Lung Cancer Clinical Trial

Rociletinib (CO-1686) USA Expanded Access Program

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+).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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 Exclusion Criteria:

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 is for people with:

Lung Cancer

Study ID:

NCT02547675

Recruitment Status:

No longer available

Sponsor:

Clovis Oncology, Inc.

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There are 11 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Study ID:

NCT02547675

Recruitment Status:

No longer available

Sponsor:


Clovis Oncology, Inc.

How clear is this clinincal trial information?

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