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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02675491
Recruitment Status : Active, not recruiting
First Posted : February 5, 2016
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Malignant Tumors Drug: DS-6051b Phase 1

Detailed Description:
This study is single arm study with DS-6051b in approximately 9 subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene. Safety and tolerability, pharmacokinetics (PK), maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) and preliminary efficacy of DS-6051b will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene
Study Start Date : February 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: DS-6051b
Drug: DS-6051b 400 mg or 800 mg daily
Drug: DS-6051b
Drug: DS-6051b 400 mg or 800 mg daily




Primary Outcome Measures :
  1. number and severity of adverse events [ Time Frame: Day 1 through 28 days after last dose ]
    number and severity of treatment emergent adverse events


Secondary Outcome Measures :
  1. Cmax of DS-6051a [ Time Frame: Days 1 and 15 of Cycle 1 ]
    Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1.

  2. Tmax of DS-6051a [ Time Frame: Days 1 and 15 of Cycle 1 ]
    Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1.

  3. AUC of DS-6051a [ Time Frame: Days 1 and 15 of Cycle 1 ]
    Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1.

  4. clearance (CL/F) of DS-6051a [ Time Frame: Days 1 and 15 of Cycle 1 ]
    Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1.

  5. Number of participants with dose-limiting toxicities [ Time Frame: 21 days following the first dose of treatment ]
    to determine maximum tolerated dose/recommended phase 2 dose



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675491


Locations
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Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Kinki University Hospital
Osaka, Japan
National Cancer Center Hospital
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02675491    
Other Study ID Numbers: DS6051-A-J102
153111 ( Registry Identifier: JAPIC CTI )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Advanced solid tumor
DS-6051b
ROS1
NTRK
refractory to standard therapy
no standard therapy
Additional relevant MeSH terms:
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Neoplasms