Neuroendocrine TumorsPhase 1NCT02267967
Phase Ib/II Study of Sulfatinib in Treating Advanced Neuroendocrine Tumors
A Phase 1 study testing Sulfatinib in people with Neuroendocrine Tumors, run by Hutchison Medipharma Limited at 7 sites in China.
Trial summary
a multicenter, open-label phase Ib study to determine the safety, tolerability and preliminary efficacy of Sulfatinib 300 mg once a day in treating advanced neuroendocrine tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Sulfatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 7 sitesChina
- Study dates
- 31 Oct 2014to 23 Aug 2017
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the study and voluntarily sign the informed consent form;
- Be at least 18 years old;
- Have a confirmed histological or cytological diagnosis of low- or intermediate-grade advanced NETs (unresectable or metastatic), for which standard treatment has failed or cannot be received. The NETs must meet the following criteria: (a) be GEP-NETs or NETs with the primary lesion located in tissue other than the lung or thymus (including unknown primary lesion location), with a mitotic count of ≤ 20/10 High Power Field [HPF] and a Ki67 index of ≤ 20%; or (b) be NETs of the lung or thymus (carcinoid) with a mitotic count of ≤ 10/10 High Power Field [HPF])
- Have measurable lesions (according to RECIST 1.1);
- Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale;
- Have expected survival of more than 12 weeks;
- Female patients with reproductive potential must agree to use an effective contraceptive method, for example, double-barrier device, condom, oral or injection birth control medication or intrauterine device, during the study and for 90 days after study completion.
Who cannot join
- Absolute neutrophil count (ANC) of < 1.5×109/L, or platelet count of < 100 ×109/L, or hemoglobin < 9 g/dL;
- Serum total bilirubin > 1.5 times the upper limit of normal (ULN);
- ALT, AST or ALP > 2.5 ULN without hepatic metastases or ALT, AST or ALP > 5 ULN with hepatic metastases
- Clinically significant serum potassium (regardless of potassium agent supplementation); serum calcium (ionic or binding to albumin post-adjusted) or clinically significant abnormal serum magnesium (regardless of magnesium agent supplementation);
- Serum creatinine > 1.5 ULN (with the exception of CCR ≥ 60 ml/min based on 24-hour urine collection);
- Urine protein > 2+, or 24-hour urine protein quantity >1 gram;
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- Uncontrolled hypertension, defined as: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90mmHg;
- International Normalized Ratio (INR) > 1.5 ULN or activated partial thromboplastin time (aPTT) > 1.5 ULN. INR is only for patients not receiving anticoagulant therapy;
- History or presence of digestive tract diseases, including active gastric/duodenal ulcer or ulcerative colitis, or active hemorrhage of an unresected gastrointestinal tumor, or an evaluation by investigators of having any other condition that could possibly result in gastrointestinal tract hemorrhage or perforation;
- History or presence of serious hemorrhage (> 30 ml within 3 months), hemoptysis (> 5 ml fresh blood within 4 weeks) or a thromboembolic event (including transient ischemic attack) within 12 months;
- Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction within 6 months prior to enrolment, severe/unstable angina pectoris or coronary artery bypass grafting, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment or left ventricular ejection fraction (LVEF) < 50%;
- Other malignancies within the previous 5 years, with the exception of basal cell carcinoma, squamous-cell carcinoma post radical resection, or cervical carcinoma in situ;
- Anti-tumor therapies within 4 weeks prior to the initiation of investigational treatment, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
- Palliative radiotherapy for a bone metastasis lesion within 2 weeks prior to the initiation of investigational treatment;
- Surgery prior to enrolment within 28 days prior to the initiation of investigational treatment or unhealed surgical incision;
- Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for hair loss);
- Clinically significant active infection;
- Human immunodeficiency virus (HIV) infection;
- History of clinically significant hepatic diseases, including viral hepatitis, (Hepatitis B carriers with active HBV infection, i.e., HBV DNA positive [>1×104/ml]; Hepatitis C virus infection with HBV RNA positive [>1×103/ml]); or other types of hepatitis, and liver cirrhosis.
