A Phase I study of Human Pharmacokinetics and Safety of ORY-1001
Research type
Research Study
Full title
A phase I study of Human Pharmacokinetics and Safety of ORY-1001, and LSD1 inhibitor, in relapsed or refractory acute leukaemia (AL)
IRAS ID
140382
Contact name
Tim Somervaille
Contact email
Sponsor organisation
Oryzon Genomics S.A.
Eudract number
2013-002447-29
Research summary
Mixed lineage leukemia is a very aggressive blood cancer with a poor prognosis and despite the availability of advanced treatment methods cure rates have stopped their progression over the last years.
ORY-1001 targets leukemic stem cells, induces differentiation, and provokes apoptosis to different degrees and could function well as a monotreatment for specific AML subtypes or more broadly as an adjuvant treatment to standard cytotoxic or differentiation therapy for AML.The current study is performed to characterize the pharmacokinetics, safety, tolerability and pharmacodynamics of ORY-1001 for oral intake at various doses to patients with relapsed / refractory AL and to establish the maximum tolerated dose.
This study will be performed to characterize the pharmacokinetics of ORY-1001 for oral intake.
ORY-1001 is not been brought into clinical development for haematological malignancies yet. This phase I part of the clinical study, CL01-ORY-1001, will include patients with a relapsed or refractory acute leukaemia at age 16 or above.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0830
Date of REC Opinion
10 Feb 2014
REC opinion
Further Information Favourable Opinion