Advanced Solid Malignant TumorsPhase 1NCT02690337
Study of DS-1123a in Advanced Solid Tumours
A Phase 1 study testing DS-1123 in people with Advanced Solid Malignant Tumors, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors. 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-1123
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2016to Nov 2017
- 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 tumor that is refractory to standard treatment, or for which no standard treatment is available.
- Eastern Cooperative Oncology Group performance status (PS) of 0 or 1.
Who cannot join
- Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:
- Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia),
- Severe or uncontrolled concomitant disease.
- Clinically active brain metastases defined as symptomatic or requiring treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors
This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.
- Conditions
- Advanced Solid Malignant Tumors
- Being tested
- DS-1123
- Keywords
- Advanced solid malignant tumors, phase 1, oncology, refractory, no standard treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-1123Drug
starting intravenous (IV) dose of 0.1 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| DS-1123 | Experimental | This study will follow a modified Continual Reassessment Method (mCRM) + Escalation with Overdose Control (EWOC),design with a starting intravenous (IV) dose of 0.1 mg/kg. Receives: Drug: DS-1123 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measured: Cycles 1, 2 : Days 1,2, 4, 8, 15
Number and severity of treatment emergent adverse events (TEAEs)
Measured: Day 1 to Day 31
Time of maximum concentration (Tmax)
Measured: Cycles 1, 2: Days 1,2, 4, 8, 15
Elimination rate constant (Kel)
Measured: Cycles 1, 2: Days 1,2, 4, 8, 15
area under the curve AUClast
pharmacokinetics profile
Measured: Cycles 1, 2: Days 1,2, 4, 8, 15
Area under the curve (AUCtau)
Measured: Cycles 1, 2: Days 1,2, 4, 8, 15
Area under the curve (AUCinf)
Measured: Cycles 1, 2: Days 1,2, 4, 8, 15
Half-life (T1/2)
Measured: Cycles 1, 2: Days 1,2, 4, 8, 15
Drug clearance (CL)
Measured: Cycles 1, 2: Days 1,2, 4, 8, 15
Volume of distribution (Vz)
Measured: Cycles 1, 2: Days 1,2, 4, 8, 15
Mean residence time (MRTinf)
Measured: Cycles 1, 2: Days 1,2, 4, 8, 15
Secondary outcomes (2)
DS-1123a antibody
DS-1123a antibody on Cycle 1: Days 1,15; Cycles 2 and on: Day 1, Stop date, final follow-up date
Measured: Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date
Change in Cytokines expression
Change in DS-1123a biomarkers Cytokines expression on Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2
Measured: Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2017
- Study completionNov 2017
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
- 27 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
- NCT02690337
- Sponsor's protocol ID
- DS1123-A-J101
- Status last verified
- Jan 2018
- First submitted
- 4 Feb 2016
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- 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 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02690337
- Acronym / sponsor ID
- DS1123-A-J101
- Conditions
- Advanced Solid Malignant Tumors
- Keywords
- Advanced solid malignant tumors, phase 1, oncology, refractory, no standard treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 24 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 an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS-1123 | Experimental | Drug: DS-1123This study will follow a modified Continual Reassessment Method (mCRM) + Escalation with Overdose Control (EWOC),design with a starting intravenous (IV) dose of 0.1 mg/kg. |
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 tumor that is refractory to standard treatment, or for which no standard treatment is available.
- Eastern Cooperative Oncology Group performance status (PS) of 0 or 1.
Key exclusion criteria (4 listed)
- Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:
- Severe or uncontrolled concomitant disease.
- Clinically active brain metastases defined as symptomatic or requiring 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-1123starting intravenous (IV) dose of 0.1 mg/kg. | Drug | DS-1123 |
Primary outcome
Maximum concentration (Cmax)
Time frame: Cycles 1, 2 : Days 1,2, 4, 8, 15
Number and severity of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 31
Time of maximum concentration (Tmax)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Elimination rate constant (Kel)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
area under the curve AUClast
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
pharmacokinetics profile
Area under the curve (AUCtau)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Area under the curve (AUCinf)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Half-life (T1/2)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Drug clearance (CL)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Volume of distribution (Vz)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Mean residence time (MRTinf)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
2 secondary outcomes
DS-1123a antibody
Time frame: Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date
Change in Cytokines expression
Time frame: Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2
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 24 Dec 2018.
- 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
1 site 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-1123 in people with Advanced Solid Malignant Tumors, run by Daiichi Sankyo Co., Ltd. at 1 site 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 4 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 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Maximum concentration (Cmax) (time frame: Cycles 1, 2 : Days 1,2, 4, 8, 15). The study lists 11 primary outcomes in all. 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 24 Dec 2018.