A Study of AL2846 on Tolerance and Pharmacokinetics

NCT02779699 | Unknown Phase 1

• 1 other identifier: AL2846-I-0001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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 Outcomes (1)

• Objective Response Rate (ORR)

  each 56 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (1)

AL2846

EXPERIMENTAL

AL2846 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: AL2846

Interventions

AL2846 DRUG

AL2846 p.o. qd

AL2846

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Central Study Contacts

Yuankai Shi, doctor

CONTACT

syuankaipumc@126.com

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: May 16, 2016
• First Posted: May 20, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

CN (1)