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Rociletinib (CO-1686) USA Expanded Access Program

Primary Purpose

Non-small Cell Lung Cancer

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Rociletinib
Sponsored by
Clovis Oncology, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Mayo Clinic Arizona
  • Compassionate Care Research Group, Inc.
  • Pacific Cancer Care
  • Sutter Cancer Institute
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Halifax Health - Center for Oncology
  • UF Health Center Orlando
  • Beth Israel Deaconess Medical Center
  • Henry Ford Hospital
  • Billings Clinic
  • Tulsa Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 10, 2015
Last Updated
September 24, 2018
Sponsor
Clovis Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02547675
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clovis Oncology, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rociletinib
Other Intervention Name(s)
CO-1686
Intervention Description
Rociletinib will be administered to patients orally

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85024
Country
United States
Facility Name
Compassionate Care Research Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92866
Country
United States
Facility Name
Pacific Cancer Care
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Sutter Cancer Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Halifax Health - Center for Oncology
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
UF Health Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Tulsa Cancer Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Rociletinib (CO-1686) USA Expanded Access Program

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