Rociletinib (CO-1686) USA Expanded Access Program

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+).

Study Overview

• Status: No longer available
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: 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.

• Study Type: Expanded Access

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85024
      • Mayo Clinic Arizona
  • California
    • Fountain Valley, California, United States, 92866
      • Compassionate Care Research Group, Inc.
    • Monterey, California, United States, 93940
      • Pacific Cancer Care
    • Sacramento, California, United States, 95816
      • Sutter Cancer Institute
    • San Francisco, California, United States, 94115
      • UCSF Helen Diller Family Comprehensive Cancer Center
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Halifax Health - Center for Oncology
    • Orlando, Florida, United States, 32806
      • UF Health Center Orlando
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Tulsa Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Clovis Oncology, Inc.

Study record dates

Study Registration Dates

• First Submitted: September 10, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CO-1686-031