Spots Global Cancer Trial Database for MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma
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Trial Identification
Brief Title: MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma
Official Title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single-Agent MLN0128 and the Combination of MLN0128+MLN1117 Compared With Everolimus in the Treatment of Adult Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor-Targeted Therapy
Study ID: NCT02724020
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of single-agent MLN0128 and the combination of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular endothelial growth factor (VEGF)-targeted therapy.
Detailed Description: The drugs being tested in this study are called MLN0128 and MLN1117. MLN0128 and MLN1117 are being tested to treat people who have mccRCC. This study will assess the efficacy and safety of MLN0128 and MLN1117 as well as how it is processed by the body in participants with advanced or mccRCC. The study will enroll approximately 96 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups: * Everolimus 10 mg once daily * MLN0128 30 mg once weekly * MLN0128 4 mg once daily for 3 days per week + MLN1117 200 mg once daily for 3 days per week All participants will be asked to take the study drug at the same time on each scheduled day. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 2 years after last participant is randomized, or when the last participant discontinues study treatment (approximately 3 years). Participants will make multiple visits to the clinic including a follow-up visit 30 to 40 days after receiving their last dose of study drug or prior to start of subsequent anticancer therapy for safety assessment. Participants will then be followed for Progression Free and Overall Survival.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Florida Cancer Specialists-Broadway, Venice, Florida, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
Hackensack University Medical Center PARTNER, Hackensack, New Jersey, United States
The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital, Columbus, Ohio, United States
Tennessee Oncology, Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders, Weatherford, Texas, United States
CancerCare Manitoba, Winnipeg, Manitoba, Canada
McMaster University, Hamilton, Ontario, Canada
Fakultni nemocnice u sv. Anny v Brne, Brno, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice v Motole, Prague 5, , Czechia
Groupe Hospitalier Saint Andre - Hopital Saint Andre, Bordeaux cedex, Aquitaine, France
ICL-Alexis Vautrin, Departement dOncologie Medicale, Vandoeuvre les Nancy Cedex, Meurthe Et Moselle, France
Groupe Hospitalier Pitie-Salpetriere, Paris cedex 13, Paris, France
Institut de Cancerologie de l'Ouest Paul Papin, Angers Cedex 9, PAYS DE LA Loire, France
Clinique Victor Hugo - Centre Jean Bernard, Le Mans Cedex 02, Sarthe, France
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS, Padova, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Beskidzkie Centrum Onkologii im.Jana Pawla II, Bielsko-Biala, , Poland
Instytut MSF, Ulica Pilota Stanislawa Wigury 19, Lodz, , Poland
Hospital Duran i Reynals, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
MD Anderson Cancer Centre, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Royal Devon and Exeter Hospital (Wonford), Exeter, Devon, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust, Blackburn, England, United Kingdom
Barts Hospital, London, Greater London, United Kingdom
The Christie, Manchester, Greater Manchester, United Kingdom
Velindre Cancer Centre, Cardiff, South Glamorgan, United Kingdom
Royal Surrey County Hospital, Guildford, Surrey, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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