Expanded Access Program of Surufatinib

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04814732
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hutchison Medipharma Limited
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

John Kauh, MD
Principal Investigator Affiliation Hutchison Medipharma Limited
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Available
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rocky Mountain Cancer Center, Denver, Colorado

Status

Available

Address

Rocky Mountain Cancer Center

Denver, Colorado, 80218

Site Contact

Jennifer Hege

jennifer.hege@usoncology.com

303-385-2067

Baltimore, Maryland

Status

Available

Address

Mercy Medical Center, Medical Oncology & Hematology

Baltimore, Maryland, 21202

Site Contact

Alexandra Cline

acline@mdmercy.com

410-951-7956

Karmanos Cancer Center, Detroit, Michigan

Status

Available

Address

Karmanos Cancer Center

Detroit, Michigan, 48201

Site Contact

Taylor Brewer, CCRP

brewert@karmanos.org

313-576-8526

MidAmerica Cancer Care, Kansas City, Missouri

Status

Available

Address

MidAmerica Cancer Care

Kansas City, Missouri, 64114

Site Contact

Jennifer Ross

jross@maccsp.com

660-383-3197

Summit Medical Group, Florham Park, New Jersey

Status

Available

Address

Summit Medical Group

Florham Park, New Jersey, 07932

Site Contact

Michelle MacKenzie

mmackenzie@summithealth.com

973-538-5210

Roswell Park Cancer Institute, Buffalo, New York

Status

Available

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Site Contact

Roswell Park

ASKRPCI@roswellpark.org

800-767-9455

Portland, Oregon

Status

Available

Address

Providence Cancer Institute Franz Clinic, Providence Health & Services

Portland, Oregon, 97213

Site Contact

Katrina Herz

Katrina.Herz@providence.org

503-215-2617

Avera Cancer Institute, Sioux Falls, South Dakota

Status

Available

Address

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

Site Contact

Heidi Nickles

Heidi.Nickles@avera.org

605-322-3295

Dallas, Texas

Status

Available

Address

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246

Site Contact

Jonathan Huntzinger

Jonathan.huntzinger@usoncology.com

214-370-1942

Intermountain Healthcare, Murray, Utah

Status

Available

Address

Intermountain Healthcare

Murray, Utah, 84107

Site Contact

Tracy Taylor

tracy.taylor@imail.org

801-507-3953

Intermountain Cancer Center, Saint George, Utah

Status

Available

Address

Intermountain Cancer Center

Saint George, Utah, 84790

Site Contact

Emily Lowe

Emily.lowe@imail.org

435-251-4746

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