Rociletinib (CO-1686) USA Expanded Access Program



Status:No longer available
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/27/2018

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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

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+).

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.

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
We found this trial at
11
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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San Francisco, CA
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Billings, MT
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Daytona Beach, Florida 32114
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Daytona Beach, FL
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Fountain Valley, California 92708
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Fountain Valley, CA
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Monterey, California 93940
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Monterey, CA
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Orlando, Florida 32806
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Orlando, FL
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Sacramento, California 95816
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Sacramento, CA
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Scottsdale, AZ
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12697 E 51st Street South
Tulsa, Oklahoma 74146
918-505-3200
Tulsa Cancer Institute, Pllc Now under the new name of Tulsa Cancer Institute, our specialists...
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Tulsa, OK
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