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First-in-human Phase I Study of a Selective c-Met Inhibitor PLB1001

NCT02896231 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-11-22

No results posted yet for this study

Summary

This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1001.

Conditions

Interventions

DRUG

PLB1001

PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.

Sponsors & Collaborators

  • Beijing Pearl Biotechnology Limited Liability Company

    lead INDUSTRY

Principal Investigators

  • Yilong Wu, MD · Guangdong Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02896231 on ClinicalTrials.gov