TumorPhase 1HMPLNCT02133157
Phase I Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
A Phase 1 study testing Sulfatinib in people with Tumor, run by Hutchison Medipharma Limited at 1 site in China.
Trial summary
Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity has demonstrated potent inhibitory effects on multiple human tumor xenografts. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tumor
- 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
- 71 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Oct 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •≥ 18 and ≤ 70 years of age
- Histological or cytological confirmed solid malignant tumor
- ECOG performance status of 0-2
- Standard regimen failed or no standard regimen available
- Life expectancy of more than 12 weeks
- LVEF ≥ 50%
Who cannot join
- Pregnant or lactating women
- Adequate hepatic, renal, heart, and hematologic functions (platelets <75 × 109/L, neutrophil <1.5 × 109/L, hemoglobin < 90g/dl ,serum creatinine within upper limit of normal(ULN), total bilirubin and serum transaminase within upper limit of normal(ULN), and PT, APTT, TT, Fbg normal
- Any factors that influence the usage of oral administration
- Evidence of uncontrolled CNS metastasis
- Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
- Abuse of alcohol or drugs
Show all 14Show fewer
- Less than 4 weeks from the last clinical trial
- Previous treatment with VEGF/VEGFR inhibition
- Disability of serious uncontrolled intercurrence infection
- Uncontrolled hemorrhage in GI
- Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
- Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG
- Bone fracture or wounds that was not cured for a long time
- Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Safety and Pharmacokinetics of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity has demonstrated potent inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and recommended dose for phase II ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-012 at single doses and multiple doses .
Read the detailed description
This will be an open-label, phase I study. This study will evaluate the safety and pharmacokinetics of HMPL-012 after a single administration followed by a 28-Day continuous course of therapy; evaluate the safety and preliminary efficacy in an open-label administration of at the MTD. All subjects of this study will be permitted to continue therapy with only safety monitoring and monthly assessments for progression, if the product is well tolerated and the subject has stable disease or better
- Conditions
- Tumor
- Being tested
- Sulfatinib
- Keywords
- tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfatinibDrug
Also called HMPL-012
Sulfatinib is a capsule in the form of25, 50mg , 100mg; oral, once a day
| Study group | Role | What they receive |
|---|---|---|
| Sulfatinib capsule | Experimental | cohort 1: Sulfatinib single oral dosing;after 7days,Sulfatinib continuous oral dosing ( once a day) 28days as a cycle. Receives: Drug: Sulfatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating
The primary endpoint is evaluation of safety during the first 28-day cycle 1 of therapy following the initiation of multiple dosing of HMPL-012. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate
Measured: 1-28days after every drug administration
Secondary outcomes (1)
To measure the plasma concentration of HMPL-012 in single and repeated doses
In the study of single-dose, full PK profiles of HMPL-012 will be obtained following administration of a single oral dose of HMPL-012 on Day 1 to Day 3. At multiple-dose, PK sampling will include a pre-dose and at the 1,4,8,12 hour time points on days 1,14,28 of dosing in the first 28-Day cycle of therapy, and pre-dose on days 2, 3, 7, 15 and 29 of the first 28-Day cycle of therapy and pre-dose on days 56 of the cycle 2.
Measured: Day 1-3 Single Dose and Day 1-56 Steady State
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startApr 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming J Xu, PHD, Principal investigator, Academy of Military Medical Affiliated Hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133157
- Sponsor's protocol ID
- 2009-012-00CH1
- Acronym
- HMPL
- Status last verified
- Jul 2020
- First submitted
- 8 Mar 2014
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Safety and Pharmacokinetics of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02133157
- Acronym / sponsor ID
- HMPL / 2009-012-00CH1
- Conditions
- Tumor
- Keywords
- tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 May 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.
Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity has demonstrated potent inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and recommended dose for phase II ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-012 at single doses and multiple doses .
Detailed description
This will be an open-label, phase I study. This study will evaluate the safety and pharmacokinetics of HMPL-012 after a single administration followed by a 28-Day continuous course of therapy; evaluate the safety and preliminary efficacy in an open-label administration of at the MTD. All subjects of this study will be permitted to continue therapy with only safety monitoring and monthly assessments for progression, if the product is well tolerated and the subject has stable disease or better
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulfatinib capsule | Experimental | Drug: Sulfatinibcohort 1: Sulfatinib single oral dosing;after 7days,Sulfatinib continuous oral dosing ( once a day) 28days as a cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- •≥ 18 and ≤ 70 years of age
- Histological or cytological confirmed solid malignant tumor
- ECOG performance status of 0-2
- Standard regimen failed or no standard regimen available
- Life expectancy of more than 12 weeks
Key exclusion criteria (14 listed)
- Pregnant or lactating women
- Adequate hepatic, renal, heart, and hematologic functions (platelets <75 × 109/L, neutrophil <1.5 × 109/L, hemoglobin < 90g/dl ,serum creatinine within upper limit of normal(ULN), total bilirubin and serum transaminase within upper limit of normal(ULN), and PT, APTT, TT, Fbg normal
- Any factors that influence the usage of oral administration
- Evidence of uncontrolled CNS metastasis
- Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
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-012Sulfatinib is a capsule in the form of25, 50mg , 100mg; oral, once a day | Drug | Sulfatinib capsule |
Primary outcome
To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating
Time frame: 1-28days after every drug administration
The primary endpoint is evaluation of safety during the first 28-day cycle 1 of therapy following the initiation of multiple dosing of HMPL-012. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate
1 secondary outcome
To measure the plasma concentration of HMPL-012 in single and repeated doses
Time frame: Day 1-3 Single Dose and Day 1-56 Steady State
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 8 Jul 2020.
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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.
Ming J Xu, PHD principal investigator
Academy of Military Medical Affiliated Hopital
1 site 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 Tumor, run by Hutchison Medipharma Limited at 1 site 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 6 inclusion and 14 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 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating (time frame: 1-28days after every drug administration). 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 8 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.