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Brief Title: A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Paclitaxel in Combination With Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple- Negative Breast Cancer (FRIDA)
Study ID: NCT02370238
Brief Summary: The Objectives of this study: The primary objective of the study was to evaluate progression-free survival (PFS) (defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, as assessed by Independent Radiology Review, or death for any cause, whichever occured first) in patients with metastatic triple-negative breast cancer (TNBC) treated with the combination of paclitaxel and orally administered reparixin compared to paclitaxel alone. The secondary objectives were: * To determine overall survival (OS). * To evaluate objective response rates (ORR). * To determine median PFS (mPFS). * To assess the safety of the combination of paclitaxel and orally administered reparixin (referred to as combination treatment).
Detailed Description: The study is a two arm, phase 2 study to evaluate the efficacy of the combination of paclitaxel and reparixin compared to paclitaxel and placebo in metastatic TNBC patients. In the study two groups There were two groups: Group 1: paclitaxel 80 mg/m2 intravenous (i.v.) (Days 1, 8, and 15 of 28-day cycle) + reparixin oral tablets 1200 mg three times a day (t.i.d.) continuing from Day 1 to Day 21. Group 2: paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15 of 28-day cycle) + placebo oral tablets 1200 mg t.i.d. continuing from Day 1 to Day 21. Study drug (reparixin/placebo) was administered with water prior to the start of the i.v. paclitaxel infusion on Cycle 1, Day 1 and then administered approximately every eight hours (six to ten hours) for 21 consecutive days during each cycle with seven days off-treatment between each cycle. It was preferable that reparixin was taken with food. However, if the patient was unable to eat, study drug was allowed to be administered. When in combination with paclitaxel (Day 1, 8 and 15 of each cycle), reparixin or placebo was administered every approximately eight hours with about 250 mL water and a light meal or snack. Paclitaxel was administered in combination with study drug (reparixin/placebo) as an i.v. infusion on Days 1, 8 and 15 of each 28-day cycle. On Cycle 1, Day 1, paclitaxel was administered at the clinic after the administration of study drug (reparixin/placebo). From that point forward, study drug (reparixin/placebo) was self-administered t.i.d. for 21 days. Combination treatment (three weeks on and one week off) continued until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first. The next clinic visits were on Days 8 and 15 when a paclitaxel infusion was administered to the patient. The patients returned to the clinic again on Day 29/Day 1 of the next cycle. Tumor response and/or progression assessments were performed and documented every eight weeks according to RECIST criteria version 1.1. Metastatic tissue samples were analyzed for evaluation of CD24-CD44+ and aldehyde dehydrogenase positive (ALDH+) CSCs.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Southern Cancer Center, Mobile, Alabama, United States
CBCC Global Research a Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Florida Cancer Specialists, Daytona Beach, Florida, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
Atlanta Cancer Care, Alpharetta, Georgia, United States
Northside Hospital, Inc.-Georgia Cancer Specialists, Athens, Georgia, United States
Atlanta Cancer Care, Atlanta, Georgia, United States
Northside Hospital, Inc., Atlanta, Georgia, United States
Northside Hospital, Inc.-Georgia Cancer Specialists, Canton, Georgia, United States
Atlanta Cancer Care, Conyers, Georgia, United States
Atlanta Cancer Care, Cumming, Georgia, United States
Atlanta Cancer Care, Decatur, Georgia, United States
Northside Hospital, Inc.-Georgia Cancer Specialists, Decatur, Georgia, United States
Atlanta Cancer Care, Jonesboro, Georgia, United States
Northside Hospital, Inc.-Georgia Cancer Specialists, Macon, Georgia, United States
Northside Hospital, Inc.-Georgia Cancer Specialists, Marietta, Georgia, United States
Southeastern Regional Medical Center, Newnan, Georgia, United States
Northside Hospital, Inc.-Georgia Cancer Specialists, Sandy Springs, Georgia, United States
Swedish Covenant, Chicago, Illinois, United States
Mid Illinois Hematology & Oncology Associates, Ltd., Normal, Illinois, United States
University of Michigan Cancer Center, Ann Arbor, Michigan, United States
Summit Medical Group, Morristown, New Jersey, United States
Regional Cancer Care Associates, Sparta, New Jersey, United States
Waverly Hematology Oncology, Cary, North Carolina, United States
Hematology and Oncology Associates of Northeast PA, Dunmore, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Tennessee Oncology PLLC, Chattanooga, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
The Methodist Hospital, Houston, Texas, United States
Overlake Medical Center, Bellevue, Washington, United States
Fox Valley Hematology and Oncology, SC, Appleton, Wisconsin, United States
Algemeen Ziekenhuis Klina, Brasschaat, , Belgium
Cliniques Universitaires Saint- LUC UCL, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
CHU Ambroise Paré, Mons, , Belgium
AZ St Elisabeth, Namur, , Belgium
Masaryk Memorial Cancer Institute, Brno, , Czechia
Nemocnice Horovice a.s., Horovice, , Czechia
Fakultni nemocnice Hradec Králové, Hradec Králové, , Czechia
Onkologická klinika VFN a 1.LF UK, Prague 2, , Czechia
Fakultní nemocnice Královské Vinohrady, Praha 10, , Czechia
Fakultní nemocnice v Motole, Onkologická klinika 2. LF UK a FN Motol, Praha 5, , Czechia
Krajská nemocnice T.Bati, a. s., Zlin, , Czechia
Centre Paul Papin, Angers, , France
Centre François Baclesse, Caen, , France
Centre hospitalier de Saint-Brieuc, Yves Le Foll, La Roche sur Yon Cedex 9, , France
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren, Limoges, , France
Institut Paoli Calmettes, Marseille cedex 9, , France
Centre Antoine Lacassagne, Nice Cedex 2, , France
Hôpital Européen Georges Pompidou, Paris Cedex 15, , France
Medicale Centre René Gauducheau, Saint Herblain cedex, , France
Ospedale "Di Summa-Perrino", Brindisi, , Italy
Azienda Ospedaliero-Universitaria, Cagliari, , Italy
Azienda Ospedaliero - Universitaria, Policlinico Vittorio Emanuele, Catania, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Ospedale dell'Angelo, Mestre, , Italy
Istituto Europeo di Oncologia, Milan, , Italy
Azienda Ospedaliera, Ospedale San Carlo Borromeo, Milan, , Italy
Fondazione IRCCS Policlinico S. Matteo, Pavia, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, , Italy
Nuovo Ospedale, Prato, , Italy
Azienda Opspedaliero Universitaria Santa Maria della Misericordia, Udine, , Italy
Ospedale SS Giovanni e Paolo, Venezia, , Italy
Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie, Bialystok, , Poland
Wojewódzkie Centrum Onkologii, Gdansk, , Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli, Lublin, , Poland
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu, Poznan, , Poland
Mrukmed. Lekarz Beata Madej Mruk i Partner. Spólka Partnerska Oddzial nr 1 w Rzeszowie, Rzeszów, , Poland
Magodent Sp. z o. o., Warsaw, , Poland
Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica, La Coruña, Galizia, Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Complejo Hospitalario Universitario La Coruña, La Coruña, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro, Madrid, , Spain
C. Hospital Xeral-Cies, Vigo, , Spain
Name: Lori J Goldstein, MD
Affiliation: FASCOFox Chase Cancer Center
Role: PRINCIPAL_INVESTIGATOR