A Study of AL2846 on Tolerance and Pharmacokinetics | NCT02779699

NCT02779699

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Label	Type	Description	Intervention Names
AL2846	Experimental	AL2846 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: AL2846

Name	Type	Description	Arm Group Labels	Other Names
AL2846	Drug	AL2846 p.o. qd	AL2846

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Eligibility Module

Eligibility Criteria

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