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Safety, Tolerability and Pharmacokinetic Profile of BPI-15086 in EGFR T790M Mutation-positive NSCLC Patients

NCT02914990 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-07-18

No results posted yet for this study

Summary

The main objective of this study is to evaluate the safety and tolerability of BPI-15086.

Conditions

Interventions

DRUG

BPI-15086

BPI-15086 is administered once daily with a starting dose of 25 mg in a 21-day cycle. When tolerated, increasing doses of BPI-15086 will be tested in subsequent cohorts, until a maximum tolerated dose is determined.

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-29
Primary Completion
2019-03-07
Completion
2019-03-07

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 NCT02914990 on ClinicalTrials.gov