Advanced Cancer
Conditions
Brief summary
A study of AL2846,a C-met/Hepatocyte growth factor tyrosine kinase inhibitor,in patients with advanced cancer.
Detailed description
To study the pharmacokinetic characteristics of AL2846 in the human body; To recommend a reasonable dose and indication for subsequent research.
Interventions
DRUGAL2846
AL2846 p.o. qd
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The type of dose-limiting toxicity(ies) (DLT[s]) of AL2846 | For 4 weeks for DLTs | 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. |
| Pharmacokinetics of AL2846 (in plasma) | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) | 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). |
| The maximum tolerated dose (MTD) of AL2846 | 48 weeks | The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | each 56 days up to intolerance the toxicity or PD (up to 24 months) | 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). |
Countries
China
Contacts
Primary ContactYuankai Shi, doctor
Outcome results
None listed