This is a phase 1/2, open-label, multi-centre study of surufatinib in patients with unresectable, locally advanced, or recurrent nonhematologic malignancies who do not respond or are intolerant to standard of care.
The purpose of this study is to evaluate the tolerability and efficacy of surufatinib in Japanese patients. The study will be conducted in 2 parts: * Part 1 - evaluation of tolerability and safety of surufatinib and confirmation of the recommended clinical dose in Japanese patients with nonhematologic malignancies * Part 2 - evaluation of antitumor activity and confirmation of tolerability of surufatinib in Japanese patients with NETs All patients will be treated with oral surufatinib 300 mg QD in treatment cycles of 28 days starting on Cycle 1 Day 1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Surufatinib 300 mg oral once daily
Kyushu University Hospital
Fukuoka, Japan
Fukuoka Sanno Hospital
Fukuoka, Japan
Kagawa University Hospital
Kagawa, Japan
Part 1: Incidence of treatment-emergent adverse events (TEAEs) graded by the Investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
To evaluate surufatinib-related adverse events in patients with NETs
Time frame: Up to 2 years
Part 2: Objective response rate. This will be assessed on the proportion of participants with partial response or complete response as determined by the Investigator based on RECIST v1.1
The primary outcome of part 2 will be objective response rate in patients with NETs when treated with surufatinib
Time frame: Up to 2 years
Observed plasma concentrations of surufatinib which will be assessed by the Cmax, tmax, AUC, Cmin and CL/F
Blood sampling will be taken to measure levels of the study drug
Time frame: Up to 2 years
Progression Free Survival (PFS) which is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occurs first
The duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).
Time frame: Up to 2 years
Duration of Response (DOR) which will be defined as the time from the first response to disease progression documented after treatment initiation or death, whichever occurs first. DOR will include CR, CR plus CRi, overall response (OR), and CR plus CRh.
The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded
Time frame: Up to 2 years
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National Cancer Centre Hospital East
Kashiwa-shi, Japan
Kyoto University Hospital
Kyoto, Japan
Kyorin University Hospital
Mitaka, Japan
Aichi Cancer Centre
Nagoya, Japan
Kansia Electric Power Hospital
Osaka, Japan
Hokkaido University Hospital
Sapporo, Japan
Tohoku University Hospital
Sendai, Japan
...and 2 more locations