Rociletinib (CO-1686) USA Expanded Access Program
An Expanded Access Protocol of Oral Rociletinib (CO-1686) as Epidermal Growth Factor Receptor (EGFR)-Directed Therapy for Patients With EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) With the T790M Resistance Mutation
1 other identifier
expanded_access
N/A
1 country
11
Brief Summary
To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC who have been treated previously with EGFR directed therapy and have evidence of a T790M mutation (T790M+).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedSeptember 25, 2018
September 1, 2018
September 10, 2015
September 24, 2018
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Unresectable locally advanced or metastatic NSCLC with EGFR activating mutation (excluding exon 20 insertion) and presence of the T790M mutation
- Prior treatment with an approved or experimental EGFR-directed therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate hematological and biological function
- Written informed consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF before any study-specific evaluation
You may not qualify if:
- Eligibility for other enrolling clinical trials of rociletinib
- Leptomeningeal carcinomatosis or other untreated or symptomatic CNS metastases (asymptomatic CNS metastases allowed if clinically stable without requirement for steroid dose increase for at least 4 weeks)
- History of prior interstitial lung disease
- Concurrent use of QT-prolonging medication
- Cardiac abnormalities:
- Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) \> 450 ms
- Inability to measure QT interval on ECG
- Personal or family history of long QT syndrome
- Implantable pacemaker or implantable cardioverter defibrillator
- Resting bradycardia \< 55 beats/min
- Presence of serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism, and other active malignancy associated with life expectancy of less than 1 year)
- Pregnant or breastfeeding females and male or female patients who refuse to use adequate contraception during the study and for 12 weeks after the last dose of rociletinib
- Any contraindication, allergy, or hypersensitivity to rociletinib or excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Mayo Clinic Arizona
Scottsdale, Arizona, 85024, United States
Compassionate Care Research Group, Inc.
Fountain Valley, California, 92866, United States
Pacific Cancer Care
Monterey, California, 93940, United States
Sutter Cancer Institute
Sacramento, California, 95816, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
Halifax Health - Center for Oncology
Daytona Beach, Florida, 32114, United States
UF Health Center Orlando
Orlando, Florida, 32806, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Billings Clinic
Billings, Montana, 59101, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 11, 2015
Last Updated
September 25, 2018
Record last verified: 2018-09