Expanded Access Program of Surufatinib
Primary Purpose
Neuroendocrine Tumors
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Surufatinib
Sponsored by
About this trial
This is an expanded access trial for Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Rocky Mountain Cancer Center
- Mercy Medical Center, Medical Oncology & Hematology
- Karmanos Cancer Center
- MidAmerica Cancer Care
- Summit Medical Group
- Roswell Park Cancer Institute
- Providence Cancer Institute Franz Clinic, Providence Health & Services
- Avera Cancer Institute
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
- Intermountain Healthcare
- Intermountain Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04814732
Brief Title
Expanded Access Program of Surufatinib
Official Title
An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchmed
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Surufatinib
Intervention Description
HMP-012
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjo Hahka-Kemppinen, MD
Organizational Affiliation
Hutchison Medipharma Limited
Official's Role
Study Chair
Facility Information:
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Mercy Medical Center, Medical Oncology & Hematology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
MidAmerica Cancer Care
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Summit Medical Group
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Providence Cancer Institute Franz Clinic, Providence Health & Services
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Intermountain Healthcare
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Intermountain Cancer Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Program of Surufatinib
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