This is a multi-center, non-randomized and open-label phase I/IIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed or refractory non-hodgkin lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Specified dose on specified days
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hosptital
Zhengzhou, Henan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0
Time frame: Through study completion,an average of 3 years
Incidence, type, and severity of dose-limiting toxicities (DLTs);
Time frame: Through study completion,an average of 3 years
Recommended Phase 2 Doses(RP2Ds) and/or maximum tolerated doses(MTDs).
Time frame: Through study completion,an average of 3 years
ORR assessed according to the Lugano criteria (Cheson 2014).
Time frame: Through study completion,an average of 3 years
PK parameters: maximum concentration (Cmax)
Time frame: Through study completion,an average of 3 years
PK parameters: time to maximum concentration (Tmax)
Time frame: Through study completion,an average of 3 years
PK parameters: half-life (T1/2)
Time frame: Through study completion,an average of 3 years
PK parameters: area under the concentration-time curve (AUC0-∞ and AUC0-t)
Time frame: Through study completion,an average of 3 years
PK parameters: apparent clearance (CL/F)
Time frame: Through study completion,an average of 3 years
PK parameters: apparent volume of distribution during terminal phase (Vz/F)
Time frame: Through study completion,an average of 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
PK parameters:Steady-state PK parameters
Time frame: Through study completion,an average of 3 years
The overall response rate (ORR) assessed according to the Lugano criteria (Cheson 2014).
Time frame: Through study completion,an average of 3 years
Complete response rate (CRR) assessed according to the Lugano criteria (Cheson 2014).
Time frame: Through study completion,an average of 3 years
Time to response (TTR) assessed according to the Lugano criteria (Cheson 2014).
Time frame: Through study completion,an average of 3 years
Duration of response (DOR) assessed according to the Lugano criteria (Cheson 2014).
Time frame: Through study completion,an average of 3 years
Progression-free survival (PFS) assessed according to the Lugano criteria (Cheson 2014).
Time frame: Through study completion,an average of 3 years
Overall survival (OS)
Time frame: Through study completion,an average of 3 years