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

AL2846

Yuankai Shi, doctor

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

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

A Study of AL2846 on Tolerance and Pharmacokinetics

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

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.

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 highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment

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).

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Bone Density Conservation Agents

All Drugs and Chemicals

Amino Acids

Zoledronic Acid

Diphosphonates

Tyrosine

AL2846 capsules 150 mg given orally, once daily in 28-day cycle, an analog of zoledronic acid injection (5ml:0mg) administered intravenously (IV) on Day 1 of each 28-day cycle.

An analog of AL2846 capsules 0 mg given orally, once daily in 28-day cycle, zoledronic acid injection (5ml:4mg) administered intravenously (IV) on Day 1 of each 28-day cycle.

AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met.

Zoledronic acid is a bisphosphonate drug that has a strong inhibition of bone resorption and a potential to promote bone formation, and can be used for bone metastasis caused by malignant tumors.

Zoledronic Acid Injection

Hongming Pan, Doctor

Xuhong Min, Doctor

Suxia Luo, Doctor

Yuansong Bai, Master

Wei Wang, Master

Yinyin Li, Doctor

Xinmei Yang, Master

Qinhong Zheng, Master

AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met, suggesting that its anti-tumor effect mainly inhibits the activation of key downstream oncogenic pathways by inhibiting expression of c-met, tumor angiogenesis and tumor cell migration.

A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis

A Randomized, Double-blind and Imitation, Parallel-control, Multicenter Phase II Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) With Bone Metastasis

The time from the randomization to the first occurrence of any meeting of bone-related event criteria.

OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.

Percentage of participants achieving complete response (CR) and partial response (PR).

The time when the participants first achieved complete or partial remission to disease progression.

Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

Referring to Brief pain inventory (BPI) and Verbal rating scale (VRS), the percentage of improvement in the average intensity of pain confirmed at week 8 and week 16 compared to the previous average intensity.

Relationship between drug efficacy and related biomarkers such as C-Met, FGFR, c-Kit, RET.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Irinotecan

Fluorouracil

Oxaliplatin

Calcium

Folic Acid

Vitamin B Complex

Calcium, Dietary

Tyrosine Kinase Inhibitors

Hormones

Topoisomerase I Inhibitors

Enzyme Inhibitors

Folinic Acid

Folate

Vitamin B9

AL2846 capsule administered orally,once daily in 28-day cycle; oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle；calcium folate 400mg/ ㎡ IV on day 1, day 15 in 28-day cycle；5-fu 2800mg/ ㎡ IV on day 1, 2, 15, 16 in 28-day cycle.

AL2846 capsule administered orally,once daily in 28-day cycle; irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle; calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle; 5-fu 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle.

AL2846 is a multi-target receptor tyrosine kinase inhibitor, which has obvious selectivity for c-met.

Calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle

Calcium folate

5-FU 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle.

5-FU

Oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle.

Irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle.

Yunpeng Liu, Doctor

This is a study to explore the safety, tolerance and efficacy of AL2846 capsules combined with mFOLFOLX6 or FOLFIRI standard chemotherapy regimen in subjects with advanced metastatic colorectal cancer.

A Study of AL2846 Capsule Combined With Standard Chemotherapy Regimen in Subjects With Advanced Colorectal Cancer

A Phase Ib Study to Evaluate the Efficacy and Safety of AL2846 Capsule Combined With Chemotherapy (mFOLFOX6 or FOLFIRI)Versus Placebo Combined With Chemotherapy in Subjects With Advanced Colorectal Cancer

PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of AL2846 on Tolerance and Pharmacokinetics	NCT02779699	Advanced Cancer	AL2846	18 Years - 65 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis	NCT04325776	Bone Metastatic...	AL2846 Zoledronic Acid...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study of AL2846 Capsule Combined With Standard Chemotherapy Regimen in Subjects With Advanced Colorectal Cancer	NCT04337879	Advanced Colore...	AL2846 Calcium folate 5-FU Oxaliplatin Irinotecan	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study of AL2846 on Tolerance and Pharmacokinetics	NCT02779699	Advanced Cancer	AL2846	18 Years - 65 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for al2846

Every month we try and update this database with for al2846 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for al2846

Every month we try and update this database with for al2846 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for al2846 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.