NCT02675491

CompletedPhase 1

Phase 1 Study of DS-6051b in Japanese Subjects With Advanced...

Daiichi Sankyo Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

DS6051-A-J102

Secondary identifiers

153111

REGISTRY · JAPIC CTI

Study Type

interventional

Actual enrollment (reported)

15

Locations

1 country

Sites

3

Timeline

Study Start

February 10, 2016

Actual (reported)

Primary Completion

December 27, 2021

Actual (reported)

Study Completion

December 28, 2021

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 15 participants
Study completion date: December 28, 2021
Actual (reported)
Listed locations: 1 countries · 3 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 2, 2016
Actual (reported)
First Posted
February 5, 2016
Actual (reported)
Study Start
February 10, 2016
Actual (reported)
Primary Completion
December 27, 2021
Actual (reported)
Study Completion
December 28, 2021
Actual (reported)

Last Updated: December 16, 2024
Status Verified: December 2024
Last Update Submitted: December 11, 2024

Conditions

Advanced Solid Malignant Tumors

Keywords

Advanced solid tumorDS-6051bROS1NTRKrefractory to standard therapyno standard therapy

Outcome Measures

Primary Outcomes (1)

number and severity of adverse events
number and severity of treatment emergent adverse events
Day 1 through 28 days after last dose

Secondary Outcomes (5)

Cmax of DS-6051a
Days 1 and 15 of Cycle 1
Tmax of DS-6051a
Days 1 and 15 of Cycle 1
AUC of DS-6051a
Days 1 and 15 of Cycle 1
clearance (CL/F) of DS-6051a
Days 1 and 15 of Cycle 1
Number of participants with dose-limiting toxicities
21 days following the first dose of treatment

Study Arms (1)

DS-6051b

EXPERIMENTAL

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

Drug: DS-6051b

Interventions

DS-6051bDrug

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

DS-6051b

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available.
An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

You may not qualify if:

Sponsors & Collaborators

Daiichi Sankyo Co., Ltd.
Industrylead

Study Sites (3)

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Kinki University Hospital

Osaka, Japan

National Cancer Center Hospital

Tokyo, Japan

Study Officials

Global Clinical Leader
Daiichi Sankyo
STUDY DIRECTOR

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 5, 2016

Study Start

February 10, 2016

Actual (reported)

NCT01290471

Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors

Phase 1Completed

Previously had or currently has any of the following diseases:
Cardiac failure (NYHA Functional Classification ≥ Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment.
Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia).
Severe or uncontrolled concomitant disease.
Clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.

Contact the study team to confirm eligibility.

Primary Completion

December 27, 2021

Actual (reported)

Study Completion

December 28, 2021

Actual (reported)

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02675491
Data provider: ClinicalTrials.gov
Source updated: 2024-12-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:51 UTC

Locations

JP(3)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

DS-6051b

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations