Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumor

NCT02601274 | Terminated Phase 1

• 1 other identifier: 2014-309-00CH1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  from first patient in till 30 days after the last patient last visit

Other Outcomes (2)

• Area under the plasma concentration versus time curve (AUC)

  Day 1-3 Single Dose and Day 1-28 Steady State

• Peak Plasma Concentration (Cmax)

  Day 1-3 Single Dose and Day 1-28 Steady State

Study Arms (1)

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 .

Drug: Theliatinib

Interventions

Theliatinib DRUG

Theliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily

Also known as: HMPL-309,xiliertinib

Single Group Assignment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

Sun-Yat-sen univercity cancer centre

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: November 10, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)