Open-label Study of Surufatinib in Japanese Patients

NCT05077384 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2020-012-00JP1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Neuroendocrine Tumors; Non-hematologic Malignancy

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to 2 years

Secondary Outcomes (3)

• Observed plasma concentrations of surufatinib which will be assessed by the Cmax, tmax, AUC, Cmin and CL/F

  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

  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.

  Up to 2 years

Study Arms (1)

Surufatinib

EXPERIMENTAL

Oral surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day1

Drug: Surufatinib

Interventions

Surufatinib DRUG

Surufatinib 300 mg oral once daily

Also known as: HMPL-012, sulfatinib

Surufatinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented disease as follows:
• Part 1: unresectable, locally advanced or metastatic nonhematologic malignancy that is relapsed/refractory to or intolerant of established therapies known to provide clinical benefit
• Part 2: locally advanced or metastatic, low (grade 1) or intermediate (grade 2) grade NETs that have been previously treated with at least 1 line of systemic therapy
• Has radiologic evidence of progressive tumour within 12 months of study enrolment
• Is willing and able to provide informed consent
• Is ≥20 years of age
• Has measurable lesions according to RECIST Version 1.1
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception

You may not qualify if:

• Women who are pregnant and lactating, or possibly pregnant.
• Has a history of interstitial lung disease (ILD)/noninfectious pneumonitis, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
• Known active viral hepatits
• Has an AE due to previous anti-tumour therapy that has not recovered to ≤CTCAE Grade 1, except alopecia and peripheral neurotoxicity with ≤CTCAE Grade 2 caused by platinum chemotherapy
• Uncontrollable hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive medication
• Gastrointestinal disease or condition within 6 months prior to first dose
• Has a history or presence of a serious haemorrhage (\>30 mL within 3 months) or haemoptysis (\>5 mL blood within 4 weeks)
• Clinically significant cardiovascular disease.
• Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease (SD) for 14 days or longer; patients requiring steroids within 4 weeks prior to start of study treatment will be excluded.
• A high risk of bleeding at screening due to tumour invasion into major vessels, such as pulmonary artery, the superior vena cava, or the inferior vena cava, as determined by investigators.
• Has arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing, or thromboembolic events (including stroke and/or transient ischaemic attack) within 12 months prior to first dosing.

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (12)

Kyushu University Hospital

Fukuoka, 812-0054, Japan

Location

Fukuoka Sanno Hospital

Fukuoka, 814-0001, Japan

Location

Kagawa University Hospital

Kagawa, 761-0793, Japan

Location

National Cancer Centre Hospital East

Kashiwa-shi, 277-8577, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Kyorin University Hospital

Mitaka, 181-8611, Japan

Location

Aichi Cancer Centre

Nagoya, 464-8681, Japan

Location

Kansia Electric Power Hospital

Osaka, 553-0003, Japan

Location

Hokkaido University Hospital

Sapporo, 060-8648, Japan

Location

Tohoku University Hospital

Sendai, 890-8574,, Japan

Location

National Cancer Centre Hospital

Tokyo, 104-004, Japan

Location

Yokohama City University Hospital

Yokohama, 236-0004, Japan

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• William Schelman, MD

  Hutchmed

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 14, 2021
• Study Start: September 2, 2021
• Primary Completion: September 6, 2024
• Study Completion: January 17, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (12)