Open-label Study of Surufatinib in Japanese Patients

Neuroendocrine Tumors Clinical Trial

Official title:

An Open-Label Study of Surufatinib in Japanese Patients With Neuroendocrine Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05077384
• Other study ID #: 2020-012-00JP1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Hutchmed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Key Inclusion Criteria:

1. Histologically or cytologically documented disease as follows:

1. Part 1: unresectable, locally advanced or metastatic nonhematologic malignancy that is relapsed/refractory to or intolerant of established therapies known to provide clinical benefit

2. 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

2. Has radiologic evidence of progressive tumour within 12 months of study enrolment

3. Is willing and able to provide informed consent

4. Is =20 years of age

5. Has measurable lesions according to RECIST Version 1.1

6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

7. Female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception

Key Exclusion Criteria:

1. Women who are pregnant and lactating, or possibly pregnant.

2. 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.

3. Known active viral hepatits

4. 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

5. Uncontrollable hypertension, defined as systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg, despite antihypertensive medication

6. Gastrointestinal disease or condition within 6 months prior to first dose

7. Has a history or presence of a serious haemorrhage (>30 mL within 3 months) or haemoptysis (>5 mL blood within 4 weeks)

8. Clinically significant cardiovascular disease.

9. 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.

10. 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.

11. 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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Non-hematologic Malignancy

Intervention

Drug:
• Surufatinib
Surufatinib 300 mg oral once daily

Locations

Country	Name	City	State
Japan	Fukuoka Sanno Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	Kagawa University Hospital	Kagawa
Japan	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	National Cancer Centre Hospital	Tokyo
Japan	Yokohama City University Hospital	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Hutchmed

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Up to 2 years
Secondary	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).	Up to 2 years
Secondary	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	Up to 2 years