Rociletinib (CO-1686) USA Expanded Access Program
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT02547675
- Lead Sponsor
- Clovis Oncology, Inc.
- 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+).
- Detailed Description
This is an open-label, multi-center study in the US, which allows for expanded access to rociletinib for patients with advanced or metastatic, EGFR-mutant T790M+ NSCLC who were previously treated with at least one prior EGFR TKI therapy (≥2nd line). Patients will receive oral rociletinib twice daily on study as long as they have clinical benefit and until they have access to FDA-approved rociletinib.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
Key
-
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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Billings Clinic
🇺🇸Billings, Montana, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Sutter Cancer Institute
🇺🇸Sacramento, California, United States
Pacific Cancer Care
🇺🇸Monterey, California, United States
Compassionate Care Research Group, Inc.
🇺🇸Fountain Valley, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Halifax Health - Center for Oncology
🇺🇸Daytona Beach, Florida, United States
UF Health Center Orlando
🇺🇸Orlando, Florida, United States
Tulsa Cancer Institute
🇺🇸Tulsa, Oklahoma, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States