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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT04814732
Other study ID # 2020-012-GLOB3
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information

Verified date April 2024
Source Hutchmed
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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 options or surufatinib clinical trials in this indication are unsuitable. This EAP is currently available in the US only.


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 eligibility is confirmed, patients will receive treatment with surufatinib 300mg, orally (PO), daily (QD). All patients will undergo continuous monitoring for safety until the end of treatment. There is no pre-defined duration of treatment for each patient. Patients will be treated until progressive disease (as defined by treating physician), unacceptable toxicity, death, withdrawal from program, the treatment becomes commercially available, or halting of product development. A follow-up clinic visit is recommended for all patients approximately 30 days after last dose of treatment to complete the final safety assessments, as applicable.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: 1. Histologically or cytologically documented, well differentiated, locally advanced or metastatic NETs 2. 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 3. =12 years of age 4. In the opinion of the patient's treating physician, other treatment options or clinical trials in this indication are unsuitable 5. Patient has adequate bone marrow and organ function 6. Urine dipstick =1+ for proteinuria or =30 mg/dL in urinalysis, 7. 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 8. 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 Criteria: 1. Uncontrollable hypertension, as defined by local institution 2. Gastrointestinal disease or condition that the physician suspects may affect drug absorption 3. History or presence of a serious hemorrhage 4. Clinically significant cardiovascular disease 5. Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy 6. High risk of bleeding at screening due to tumor invasion 7. 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 8. Received treatment with anticancer therapy, including investigational therapy, within 7 days or 5 half-lives (whichever is longer) 9. Received prior treatment with surufatinib 10. Inability to take medication orally 11. Any other clinically significant comorbidities that, in the judgment of the treating physician, could predispose the patient to safety risks

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Surufatinib
HMP-012

Locations

Country Name City State
United States Mercy Medical Center, Medical Oncology & Hematology Baltimore Maryland
United States Roswell Park Cancer Institute Buffalo New York
United States Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Rocky Mountain Cancer Center Denver Colorado
United States Karmanos Cancer Center Detroit Michigan
United States Summit Medical Group Florham Park New Jersey
United States MidAmerica Cancer Care Kansas City Missouri
United States Intermountain Healthcare Murray Utah
United States Providence Cancer Institute Franz Clinic, Providence Health & Services Portland Oregon
United States Intermountain Cancer Center Saint George Utah
United States Avera Cancer Institute Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
Hutchmed

Country where clinical trial is conducted

United States, 

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