Rociletinib (CO-1686) USA Expanded Access Program
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+).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 25, 2018 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Expanded Access
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Expanded Access
- Phase
- Not applicable
- Sponsor
- Clovis Oncology, Inc.
- Interventions being studied
- Drug: Rociletinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic ArizonaScottsdale, Arizona
- Compassionate Care Research Group, Inc.Fountain Valley, California
- Pacific Cancer CareMonterey, California
- Sutter Cancer InstituteSacramento, California
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Halifax Health - Center for OncologyDaytona Beach, Florida
- UF Health Center OrlandoOrlando, Florida
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Henry Ford HospitalDetroit, Michigan
- Billings ClinicBillings, Montana
- Tulsa Cancer InstituteTulsa, Oklahoma
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 25, 2018. Always confirm current availability with the study team.