Clinical trial NCT02547675: Rociletinib (CO-1686) USA Expanded Access Program
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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Clovis Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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+).

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Fountain Valley
country: United States
facility: Compassionate Care Research Group, Inc.
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Institute
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Daytona Beach
country: United States
facility: Halifax Health - Center for Oncology
state: Florida
city: Orlando
country: United States
facility: UF Health Center Orlando
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Tulsa
country: United States
facility: Tulsa Cancer Institute
state: Oklahoma
Study officials:
References: