- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02601274
Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumor (HMPL-309)
Open-label, Dose Escalation Phase I Study of Theliatinib (HMPL-309,Xiliertinib) in Patients With Advanced Solid Tumors
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China
- Beijing Cancer Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun-Yat-sen univercity cancer centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Single Group Assignment
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 .
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Theliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of all types/grades of adverse events
Time Frame: from first patient in till 30 days after the last patient last visit
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for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation
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from first patient in till 30 days after the last patient last visit
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the plasma concentration versus time curve (AUC)
Time Frame: Day 1-3 Single Dose and Day 1-28 Steady State
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Based on single-dose PK result, multi-dose stage subjects take HMPL-309 once a day or twice a day, PK samples are collected of a single oral dose of HMPL-309 on Day 1 to Day 3. At multiple-dose, Pharmacokinetics(PK) sampling will include a pre-dose and at the 0.5,2,4,6,8 hour time points on days 1,15,21of dosing in the first 21-Day cycle of therapy, and pre-dose on days 2,8,16,and 22 of the first 21-Day cycle of therapy
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Day 1-3 Single Dose and Day 1-28 Steady State
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Peak Plasma Concentration (Cmax)
Time Frame: Day 1-3 Single Dose and Day 1-28 Steady State
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Based on single-dose PK result, multi-dose stage subjects take HMPL-309 once a day or twice a day, PK samples are collected of a single oral dose of HMPL-309 on Day 1 to Day 3. At multiple-dose, Pharmacokinetics(PK) sampling will include a pre-dose and at the 0.5,2,4,6,8 hour time points on days 1,15,21of dosing in the first 21-Day cycle of therapy, and pre-dose on days 2,8,16,and 22 of the first 21-Day cycle of therapy
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Day 1-3 Single Dose and Day 1-28 Steady State
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014-309-00CH1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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