Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)
Sponsor: Alaunos Therapeutics
Summary
This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of palifosfamide-tris, carboplatin and etoposide (PaCE) chemotherapy in chemotherapy-naive subjects with extensive-stage small cell lung cancer (SCLC). Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or carboplatin and etoposide (CE) chemotherapy. The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. Secondary efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response and changes in quality of life (QOL) and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed. An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.
Official title: A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
188
Start Date
2012-06-08
Completion Date
2014-12-02
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
Carboplatin
AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.
Palifosfamide-tris
130 mg/m2/day 3 days every 21 days for a max of 6 cycles.
Etoposide
100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
Carboplatin
AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.
Locations (79)
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
Redwood Regional Oncology Group
Santa Rosa, California, United States
Christiana Care Health Services
Newark, Delaware, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Peachtree Hematology Oncology Consultants
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Medical and Surgical Specialists, LLC
Galesburg, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Central Indiana Cancer Centers
Fishers, Indiana, United States
Goshen Center for Cancer Care
Goshen, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
Horizon Oncology Center
Lafayette, Indiana, United States
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, United States
University of Kansas Hospital
Overland Park, Kansas, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Medical Oncology, LLC
Baton Rouge, Louisiana, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States
Metro Health Cancer Center
Wyoming, Michigan, United States
Saint Mary's Medical Center
Duluth, Minnesota, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center
Morristown, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
New York Oncology Hematology, PC
Albany, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Dayton Cancer Center, Medical Oncology Hematology Associates
Dayton, Ohio, United States
Medical Oncology Associates Of Wyoming Valley, PC
Kingston, Pennsylvania, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States
Texas Oncology-Medical City Dallas
Dallas, Texas, United States
Texas Oncology- Baylor, Charles A. Sammons Cancer Center
Dallas, Texas, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Oncology Consultants, PA
Houston, Texas, United States
Texas Oncology, PA
Wichita Falls, Texas, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Fairfax Northern Virginia Hematology-Oncology, PC
Fairfax, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Wisconsin Institutes for Medical Research
Madison, Wisconsin, United States
Southern Medical Day Oncology Care Centre
Wollongong, New South Wales, Australia
CancerCare Manitoba
Winnipeg, Manitoba, Canada
R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Hôpital Laval
Sainte-Foy, Quebec, Canada
Centre Hospitalier Lyon Sud
Pierre Bénité, Auvergne-Rhône-Alpes, France
Centre François Baclesse
Caen, Basse-normandie, France
Centre Hospitalier Universitaire -Hôpital Morvan
Brest, Brittany Region, France
Centre Hospitalier Universitaire, Hopital Bretonneau
Tours, Centre-Val de Loire, France
Hôpital du Cluzeau
Limoges, Limousin, Lorraine, France
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, Pays de la Loire Region, France
Hôpital Saint Joseph
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Paul Strauss
Strasbourg, France
Debreceni Egyetem Orvos és Egészségtudományi Centrum
Debrecen, Hajdú-Bihar, Hungary
Mátrai Gyógyintézet
Mátraháza, Heves County, Hungary
Rambam Medical Center
Haifa, Israel
Hadassah Medical Organization, Ein Kerem
Jerusalem, Israel
Meir Hospital Sapir Medical Center
Kfar Saba, Israel
Western Gallilee Medical Center
Nahariya, Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, Israel
Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, Italy
Presidio Ospedaliero S. Chiara
Trento, Italy
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Wojewódzkie Centrum Onkologii
Gdansk, Pomeranian Voivodeship, Poland
Specjalistyczny Szpital im. Alfreda Sokolowskiego
Szczecin, West Pomeranian Voivodeship, Poland
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
Ufa, Bashkortostan Republic, Russia
City Oncology Hospital # 62
Moscow Region, Moscow, Russia
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, Primorskiy (Maritime) Kray, Russia
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
Kazan', Tatarstan Republic, Russia
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
Chelaybinsk, Russia
Ivanovo Regional Oncology Centre
Ivanovo, Russia
Cancer Research Center n.a. N.N. Blokhin
Moscow, Russia
GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary
Nizhny Novgorod, Russia
State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"
Saint Petersburg, Russia
Saint-Petersburg State Medical University n. a. I. P. Pavlov
Saint Petersburg, Russia
State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"
Yaroslavl, Russia
China Medical University Hospital
Taichung, Taiwan
Wythenshawe Hospital
Manchester, England, United Kingdom