Study of Surufatinib in Combination with Gemcitabine in Pediatric Patients with Solid Tumors
Research type
Research Study
Full title
AN OPEN-LABEL, MULTICENTER PHASE 1/2 STUDY OF SURUFATINIB IN COMBINATION WITH GEMCITABINE IN PEDIATRIC, ADOLESCENT, AND YOUNG ADULT PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS
IRAS ID
1005765
Contact name
Nick Lawn
Contact email
Sponsor organisation
HUTCHMED Limited
Eudract number
2021-003602-41
Clinicaltrials.gov Identifier
Research summary
This study is to evaluate how safe and well tolerated a new drug called surufatinib is given in combination with a drug called gemcitabine, in children and adolescent patients (from birth to 17 years of age) with recurrent or refractory (does not respond to treatment) solid tumours or lymphoma.
There are two parts to the study. Part 1 is to identify the highest safe dose and/or the recommended phase 2 dose of surufatinib when given in combination with gemcitabine. Once the highest safe dose has been determined, part 2 of the study will begin.
Part 2 is to see how effective surufatinib in combination with gemcitabine is in stabilising or shrinking the tumour. In addition, the study will test how surufatinib in combination with gemcitabine affects the whole body.
Approximately 116 study participants will participate worldwide. Part 1 will enrol 2 to 6 participants per dose level cohort, with up to 4 cohorts. Part 2 will enrol 18 participants per cohort (defined by type of tumour or lymphoma)In part 1, all participants will receive surufatinib orally, daily in combination with gemcitabine intravenously (administration into a vein) on days 15 and 22 of cycle 1 (cycle 1 duration is 35-days) and days 1 and 8 of each subsequent cycle (cycle duration is 21-days). There are 3 dosing escalation levels and 1 de-escalation level.
In part 2, surufatinib will be administered orally, daily, at the dose level identified in part 1, in combination with gemcitabine (1000mg/m2) on days 1 and 8 of each cycle (cycle duration is 21-days).
The estimated duration of both parts 1 and 2 is 17 cycles, or until progressive disease, unacceptable toxicity or death; whichever comes first.
Follow-up on this study will be at 30 days, 6 months and 1 year after the last dose of protocol therapy.
This study is being funded by HUTCHMED Limited.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0620
Date of REC Opinion
11 Oct 2022
REC opinion
Further Information Unfavourable Opinion