Neuroendocrine TumorsNCT04814732
Expanded Access Program of Surufatinib
A study testing Surufatinib in people with Neuroendocrine Tumors, run by Hutchmed at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Surufatinib
- How many people
- Not given
- Where
- 11 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Mercy Medical Center, Medical Oncology & Hematology
Baltimore, Maryland, 21202
Roswell Park Cancer Institute
Buffalo, New York, 14263
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Karmanos Cancer Center
Detroit, Michigan, 48201
Summit Medical Group
Florham Park, New Jersey, 07932
MidAmerica Cancer Care
Kansas City, Missouri, 64114
Intermountain Healthcare
Murray, Utah, 84107
Providence Cancer Institute Franz Clinic, Providence Health & Services
Portland, Oregon, 97213
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Intermountain Cancer Center
St. George, Utah, 84790
About this study
Official title: An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors
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.
Read the 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 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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Surufatinib
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
HMP-012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marjo Hahka-Kemppinen, MD, Study chair, Hutchison Medipharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814732
- Sponsor's protocol ID
- 2020-012-GLOB3
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT04814732
- Acronym / sponsor ID
- 2020-012-GLOB3
- Conditions
- Neuroendocrine Tumors
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurufatinibHMP-012 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjo Hahka-Kemppinen, MD study chair
Hutchison Medipharma Limited
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surufatinib in people with Neuroendocrine Tumors, run by Hutchmed at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.