A Study of AL2846 on Tolerance and Pharmacokinetics

NCT ID: NCT02779699

Last Updated: 2019-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AL2846

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

Group Type EXPERIMENTAL

AL2846

Intervention Type DRUG

AL2846 p.o. qd

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AL2846

AL2846 p.o. qd

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yuankai Shi, doctor

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yuankai Shi, doctor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AL2846-I-0001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A New Drug Used for Advanced Cancer
NCT03447145 UNKNOWN PHASE1