Expanded Access Program of Surufatinib

Status:

NO_LONGER_AVAILABLE

Expanded Access Program of Surufatinib

Lead Sponsor:

Hutchmed

Conditions:

Neuroendocrine Tumors

Eligibility:

All Genders

12+ years

Brief Summary

This treatment protocol is intended to provide early access of surufatinib to patients with locally advanced or metastatic NETs for whom, in the opinion of their treating physician, other treatment op...

Detailed Description

Prior to any assessments, all subjects must provide a signed ICF. Prior to inclusion in the program, the patients must undergo all appropriate screening procedures to check for eligibility. Once elig...

Eligibility Criteria

Inclusion

Histologically or cytologically documented, well differentiated, locally advanced or metastatic NETs
The patient or parent/legal guardian (as appropriate) is willing and able to provide informed consent, and where required, the patient is willing to provide assent
≥12 years of age
In the opinion of the patient's treating physician, other treatment options or clinical trials in this indication are unsuitable
Patient has adequate bone marrow and organ function
Urine dipstick ≤1+ for proteinuria or ≤30 mg/dL in urinalysis,
ECOG ≤2 for adult patients (≥18 years of age), Karnofsky ≥60 for patients \>16 and \<18 years of age, and Lansky ≥60 for pediatric patients ≤16 years of age
For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and partner) to use a highly effective form(s) of contraception

Exclusion

Uncontrollable hypertension, as defined by local institution
Gastrointestinal disease or condition that the physician suspects may affect drug absorption
History or presence of a serious hemorrhage
Clinically significant cardiovascular disease
Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy
High risk of bleeding at screening due to tumor invasion
Arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing or thromboembolic events (including stroke and/or transient ischemic attack) within 6 months prior to first dosing
Received treatment with anticancer therapy, including investigational therapy, within 7 days or 5 half-lives (whichever is longer)
Received prior treatment with surufatinib
Inability to take medication orally
Any other clinically significant comorbidities that, in the judgment of the treating physician, could predispose the patient to safety risks

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04814732

Last Update

April 12 2024

Active Locations (11)

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Page 1 of 3 (11 locations)

Rocky Mountain Cancer Center

Denver, Colorado, United States, 80218

Mercy Medical Center, Medical Oncology & Hematology

Baltimore, Maryland, United States, 21202

Karmanos Cancer Center

Detroit, Michigan, United States, 48201