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Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors

NCT02675491 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-12-16

No results posted yet for this study

Summary

This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.

Conditions

  • Advanced Solid Malignant Tumors

Interventions

DRUG

DS-6051b

Drug: DS-6051b 400 mg or 800 mg daily

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-10
Primary Completion
2021-12-27
Completion
2021-12-28

Countries

  • Japan

Study Locations

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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 NCT02675491 on ClinicalTrials.gov