A Study of AL2846 on Tolerance and Pharmacokinetics

Advanced Cancer Clinical Trial

Official title:

Phase I Study of Tolerance and Pharmacokinetics of AL2846 in Patients With Advanced Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02779699
• Other study ID #: AL2846-I-0001
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2016
• Est. completion date: October 2020

Study information

• Verified date: May 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Yuankai Shi, doctor
• Email: syuankaipumc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study of AL2846,a C-met/Hepatocyte growth factor tyrosine kinase inhibitor,in patients with advanced cancer.

Description:

To study the pharmacokinetic characteristics of AL2846 in the human body; To recommend a reasonable dose and indication for subsequent research.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Histological documentation of Advanced solid tumors(especially Hepatocellular Carcinoma and Lung Cancer ),at least one measurable lesion (by RECIST1.1)

• Lack of the standard treatment or treatment failure

• 18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months

• 30 Days or more from the last cytotoxic therapy

• Main organs function is normal

• Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device,contraceptive and condom) throughout treatment and for at least 6 months after study is stopped;the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment,and the patients required to be non-lactating;Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped

• Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

• Patients suffering from other malignancies currently or ever, except for cured cervical carcinoma in situ, non-melanoma skin cancers

• Patients with factors that could affect oral medication (such as dysphagia,chronic diarrhea, intestinal obstruction etc.)

• Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now

• Blood pressure unable to be controlled ideally by one drug(systolic pressure=140 mmHg,diastolic pressure=90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including male QTc=450ms,female QTc=470ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification)

• Urine protein = ++,and 24-hour urinary protein excretion>1.0 g confirmed

• Patients with non-healing wounds or fractures

• Patients with drug abuse history and unable to get rid of or Patients with mental disorders

• History of immunodeficiency

• Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• AL2846
AL2846 p.o. qd

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The type of dose-limiting toxicity(ies) (DLT[s]) of AL2846	Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug :II °or above of kidney damage,III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever.	For 4 weeks for DLTs
Primary	Pharmacokinetics of AL2846 (in plasma)	In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H4/H8/H11/H24/H34/H48/H58/H72/H96/H120/H168 (H means Hour). In the study of multiple-dose, full PK profiles will be obtained at D0/D1/D4/D7/D10/D13/D15/D18/D21/D24/D28 (D means Day).	up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Primary	The maximum tolerated dose (MTD) of AL2846	The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment	48 weeks
Secondary	Objective Response Rate (ORR)	Percentage of participants with OR based assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).	each 56 days up to intolerance the toxicity or PD (up to 24 months)