Lung Cancer Clinical Trial

Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer

Summary

The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.

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Full Description

This is a Phase 2, single arm, open-label, dual cohort, multicenter study evaluating the safety and efficacy of rociletinib administered orally to patients with previously treated mutant EGFR NSCLC.

Patients will be enrolled into 2 cohorts. Cohort A will enroll approximately 125 eligible patients who are centrally confirmed T790M-positive. Cohort B will be a continuation of the study and will enroll up to approximately 100 eligible patients who will be either centrally confirmed T790M-positive or T790M-negative.

All patients (for Cohort A and B) should have experienced disease progression while on treatment with the first single-agent EGFR-directed TKI (EGFR-TKI) for advanced/metastatic NSCLC. One line of chemotherapy prior to the EGFR-TKI treatment is permissible.

The study (Cohorts A and B) will consist of a screening phase to establish study eligibility and document baseline measurements, an open-label treatment phase, in which the patient will receive rociletinib to ascertain safety and efficacy until disease progression as defined by RECIST Version 1.1, clinical tumor progression, or unacceptable toxicity as assessed by the investigator. For patients with clinical progression, radiographic assessment should be performed to document evidence of radiographic progression.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC
Documented evidence of a tumor with 1 or more EGFR mutations excluding exon 20 insertion
Disease progression confirmed by radiologic assessment while receiving treatment with the first single agent EGFR-TKI
EGFR TKI treatment discontinued less than or equal to 30 days prior to planned initiation of rociletinib
The washout period for an EGFR inhibitor is a minimum of 3 days
No intervening treatment between cessation of single agent EGFR TKI and planned initiation of rociletinib
Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent)
Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less
Central laboratory confirmation of the presence of the T790M mutation in tumor tissue in Cohort A and the presence or absence of the T790M mutation in tumor tissue in Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable. Biopsy material obtained from either primary or metastatic tumor tissue and sent to the central laboratory must be within 60 prior to dosing study drug but following disease progression on the first EGFR TKI
Measurable disease according to RECIST Version 1.1
Life expectancy of at least 3 months
ECOG performance status of 0 to 1
Minimum Age 18 years (in certain territories, the minimum age requirement may be higher eg age 20 years in Japan and Taiwan)
Adequate hematological and biological function, confirmed by defined laboratory values
Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study specific evaluation

Exclusion Criteria

Documented evidence of an exon 20 insertion activating mutation in the EGFR gene
Active second malignancy i.e. patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment
Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enrol in the trial provided all chemotherapy was completed greater than 6 months prior and/or bone marrow transplant greater than 2 years prior
Known pre-existing interstitial lung disease
Cohort A only: Patients with leptomeningeal carcinomatosis are excluded. Other central nervous system (CNS) metastases are only permitted if treated, asymptomatic, and stable (not requiring steroid for at least 4 weeks prior to the start of study treatment). Cohort B only: Patients with CNS metastases or leptomeningeal carcinomatosis are excluded.
Treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib
Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib
Prior treatment with rociletinib, or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR
Any of the following cardiac abnormalities or history
Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) greater than 450 msec
Inability to measure QT interval on ECG
Personal or family history of long QT syndrome
Implantable pacemaker or implantable cardioverter defibrillator
Resting bradycardia less than 55 beats/min
Non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib. In all cases, the patient must be sufficiently recovered and stable before treatment administration
Females who are pregnant or breastfeeding
Refusal to use adequate contraception for fertile patients (females and males) while on treatment and for 12 weeks after the last dose of rociletinib
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Any other reason the investigator considers the patient should not participate in the study

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

318

Study ID:

NCT02147990

Recruitment Status:

Terminated

Sponsor:

Clovis Oncology, Inc.

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There are 78 Locations for this study

