsa Cancer Institute | Tulsa | Oklahoma | 74146 | — |
| Providence CancerCenter Oncology and Hematology Care Clinic-Eastside Portland | Portland | Oregon | 97213 | — |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Cancer Institute (UPMC), Div. of Medical Oncology | Pittsburgh | Pennsylvania | 15232 | — |
| Vanderbilt University | Nashville | Tennessee | 37235 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9179 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| University of Washington | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01526928, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2020 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01526928 live on ClinicalTrials.gov.