Rociletinib (CO-1686) USA Expanded Access Program

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02547675
• Other study ID #: CO-1686-031
• Status: No longer available

Study information

• Verified date: September 2018
• Source: Clovis Oncology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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+).

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Rociletinib
Rociletinib will be administered to patients orally

Locations

Country	Name	City	State
United States	Billings Clinic	Billings	Montana
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Halifax Health - Center for Oncology	Daytona Beach	Florida
United States	Henry Ford Hospital	Detroit	Michigan
United States	Compassionate Care Research Group, Inc.	Fountain Valley	California
United States	Pacific Cancer Care	Monterey	California
United States	UF Health Center Orlando	Orlando	Florida
United States	Sutter Cancer Institute	Sacramento	California
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Tulsa Cancer Institute	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Clovis Oncology, Inc.

Country where clinical trial is conducted

United States,