CancerPhase 1HMPL-309NCT02601274
Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumor
A Phase 1 study testing Theliatinib in people with Cancer, run by Hutchison Medipharma Limited at 2 sites in China.
Trial summary
A Phase I, open-label, multicenter dose-escalation study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of hmpl-309 in patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- Theliatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2015to Dec 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathology confirmed solid tumors
- Failed to standard treatment or no standard treatments for uncontrolled, recurrent and/or metastatic advance tumor (whatever previous surgery conditions)
- Dose-escalation stage:
- <300mg/day cohort no requiremnet for pathological pattern >300mg/day cohort required NCSLC, head and net squamous carcinoma, or oesophageal carcinoma Dose-expansion stage required oesophageal carcinoma
- Age 18-75
- performance status of 0, or 1, and no worse within 7days
- Life expected >3 months
- written informed consent form voluntarily
Who cannot join
- Lab testing within 1 week before enrolled, hemoglobin <9 g/dL or , platelet count < 750,000/mm3 and<150000/mm3,
- Total bilirubin≥1.5× the upper limit of normal,
- Serum creatinine higher than normal range
- Diastolic pressure≥150mmHg or systolic pressure≥100mmHg whatever anti-hypertension drug used,
- Serum potassium (whenever potassium implemented) , serum calcium(ionic or albumin-type calcium) or serum magnesium outside normal ranges(whenever implemented)
- Within previous 4 weeks treated by systemic anti-tumor therapy, or radiotherapy, immune therapy, biological or hormonal therapy, and clinical trials. But exclude the below therapy, Prostate cancer treated by hormonal therapy such as GnRH(gonadotropin-releasing hormone) analogue or antagonist Hormone replacement therapy or oral contraceptive Palliative radiotherapy for bone metastasis within 2 weeks
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- Prior documental evidence of resistance to EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitors)
- Unrecovered from any previous therapy related toxicity to≤ CTCAE(Common Toxicity Criteria for Adverse Effects) 0 or 1or unrecovered from any previous surgery
- Any CNS(central nervous system) metastasis with uncontrolled symptoms
- Known dysphagia or drug malabsorption
- Active infections such as acute pneumonia, hepatitis B active period
- APTT (activated partial thromboplastin time) and/or INR(international normalized ratio), PT≥2 the upper limit of normal(not including patients treated by anticoagulation treatment)
- ocular surface diseases or dry eye syndrome
- skin disease with obvious symptoms and signs
- significant cardiovascular disease, including II-IV atrioventricular block, acute myocardial infarction within 6 months, significant angina or Coronary artery bypass graft
- Known existing interstitial lung disease
- Female patients who are pregnant or feeding, or childbearing potential patient with pregnant testing positive
- Any abnormal of clinical and laboratory so that patients unsuitable to attend the trial sine in the opinion of the investigator
- Patients unable to comply with the protocol since significant psychological or psychogenic abnormal
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
Sun-Yat-sen univercity cancer centre
Guangzhou, Guangdong, 510060
About this study
Official title: Open-label, Dose Escalation Phase I Study of Theliatinib (HMPL-309,Xiliertinib) in Patients With Advanced Solid Tumors
A Phase I, open-label, multicenter dose-escalation study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of hmpl-309 in patients with advanced solid tumors
Read the detailed description
There are two stages to this study: a dose-escalation stage and a dose-expansion stage.
Dose-escalation stage: hmpl-309 administered orally once every day(QD) to patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Dose-expansion stage: hmpl-309 administered orally 300mg once every day(QD) to patients which is only for patients with EGFR positive oesophageal carcinoma.
- Conditions
- Cancer
- Being tested
- Theliatinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheliatinibDrug
Also called HMPL-309,xiliertinib
Theliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | Theliatinib investigational product once a day (QD) will be orally administrated on a 28-day cycle There are 7 dose cohorts,including120mg/160mg/200mg/220mg/300mg/400mg/500mg, QD in the dose escalation stage . Receives: Drug: Theliatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of all types/grades of adverse events
for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation
Measured: from first patient in till 30 days after the last patient last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: the change of clinical development plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601274
- Sponsor's protocol ID
- 2014-309-00CH1
- Acronym
- HMPL-309
- Status last verified
- Feb 2019
- First submitted
- 20 Oct 2015
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Dose Escalation Phase I Study of Theliatinib (HMPL-309,Xiliertinib) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02601274
- Acronym / sponsor ID
- HMPL-309 / 2014-309-00CH1
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the change of clinical development plan
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Nov 2015 (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 Phase I, open-label, multicenter dose-escalation study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of hmpl-309 in patients with advanced solid tumors
Detailed description
There are two stages to this study: a dose-escalation stage and a dose-expansion stage.
Dose-escalation stage: hmpl-309 administered orally once every day(QD) to patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Dose-expansion stage: hmpl-309 administered orally 300mg once every day(QD) to patients which is only for patients with EGFR positive oesophageal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Drug: TheliatinibTheliatinib investigational product once a day (QD) will be orally administrated on a 28-day cycle There are 7 dose cohorts,including120mg/160mg/200mg/220mg/300mg/400mg/500mg, QD in the dose escalation stage . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histopathology confirmed solid tumors
- Failed to standard treatment or no standard treatments for uncontrolled, recurrent and/or metastatic advance tumor (whatever previous surgery conditions)
- <300mg/day cohort no requiremnet for pathological pattern >300mg/day cohort required NCSLC, head and net squamous carcinoma, or oesophageal carcinoma Dose-expansion stage required oesophageal carcinoma
- Age 18-75
- performance status of 0, or 1, and no worse within 7days
Key exclusion criteria (19 listed)
- Lab testing within 1 week before enrolled, hemoglobin <9 g/dL or , platelet count < 750,000/mm3 and<150000/mm3,
- Total bilirubin≥1.5× the upper limit of normal,
- Serum creatinine higher than normal range
- Diastolic pressure≥150mmHg or systolic pressure≥100mmHg whatever anti-hypertension drug used,
- Serum potassium (whenever potassium implemented) , serum calcium(ionic or albumin-type calcium) or serum magnesium outside normal ranges(whenever implemented)
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 |
|---|---|---|
| TheliatinibAlso: HMPL-309,xiliertinibTheliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily | Drug | Single Group Assignment |
Primary outcome
incidence of all types/grades of adverse events
Time frame: from first patient in till 30 days after the last patient last visit
for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation
Results and safety
The study was stopped early (reason given: the change of clinical development plan). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Theliatinib in people with Cancer, run by Hutchison Medipharma Limited at 2 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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: the change of clinical development plan). 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.
What does the primary outcome measure?
incidence of all types/grades of adverse events (time frame: from first patient in till 30 days after the last patient last visit). 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 25 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.