This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.
Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3, PDGFRa and c-Kit), mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target non-receptor kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms of clinical relevance. Patients will be randomized to receive treatment with either paclitaxel + Chiauranib or paclitaxel + placebo. Paclitaxel will be repeated every 21 days for a maximum of 6 cycles. Patients with objective response/stable disease after completing 6 courses of chemotherapy will continue Chiauranib or placebo until progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
454
50mg orally once daily
50mg orally once daily
at the first cycle, 60mg/m2, i.v infusion on day 1, 8 and 15 ; at the begining of the second cycle, after a comprehensive assessment , investigators decide whether to increase the dosage to 80mg/m2, i.v infusion on day 1, 8 and 15 ;
Fudan University Shanghai Cancer Center
Shanghai, China, China
RECRUITINGprogression-free survival (PFS)
From the first time of treatment until the date of first documented progression or date of death from any cause, whichever comes first (Assessed by IRC)
Time frame: assessed up to 1 years
overall survival (OS)
OS is defined as the length of time from treatment to death from any cause
Time frame: assessed up to 2 years
overall response rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: assessed up to 2 years
duration of response (DOR)
From the first date of response until the date of first documented progression
Time frame: assessed up to 2 years
Disease control rate (DCR)
DCR is defined as the Proportion of participants in partial, complete or stable desease according to RECIST 1.1. criteria
Time frame: assessed up to 2 years
Quality of life (QoL)
QoL assessed by EORTC QLQ-OV28
Time frame: assessed up to 2 years
Toxicity according to NCI CTCAE v5.0 criteria
tolerance of the treatment based on AE occurrence according to NCI CTCAE v5.0 criteria
Time frame: assessed up to 2 years
PK parameters of paclitaxel, chiauranib and M345
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PK parameters include but not limited to AUC, Cmax, Tmax etc.
Time frame: assessed up to 2 years