Public trial registry of the CCC-Munich

Trial 16349 BAY 80-6946

Trial Trial design Status In-/Exclusion Therapy Participants Documents Permissions Tumorboards

Trial
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Trial acronym
:
16349 BAY 80-6946
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Full title
:

Phase-II-PI3K-Inhibitor bei rezidivierter, indolenter oder aggressiver NHL

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Description
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Es können nur noch Patienten mit follikulärem Lymphom in den PART B der Studie eingeschlossen werden. Der PART A ist geschlossen.
Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY 80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas
Offene, unkontrollierte Phase-II-Studie mit intravenösem PI3K-Inhibitor BAY 80-6946 in Patienten mit rezidivierten, trägen oder aggressiven Non-Hodgkin-Lymphomen

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Primary endpoints
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Secondary endpoints
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EudraCT number
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DRKS number
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Unknown
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NCT number
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ISRCTN number
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Unknown
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Responsible organization
:
Medizinische Klinik III, Telefon: 089440072551
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Legal basis
:
AMG interventional
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Registered by
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NASSEH-DA ()
Indications
Classification Code Description
ICD-10-GM C85.- Sonstige und nicht näher bezeichnete Typen des Non-Hodgkin-Lymphoms
- Bloodcancer (leukemia, lymphoma)
In-/Exclusion (Edit)
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Criterion for Inclusion
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Unknown
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Criterion for exclusion
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Unknown
Trial design
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IIT (sponsored by KUM)
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No
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Sponsor status
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Commercial
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Trial type
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Interventional
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Blinding type
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Open
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Phase
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II
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Center design
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Polycentric
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Treatment arms count
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Unknown
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Sample size
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120
Status
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Status
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Recruitment finished
Votes
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Institutional review board - vote
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Unknown
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Institutional review board - reference number
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PEI - vote
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Unknown
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PEI - reference number
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BfArM - vote
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Unknown
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BfArM - reference number
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Initiiation & lock
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Date of lock (planned / actual)
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Unknown / Unknown
Recruitment
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Time period (from / to)
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Unknown / Unknown
Therapy
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Therapy line
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Unknown
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Therapy Category
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Therapy
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Tumorboards (Edit)
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:
Dermatology Endocrinology Gastrointestinal
Gynecological Hematology KHT
Liver Lung Neurooncological
Pediatry Ortho. / Sarkoma Urological
Additionally involved centers (Edit)
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Pharmacy Radiology
Institut für Labormedzin Transfusiology
Radiotherapy Nuclear medicine
Participants
Function Prename Surname Organization