NCT02601248

Brief Summary

First-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of Theliatinib .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Oct 2012

Typical duration for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 14, 2013

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

3.3 years

First QC Date

October 14, 2013

Last Update Submit

February 12, 2020

Conditions

Cancer

Keywords

safety, PK

Outcome Measures

Primary Outcomes (1)

  • Safety :the incidence of all adverse events by type and grade, abnormal laboratory changes

    for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation

    from day 1 of first dosing to 30days after permanent discontinuation of Thialitinib

Secondary 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)

Theliatinib

EXPERIMENTAL

Theliatinib investigational product once a day (QD) will be orally administrated on a 28-day cycle There are 5 dose cohorts,including120mg/160mg/200mg/220mg/300mg, QD in the dose escalation stage .

Drug: Theliatinib

Interventions

TheliatinibDRUG

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

Also known as: HMPL-309
Theliatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)
  • 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, AND\<1.5×109/L, platelet\<75×109/L, or Hb\<9g/dL,
  • 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 analogue or antagonist Hormone replacement therapy or oral contraceptive Palliative radiotherapy for bone metastasis within 2 weeks
  • Prior documental evidence of resistance to(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 ULN (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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Weiguo Su, PhD

    Hutchison Medipharm Limited

    STUDY CHAIR

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 14, 2013

First Posted

November 10, 2015

Study Start

October 1, 2012

Primary Completion

February 1, 2016

Study Completion

May 1, 2016

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)