Advanced Solid Malignant TumorsPhase 1NCT02675491
Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors
A Phase 1 study testing DS-6051b in people with Advanced Solid Malignant Tumors, run by Daiichi Sankyo Co., Ltd. at 3 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Malignant Tumors
- What is being tested?
- DS-6051b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesJapan
- Study dates
- 10 Feb 2016to 28 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
National Hospital Organization Kyushu Cancer Center
Fukuoka
Kinki University Hospital
Osaka
National Cancer Center Hospital
Tokyo
About this study
Official title: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene
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.
Read the 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.
- Conditions
- Advanced Solid Malignant Tumors
- Being tested
- DS-6051b
- Keywords
- Advanced solid tumor, DS-6051b, ROS1, NTRK, refractory to standard therapy, no standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-6051bDrug
Drug: DS-6051b 400 mg or 800 mg daily
| Study group | Role | What they receive |
|---|---|---|
| DS-6051b | Experimental | Drug: DS-6051b 400 mg or 800 mg daily Receives: Drug: DS-6051b |
What is being measured
The primary outcome is the main question the study is designed to answer.
number and severity of adverse events
number and severity of treatment emergent adverse events
Measured: Day 1 through 28 days after last dose
Secondary outcomes (5)
Cmax of DS-6051a
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.
Measured: Days 1 and 15 of Cycle 1
Tmax of DS-6051a
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.
Measured: Days 1 and 15 of Cycle 1
AUC of DS-6051a
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.
Measured: Days 1 and 15 of Cycle 1
clearance (CL/F) of DS-6051a
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.
Measured: Days 1 and 15 of Cycle 1
Number of participants with dose-limiting toxicities
to determine maximum tolerated dose/recommended phase 2 dose
Measured: 21 days following the first dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start10 Feb 2016
- Primary completion27 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Malignant TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675491
- Sponsor's protocol ID
- DS6051-A-J102
- Other IDs
- 153111
- Status last verified
- Dec 2024
- First submitted
- 2 Feb 2016
- Last updated
- 16 Dec 2024
- Results posted
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene
- ClinicalTrials.gov ID
- NCT02675491
- Acronym / sponsor ID
- DS6051-A-J102
- Conditions
- Advanced Solid Malignant Tumors
- Keywords
- Advanced solid tumor, DS-6051b, ROS1, NTRK, refractory to standard therapy, no standard therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS-6051b | Experimental | Drug: DS-6051bDrug: DS-6051b 400 mg or 800 mg daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS-6051bDrug: DS-6051b 400 mg or 800 mg daily | Drug | DS-6051b |
Primary outcome
number and severity of adverse events
Time frame: Day 1 through 28 days after last dose
number and severity of treatment emergent adverse events
5 secondary outcomes
Cmax of DS-6051a
Time frame: Days 1 and 15 of Cycle 1
Tmax of DS-6051a
Time frame: Days 1 and 15 of Cycle 1
AUC of DS-6051a
Time frame: Days 1 and 15 of Cycle 1
clearance (CL/F) of DS-6051a
Time frame: Days 1 and 15 of Cycle 1
Number of participants with dose-limiting toxicities
Time frame: 21 days following the first dose of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DS-6051b in people with Advanced Solid Malignant Tumors, run by Daiichi Sankyo Co., Ltd. at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number and severity of adverse events (time frame: Day 1 through 28 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.