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Rociletinib (CO-1686) USA Expanded Access Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02547675
Expanded Access Status : No longer available
First Posted : September 11, 2015
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
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+).

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Drug: Rociletinib

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.

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Study Type : Expanded Access
Official Title: 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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Rociletinib
    Rociletinib will be administered to patients orally
    Other Name: CO-1686

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547675


Locations
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United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85024
United States, California
Compassionate Care Research Group, Inc.
Fountain Valley, California, United States, 92866
Pacific Cancer Care
Monterey, California, United States, 93940
Sutter Cancer Institute
Sacramento, California, United States, 95816
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Florida
Halifax Health - Center for Oncology
Daytona Beach, Florida, United States, 32114
UF Health Center Orlando
Orlando, Florida, United States, 32806
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, Oklahoma
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
Sponsors and Collaborators
Clovis Oncology, Inc.
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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02547675    
Other Study ID Numbers: CO-1686-031
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms