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

NCT02675491 | Completed Phase 1

• 2 other identifiers: DS6051-A-J102153111
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Malignant Tumors

Keywords

Advanced solid tumor; DS-6051b; ROS1; NTRK; refractory to standard therapy; no 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-6051b DRUG

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

DS-6051b

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (3)

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Location

Kinki University Hospital

Osaka, Japan

Location

National Cancer Center Hospital

Tokyo, Japan

Location

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

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
• Primary Completion: December 27, 2021
• Study Completion: December 28, 2021
• 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.

Locations

JP (3)