Malignant Pleural MesotheliomaPhase 1/2NCT03177668
Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
A Phase 1/2 study testing YS110 in people with Malignant Pleural Mesothelioma, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110 intravenous administration in patients with malignant pleural mesothelioma and to preliminarily examine the anti-tumor effect of YS110. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- YS110
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 8 Aug 2017to 5 Feb 2020
- Phase
- Phase 1/2
- 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
- Patient with male or female aged ≥ 20 (and aged < 75 in Phase 1 part)
- Patients whose malignant pleural mesothelioma was histologically confirmed
- Patients who have advanced pleural mesothelioma that are refractory to existing anti-tumor drugs and who have no other standard therapies which should be prioritized
- Patients whose most recent major surgery (except exploratory thoracotomy or laparotomy) or drug or radiation therapy for malignant tumors, if any, was at least 4 weeks ago (at least 12 weeks ago for immunotherapy) at the subject enrollment
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 or less
Who cannot join
- Patients whose toxicity findings in the previous treatment (antineoplastic agents) have not been yet restored
- Patients with tumor lesions in central nervous system confirmed in MRI or CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110 intravenous administration in patients with malignant pleural mesothelioma and to preliminarily examine the anti-tumor effect of YS110.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- YS110
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YS110Drug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| YS110 | Experimental | Phase 1 part: Administration of 3 different dose cohort
Phase 2 part: Administration of recommended dose determined from result of Phase 1 part Receives: Drug: YS110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of onset of Dose Limiting Toxicity (DLT)
Assessed by number of subjects with DLT of YS110
Measured: 18 days
Disease Control Rate (DCR)
The proportion of subjects with assessed overall response as Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Measured: 6 months
Progression Free Survival (PFS)
The period from the starting day of the administration to Progressive Disease (PD) or death
Measured: Assessed for duration of study participation which is estimated to be 18 months
Response Rate (RR)
The proportion of subjects with assessed the best overall response as CR or PR
Measured: Assessed for duration of study participation which is estimated to be 18 months
Overall Survival (OS)
The period from the starting day of the administration to death
Measured: Assessed for duration of study participation which is estimated to be 18 months
LCSS-Meso
Assessed for Quality of life (QOL) by using the modified Lung Cancer Symptom Scale for mesothelioma
Measured: Assessed for duration of study participation which is estimated to be 18 months
EORTC QLQ-C30
Assessed for QOL by using the Japanese versions of EORTC QLQ-C30 in the cancer patients
Measured: Assessed for duration of study participation which is estimated to be 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start8 Aug 2017
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuo Kanai, Study director, Kissei Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177668
- Sponsor's protocol ID
- YS1101
- Status last verified
- Sep 2020
- First submitted
- 23 May 2017
- Last updated
- 25 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT03177668
- Acronym / sponsor ID
- YS1101
- Conditions
- Malignant Pleural Mesothelioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 6 Jun 2017 (actual)
- 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.
The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110 intravenous administration in patients with malignant pleural mesothelioma and to preliminarily examine the anti-tumor effect of YS110.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YS110 | Experimental | Drug: YS110Phase 1 part: Administration of 3 different dose cohort Phase 2 part: Administration of recommended dose determined from result of Phase 1 part |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with male or female aged ≥ 20 (and aged < 75 in Phase 1 part)
- Patients whose malignant pleural mesothelioma was histologically confirmed
- Patients who have advanced pleural mesothelioma that are refractory to existing anti-tumor drugs and who have no other standard therapies which should be prioritized
- Patients whose most recent major surgery (except exploratory thoracotomy or laparotomy) or drug or radiation therapy for malignant tumors, if any, was at least 4 weeks ago (at least 12 weeks ago for immunotherapy) at the subject enrollment
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 or less
Key exclusion criteria (2 listed)
- Patients whose toxicity findings in the previous treatment (antineoplastic agents) have not been yet restored
- Patients with tumor lesions in central nervous system confirmed in MRI or CT
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 |
|---|---|---|
| YS110Intravenous administration | Drug | YS110 |
Primary outcome
Status of onset of Dose Limiting Toxicity (DLT)
Time frame: 18 days
Assessed by number of subjects with DLT of YS110
Disease Control Rate (DCR)
Time frame: 6 months
The proportion of subjects with assessed overall response as Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Progression Free Survival (PFS)
Time frame: Assessed for duration of study participation which is estimated to be 18 months
The period from the starting day of the administration to Progressive Disease (PD) or death
Response Rate (RR)
Time frame: Assessed for duration of study participation which is estimated to be 18 months
The proportion of subjects with assessed the best overall response as CR or PR
Overall Survival (OS)
Time frame: Assessed for duration of study participation which is estimated to be 18 months
The period from the starting day of the administration to death
LCSS-Meso
Time frame: Assessed for duration of study participation which is estimated to be 18 months
Assessed for Quality of life (QOL) by using the modified Lung Cancer Symptom Scale for mesothelioma
EORTC QLQ-C30
Time frame: Assessed for duration of study participation which is estimated to be 18 months
Assessed for QOL by using the Japanese versions of EORTC QLQ-C30 in the cancer patients
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 25 Sep 2020.
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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.
Nobuo Kanai study director
Kissei Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YS110 in people with Malignant Pleural Mesothelioma, run by Kissei Pharmaceutical 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 5 inclusion and 2 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 25 Sep 2020. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Status of onset of Dose Limiting Toxicity (DLT) (time frame: 18 days). The study lists 7 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 25 Sep 2020.