A Study of Rociletinib (CO-1686) for Patients with a Mutant form of Non-Small Cell Lung Cancer.

Overview

About this study

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+).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

 

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 
    • Substance abuse
    • Uncontrolled intercurrent illness including active infection
    • Arterial thrombosis
    • Symptomatic pulmonary embolism
    • Other active malignancy associated with life expectancy of less than 1 year
  • Pregnant or breastfeeding females 
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Helen Ross, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
.

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