A Study Evaluating the Safety, Tolerability of LPM3480226 Tablets in Patients With Advanced Solid Tumors
NCT03844438 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2019-02-20
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Nanjing Bangnuo Biotechnology Co. Ltd
collaborator OTHER -
Luye Pharma Group Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-18
- Primary Completion
- 2020-10-28
- Completion
- 2022-03-01
Countries
- China
Study Locations
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