All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Dose escalation: Dose Level -1: 5 mg.Dose Level 1:.10 mg.Dose Level 2: 15 mg.Dose Level 3: 20 mg.

Dose extension: Once the MTD was reached, the MTD-5 mg dose level was to be extended in order to enrol up to 12 patients (number of patients was to be determined regarding safety data) to better assess the toxicity profile, PK profile and antitumor activity.

Lucitanib

Jin Li, M.D.

Junning Cao, M.D.

This was a monocentric, open label, non-randomised, non-comparative, dose-finding phase I study

Methodology:

This was a monocentric, open label, non-randomised, non-comparative, dose-finding phase I study with a traditional 3+3 design, conducted in Chinese patients with advanced solid tumours without an established therapeutic alternative.This study was performed in strict accordance with Good Clinical Practice including the archiving of essential documents.

Study of the AL3810 in the Treatment of Advanced Solid Tumor

An Open-label, Dose-finding Phase I Study to Determine the Maximum Tolerated Dose, Recommended Dose, Pharmacokinetics, Pharmacodynamics of the Dual -VEGFR-FGFR Tyrosine Kinase Inhibitor, AL3810, Givenorally as Single Agent to Patients With Advanced Solid Tumours

To assess the tolerability of AL3810 in patients with advanced solid tumors

Metabolism profiling of AL3810 and its potential metabolites in plasma The potential food interaction on metabolism profile of AL 3810 in plasma

Tumor will be evaluated according to RECIST-1.1. CT or MRI can be used for tumor imaging at the investigator's discretion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of the AL3810 in the Treatment of Advanced Solid Tumor	NCT03117101	Advanced Solid ...	Lucitanib	18 Years - 70 Years	Haihe Biopharma Co., Ltd.
Study of the AL3810 in the Treatment of Advanced Solid Tumor	NCT03117101	Advanced Solid ...	Lucitanib	18 Years - 70 Years	Haihe Biopharma Co., Ltd.
Study of the AL3810 in the Treatment of Advanced Solid Tumor	NCT03117101	Advanced Solid ...	Lucitanib	18 Years - 70 Years	Haihe Biopharma Co., Ltd.

Spots Global Cancer Trial Database for tolerability pharmacokinetics