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UCLA Medical Center
Alhambra California, 91801, United States
Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
Saint Jude Heritage Healthcare
Fullerton California, 92835, United States
University of California San Diego Moores Cancer Center
La Jolla California, 92093, United States
Northridge Hospital Medical Center
Northridge California, 91328, United States
Cancer Care Associates
Redondo Beach California, 90277, United States
University of California Davis Medical Center
Sacramento California, 95817, United States
University of California San Francisco
San Francisco California, 94115, United States
Coastal Integrative Cancer Care
San Luis Obispo California, 93401, United States
Saint Mary's Regional Cancer Center
Grand Junction Colorado, 81501, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree Colorado, 80218, United States
Yale University School of Medicine
New Haven Connecticut, 32135, United States
Advanced Medical Specialties
Miami Florida, 33176, United States
Cleveland Clinic Florida
Weston Florida, 33331, United States
Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States
University of Illinois Chicago
Chicago Illinois, 60612, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Beth Israel Comprehensive Cancer Center
Boston Massachusetts, 02215, United States
Lahey Hospital and Medical Center
Burlington Massachusetts, 01805, United States
Minnesota Oncology Hematology, P.A
Minneapolis Minnesota, 55404, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Montefiore Medical Center
Bronx New York, 10461, United States
New York Oncology Hematology, PC
Latham New York, 12110, United States
University of Rochester
Rochester New York, 14642, United States
University Hospitals of Cleveland
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Texas Oncology P.A.
Amarillo Texas, 79106, United States
USO - Texas Oncology P.A.
Arlington Texas, 76014, United States
Texas Oncology-Austin Central
Austin Texas, 78705, United States
Texas Oncology-Beaumont
Beaumont Texas, 77702, United States
Texas Oncology P.A.
Bedford Texas, 76022, United States
Texas Oncology P.A.
Dallas Texas, 75246, United States
Texas Oncology P.A.
Flower Mound Texas, 75028, United States
The Methodist Hospital
Houston Texas, 77030, United States
Texas Oncology - Plano East
Plano Texas, 75075, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Northwest Cancer Specialists, P.C.
Vancouver Washington, 98686, United States
Yakima Valley Memorial Hospital, North Star Lodge
Yakima Washington, 98902, United States
Icon Cancer Centre
South Brisbane New South Wales, 4101, Australia
Royal North Shore Hospital
Sydney New South Wales, 2065, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Centre Hospitalier Regional Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz
Besançon Franche-comte, 25030, France
Hôpital Tenon
Paris Ile-de-france, 75020, France
Institut Gustave Roussy
Villejuif Ile-de-France, 94805, France
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint Herblain cedex PAYS DE LA Loire, , France
Centre Hospitalier Lyon Sud
Pierre Bénité cedex Rhone-alpes, 69495, France
Centre Hospitalier Universitaire Côte de Nacre
Caen , , France
Centre Hospitalier Universitaire Hôpital Nord
Marseille Cedex 20 , 13915, France
Asklepios Fachkliniken München-Gauting
Gauting Bayern, 82131, Germany
Klinikum Innenstadt LMU
München Bayern, 80336, Germany
Goethe-Universität Frankfurt am Main
Frankfurt am Main Hessen, 60590, Germany
Pius Hospital Oldenburg
Oldenburg Niedersachsen, 26121, Germany
Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III
Bonn Nordrhein-westfalen, 53127, Germany
Universitätsklinikum Essen
Essen Nordrhein-westfalen, 45122, Germany
Universitätsklinikum Köln
Köln Nordrhein-westfalen, 50937, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf Schleswig-holstein, 22927, Germany
Evangelische Lungenklinik Berlin
Berlin , 13125, Germany
Queen Mary Hospital
Hong Kong , , Hong Kong
Chungbuk National University Hospital
Chungju Chungcheongbuk-do, , Korea, Republic of
National Cancer Center
Goyang-si Gyeonggi-do, , Korea, Republic of
Gachon University Gil Medical Center
Incheon Gyeonggi-do, 405-7, Korea, Republic of
Dong-A University Hospital
Busan , , Korea, Republic of
Inha University Hospital
Incheon , 400-7, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Asan Medical Center
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
Seoul Saint Mary's Hospital
Seoul , , Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , , Korea, Republic of
Antoni van Leeuwenhoek Hospital
Amsterdam Noord-holland, 1066 , Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam , 1081 , Netherlands
Hospital Universitario Virgen del Rocio
Seville Sevilla, 41013, Spain
Hospital Universitari Germans Trias i Pujol
Badalona , , Spain
Hospital Vall d´Hebrón
Barcelona , 08035, Spain
Hospital Universitario Quirón Dexeus
Barcelona , , Spain
Hospital Universitario La Paz
Madrid , , Spain
Centre Hospitalier Universitaire Vaudoise
Lausanne Vaud, 1011, Switzerland
Taipei Veterans General Hospital
Taipei Taipei CITY, 11217, Taiwan
Chang Gung Memorial Hospital Linkou
Taoyuan Tao-Yuan, 33305, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Cambridge University Hospitals NHS Foundation Trust
Cambridge England, CB2 0, United Kingdom
Guy's and Saint Thomas NHS Foundation Trust
London Greater London, SE1 9, United Kingdom
Royal Marsden Hospital
London Greater London, SW3 6, United Kingdom
Royal Marsden NHS Trust
Sutton Surrey, SM2 5, United Kingdom
University College Hospital
London , NW1 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

318

Study ID:

NCT02147990

Recruitment Status:

Terminated

Sponsor:


Clovis Oncology, Inc.

How clear is this clinincal trial information?

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