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Brief Title: Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
Official Title: Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
Study ID: NCT01660451
Brief Summary: The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers. Quality of life will be a further objective of part B of the study. In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946. After an up to 28-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B). Treatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment. Thirty to 35 days after last study drug administration, a safety followup visit will be performed for the collection of adverse events (AEs) and concomitant medication data. Patients will be contacted quarterly to determine overall survival status up to 4 years after last patient completed treatment. Patients who discontinue study drug for reasons other than disease progression will enter the Active Assessment Follow-up period. The end of study notification to Health Authorities will be based on the completion of the collection of survival data. The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis (mandatory) and for central pathology review (part B), fresh biopsy tissue will also be collected if available.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Birmingham, Alabama, United States
, Gilbert, Arizona, United States
, Anaheim, California, United States
, Aurora, Colorado, United States
, Englewood, Colorado, United States
, Fort Collins, Colorado, United States
, Port Saint Lucie, Florida, United States
, Louisville, Kentucky, United States
, Detroit, Michigan, United States
, Saint Louis Park, Minnesota, United States
, Westbury, New York, United States
, Goldsboro, North Carolina, United States
, Canton, Ohio, United States
, San Antonio, Texas, United States
, Spokane, Washington, United States
, Garran, Australian Capital Territory, Australia
, Linz, , Austria
, Anderlecht, , Belgium
, Bruxelles - Brussel, , Belgium
, Gent, , Belgium
, Leuven, , Belgium
, Turnhout, , Belgium
, Wilrijk, , Belgium
, Sofia, , Bulgaria
, Saint John, New Brunswick, Canada
, Montreal, Quebec, Canada
, Montreal, Quebec, Canada
, Helsinki, , Finland
, Oulu, , Finland
, Tampere, , Finland
, Turku, , Finland
, Brest, , France
, Creteil, , France
, La Roche Sur Yon, , France
, Lille, , France
, PARIS cedex, , France
, Pessac, , France
, Pierre Benite, , France
, Poitiers, , France
, Rouen, , France
, Vandoeuvre-les-nancy, , France
, München, Bayern, Germany
, Potsdam, Berlin, Germany
, Münster, Nordrhein-Westfalen, Germany
, Recklinghausen, Nordrhein-Westfalen, Germany
, Mainz, Rheinland-Pfalz, Germany
, Dresden, Sachsen, Germany
, Berlin, , Germany
, Berlin, , Germany
, Athens, , Greece
, Hong Kong, , Hong Kong
, Shatin, , Hong Kong
, Budapest, , Hungary
, Budapest, , Hungary
, Kaposvar, , Hungary
, Galway, , Ireland
, Petach Tikva, , Israel
, Ramat Gan, , Israel
, Zerifin, , Israel
, Napoli, Campania, Italy
, Bologna, Emilia-Romagna, Italy
, Roma, Lazio, Italy
, Brescia, Lombardia, Italy
, Milano, Lombardia, Italy
, Torino, Piemonte, Italy
, Busan, Busan Gwang''yeogsi, Korea, Republic of
, Seoul, Seoul Teugbyeolsi, Korea, Republic of
, Seoul, , Korea, Republic of
, Christchurch, , New Zealand
, Gdynia, , Poland
, Krakow, , Poland
, Lisboa, , Portugal
, Kemerovo, , Russian Federation
, Moscow, , Russian Federation
, Nizhny Novgorod, , Russian Federation
, Omsk, , Russian Federation
, Saratov, , Russian Federation
, St. Petersburg, , Russian Federation
, Singapore, , Singapore
, Singapore, , Singapore
, Majadahonda, Madrid, Spain
, Marbella, Málaga, Spain
, Barcelona, , Spain
, Madrid, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Uddevalla, , Sweden
, Ankara, , Turkey
, Istanbul, , Turkey
, Izmir, , Turkey
, Izmir, , Turkey
, Cambridge, Cambridgeshire, United Kingdom
, Plymouth, Devon, United Kingdom
, Southampton, Hampshire, United Kingdom
, Harrow, London, United Kingdom
, Liverpool, Merseyside, United Kingdom
, Sutton, Surrey, United Kingdom
, Birmingham, West Midlands, United Kingdom
, Leeds, , United Kingdom
, Manchester, , United Kingdom
, Romford, , United Kingdom
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR