Open-label, dose escalation study to evaluate safety, tolerability pharmacokinetic and pharmacodynamic activity, and efficacy of Adrixetinib (Q702) in subjects with relapsed or refractory active chronic graft-versus-host disease (cGVHD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Administered orally
Hospital Clinic de Barcelona
Barcelona, Spain
RECRUITINGHospital General Universitario Gregorio Maranon
Madrid, Spain
RECRUITINGHospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Number of Participants with Dose-Limiting Toxicities (DLTs)
DLTs assessed for each dose level
Time frame: Cycle 1 (28 Days)
Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
AEs and SAEs assessed for each dose level.
Time frame: Cycle 1 (28 Days)
Pharmacokinetics (PK)
Maximum Observed Plasma Concentration (Cmax), area under the curve AUC of Q702 and its primary metabolites
Time frame: Estimated up to Cycle 1 (28 Days)
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Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
RECRUITINGClinica Universidad de Navarra
Pamplona, Spain
RECRUITINGHospital Universitario Marques de Valdecilla
Santander, Spain
RECRUITINGHospital Universitario Virgen del Rocio
Seville, Spain
RECRUITINGInstituto de Investigacion Sanitaria
Valencia, Spain
RECRUITING