- Women who are pregnant or lactating;
- Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of disease stability of longer than 14 days;
- Inability to orally take medicine, dysphagia or an active gastric ulcer resulting from previous surgery or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product;
- Receive investigational treatment in another clinical study within the 4 weeks prior to enrolment;
- Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at high risk.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
the 307 Hospital of People's Liberation Army
Beijing, Beijing Municipality, 100071
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
West China Hospital, Sichuan University
Chengdu, Sichuan, 610047
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
The first affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, 310006
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Multi-Center, Open-Label, Phase Ib/II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Sufatinib in Treating Advanced Neuroendocrine Tumors
a multicenter, open-label phase Ib study to determine the safety, tolerability and preliminary efficacy of Sulfatinib 300 mg once a day in treating advanced neuroendocrine tumors
Read the detailed description
The study population is patients with low- or intermediate-grade (G1 or G2) advanced NET who have failed in standard treatment or are unable to receive standard treatment.Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. Investigators will evaluate the clinical tumor response to Sulfatinib, and if investigators determine that the patient can benefit from the continuation of treatment, the patient will continue the Sulfatinib treatment. The duration of study will be 2 years. At the time of study completion, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with Sulfatinib with the agreement of the sponsor.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Sulfatinib
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfatinibDrug
Also called HMPL-012, Surufatinib
Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Sulfatinib | Experimental | Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. Receives: Drug: Sulfatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AE/SAEs
the safety of Sulfatinib
Measured: from day 1 of first dosing to 30 days after permanent discontinuation of Sulfatinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study start31 Oct 2014
- Primary completion23 Aug 2017
- Study completion23 Aug 2017
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Li, MD, Study director, Hutchison Medi Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267967
- Sponsor's protocol ID
- 2014-012-00CH1
- Status last verified
- Nov 2018
- First submitted
- 10 Oct 2014
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Phase Ib/II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Sufatinib in Treating Advanced Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT02267967
- Acronym / sponsor ID
- 2014-012-00CH1
- Conditions
- Neuroendocrine Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2014 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 20 Oct 2014 (estimated)
- 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.
a multicenter, open-label phase Ib study to determine the safety, tolerability and preliminary efficacy of Sulfatinib 300 mg once a day in treating advanced neuroendocrine tumors
Detailed description
The study population is patients with low- or intermediate-grade (G1 or G2) advanced NET who have failed in standard treatment or are unable to receive standard treatment.Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. Investigators will evaluate the clinical tumor response to Sulfatinib, and if investigators determine that the patient can benefit from the continuation of treatment, the patient will continue the Sulfatinib treatment. The duration of study will be 2 years. At the time of study completion, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with Sulfatinib with the agreement of the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulfatinib | Experimental | Drug: SulfatinibSulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fully understand the study and voluntarily sign the informed consent form;
- Be at least 18 years old;
- Have a confirmed histological or cytological diagnosis of low- or intermediate-grade advanced NETs (unresectable or metastatic), for which standard treatment has failed or cannot be received. The NETs must meet the following criteria: (a) be GEP-NETs or NETs with the primary lesion located in tissue other than the lung or thymus (including unknown primary lesion location), with a mitotic count of ≤ 20/10 High Power Field [HPF] and a Ki67 index of ≤ 20%; or (b) be NETs of the lung or thymus (carcinoid) with a mitotic count of ≤ 10/10 High Power Field [HPF])
- Have measurable lesions (according to RECIST 1.1);
- Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale;
Key exclusion criteria (24 listed)
- Absolute neutrophil count (ANC) of < 1.5×109/L, or platelet count of < 100 ×109/L, or hemoglobin < 9 g/dL;
- Serum total bilirubin > 1.5 times the upper limit of normal (ULN);
- ALT, AST or ALP > 2.5 ULN without hepatic metastases or ALT, AST or ALP > 5 ULN with hepatic metastases
- Clinically significant serum potassium (regardless of potassium agent supplementation); serum calcium (ionic or binding to albumin post-adjusted) or clinically significant abnormal serum magnesium (regardless of magnesium agent supplementation);
- Serum creatinine > 1.5 ULN (with the exception of CCR ≥ 60 ml/min based on 24-hour urine collection);
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 |
|---|---|---|
| SulfatinibAlso: HMPL-012, SurufatinibSulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. | Drug | Sulfatinib |
Primary outcome
Incidence and severity of AE/SAEs
Time frame: from day 1 of first dosing to 30 days after permanent discontinuation of Sulfatinib
the safety of Sulfatinib
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jing Li, MD study director
Hutchison Medi Pharma
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sulfatinib in people with Neuroendocrine Tumors, run by Hutchison Medipharma Limited at 7 sites in China.
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 7 inclusion and 24 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: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Incidence and severity of AE/SAEs (time frame: from day 1 of first dosing to 30 days after permanent discontinuation of Sulfatinib). It is what the study was designed to measure, not a finding.
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 13 Nov 2018.