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NCT Number: NCT02675491

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

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.

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Key information

Conditions

Advanced Solid Malignant Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DS-6051b

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2016
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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