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Rociletinib (CO-1686) USA Expanded Access Program

Sponsor
Clovis Oncology, Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT02547675
Collaborator
(none)
11
Locations

Study Details

Study Description

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 Phase

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.

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Scottsdale Arizona United States 85024
    2 Compassionate Care Research Group, Inc. Fountain Valley California United States 92866
    3 Pacific Cancer Care Monterey California United States 93940
    4 Sutter Cancer Institute Sacramento California United States 95816
    5 UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California United States 94115
    6 Halifax Health - Center for Oncology Daytona Beach Florida United States 32114
    7 UF Health Center Orlando Orlando Florida United States 32806
    8 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    9 Henry Ford Hospital Detroit Michigan United States 48202
    10 Billings Clinic Billings Montana United States 59101
    11 Tulsa Cancer Institute Tulsa Oklahoma United States 74146

    Sponsors and Collaborators

    • Clovis Oncology, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clovis Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT02547675
    Other Study ID Numbers:
    • CO-1686-031
    First Posted:
    Sep 11, 2015
    Last Update Posted:
    Sep 25, 2018
    Last Verified:
    Sep 1, 2018
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Sep 25, 2018