NCT03844438

A Study Evaluating the Safety, Tolerability of LPM3480226 Tablets in Patients With Advanced Solid Tumors

A Non-randomized, Open, Dose Escalation Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LPM3480226 Tablets in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a non-randomized, open, multiple administration and dose escalation phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetic/pharmacodynamics Characteristics of multiple oral administration of LPM3480226 in patients with advanced solid tumors., determine its dose-limiting toxicity and maximum tolerated dose, and initially observe its clinical effectiveness, and explore the metabolites in plasma after administration.

Detailed description

The primary objective of this study was to assess the safety and tolerability of LPM3480226 tablets after oral administration to patients with advanced solid tumors, and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of LPM3480226. A non-randomized, open, multiple dose escalation design was used with a total of five dose groups. The starting dose was 50 mg and the subsequent dose was increased according to the protocol of 100 mg , 200 mg , 400 mg , 600mg. Starting from the low-dose group, each subject received only one dose of the drug, and the next dose group study could only be performed if the previous dose group was completed and safe tolerance was confirmed. Subjects were given the corresponding doses in the order，bid，28 days as a cycle, to evaluate the safety and tolerability of multiple doses. After confirming the safety and tolerance of the dose group in the first administration cycle, the administration was continued for another cycle according to the dose, and the subjects were evaluated for the efficacy after the two-cycle administration, and the subjects who did not have disease progression and is well tolerated and the investigator believes that continued treatment can benefit, the patient may continue to receive the dose of the drug on a voluntary basis, with a maximum dose of no more than one year.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	LPM3480226	The starting dose was 50 mg and the subsequent dose was increased according to the protocol of 100 mg, 200 mg, 400 mg, 600mg.

Timeline

• Start date: 2018-12-18
• Primary completion: 2020-10-28
• Completion: 2022-03-01
• First posted: 2019-02-18
• Last updated: 2019-02-20

Locations

1 site across 1 country: China