Rociletinib (CO-1686) USA Expanded Access Program

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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+).

Details

• Lead Sponsor: Clovis Oncology, Inc.

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