Malignant Pleural MesotheliomaPhase 1/2NCT02347917

A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma

A Phase 1/2 study testing BBI608, Pemetrexed and Cisplatin in people with Malignant Pleural Mesothelioma and Non-Small Cell Lung Cancer, run by Sumitomo Pharma Co., Ltd. at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label, multicenter, phase 1/2 study of BBI608 in combination with pemetrexed and cisplatin chemotherapy as a 1st line treatment for Malignant Pleural Mesothelioma (MPM). Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer
What is being tested?: BBI608, Pemetrexed and Cisplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 2 sitesJapan
Study dates: Feb 2015to 31 May 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Histologically confirmed diagnosis of Malignant Pleural Mesothelioma (MPM) or Non-Small Cell Lung Cancer (NSCLC).
Measurable disease as defined by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) for MPM or the RECIST 1.1 for NSCLC.
≥ 20 years of age.
Provision of written informed consent.
For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

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Hemoglobin (Hb) ≥ 9.0 g/dL.
Neutrophils ≥ 1500/μL.
Platelets ≥ 100,000/μL.
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5-fold the upper limit of normal range (ULN) [≤ 5-fold ULN with any liver metastasis].
Total bilirubin ≤ 1.5-fold ULN.
Creatinine clearance (estimated value) ≥ 60 mL/min.
Life expectancy ≥ 3 months.
Females of childbearing potential have a negative urine pregnancy test.
Phase 2
Histologically confirmed diagnosis of MPM.
Treatment naïve and not indicated for resection.
Measurable disease as defined by the modified RECIST.
≥ 20 years of age.
Provision of written informed consent.
For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose.
ECOG Performance Status of 0 or 1.
Hb ≥ 9.0 g/dL.
Neutrophils ≥ 1500/μL.
Platelets ≥ 100,000/μL.
AST and ALT ≤ 2.5-fold ULN [≤ 5-fold ULN for patients with any liver metastasis].
Total bilirubin ≤ 1.5-fold ULN.
Creatinine clearance (estimated value) > 60 mL/min.
Life expectancy ≥ 3 months.
Females of childbearing potential have a negative urine pregnancy test.
Both Phase 1 and 2

Who cannot join

Prior anti-cancer chemotherapy and radiotherapy.
Prior hormonal therapy, immunotherapy, thermotherapy, operation.
Any brain metastasis requiring treatment or symptomatic.
Active multiple primary cancers.
Crohn's disease, ulcerative colitis, small intestine resection.
Abnormal ECGs.

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Prior myocardial infarction.
Current use of antiarrhythmic medication.
Uncontrolled concurrent diseases.
Known severe hypersensitivity to pemetrexed, cisplatin or other drugs containing platinum.
Women who are pregnant or breastfeeding.
Received other investigational drugs.
Unable or unwilling to swallow BBI608 capsules daily.
Prior treatment with BBI608.
Ineligible for participation in the study in the opinion of the Investigators.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

National Cancer Center Hospital East
Chiba
National Cancer Center Hospital
Tokyo

Other trials in Japan

About this study

Official title: A Phase I/II Clinical Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma

This is an open-label, multicenter, phase 1/2 study of BBI608 in combination with pemetrexed and cisplatin chemotherapy as a 1st line treatment for Malignant Pleural Mesothelioma (MPM).

Conditions: Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer
Being tested: BBI608, Pemetrexed, Cisplatin
Medical subject headings: Mesothelioma, Malignant, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BBI608Drug
480 mg orally twice daily (960 mg total daily dose)
PemetrexedDrug
500 mg/m2 I.V. infusion on Day 1 of each treatment cycle (except for cycle 1, in which Pemetrexed will be given on Day 3).
CisplatinDrug
75 mg/m2 I.V. infusion on Day 1 of each treatment cycle (except for Cycle 1, in which Cisplatin will be given on Day 3).

Study groups in NCT02347917
Study group	Role	What they receive
BBI608 puls pemetrexed and cisplatin	Experimental	Not described Receives: Drug: BBI608; Drug: Pemetrexed; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1 Part: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs)
An AE is any untoward medical occurrence in a study subject administered an investigational drug and which does not necessarily have a causal relationship with this treatment.
A SAE was an AE that met one or more of the following criteria:
- Results in death
- Is life-threatening
- Requires hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability or incapacity
- Is a congenital anomaly or birth defect
- Is an important medical event that may jeopardize the subject or may require a medical or surgical intervention to prevent one of the outcomes listed above. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization.
An ADR was defined as adverse events assessed to be related to the investigational drug
Measured: Between initial dosing of the investigational drug and final evaluation in the follow-up observation period, about 17 months
Phase 1 Part: Number of Participants With Dose-limiting Toxicities (DLTs)
DLT was defined as an adverse event meeting any of the following that occurred during the DLT evaluation period in any participants given BBI608 with the causal relationship to BBI608 assessed as "Definite," "Probable," or "Possible." The severity of adverse events was graded according to the CTCAE v4.0-JCOG.
- Grade 4 neutropenia persisting for ≥ 7 days
- Grade ≥ 3 febrile neutropenia persisting for ≥ 5 days
- Grade 3 thrombocytopenia requiring platelet transfusions, grade 4 thrombocytopenia
- Grade ≥ 3 non-hematotoxicity except the following:
1. Inappetence, nausea, vomiting and electrolyte abnormality which, within 3 days of onset, improved to grade ≤ 2 or resolved after appropriate treatment
2. Diarrhoea and fatigue which, within 5 days of onset, improved to grade ≤ 2 or resolved after appropriate treatment
- Other clinically significant signs in the opinion of the investigator
Measured: From Day 1 of Cycle 1 to Day 24 pre-dose examination (23 days)
Phase 1 Part: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of BBI608 When Administered With Pem and CDDP
Measured: Cycle 1 Day 1 (Cmax only) and Day 23
Phase 1 Part: Area Under the Concentration-time Curve
AUC0-12: Area under the concentration-time curve from time zero to 12 hours, AUC0-24: Area under the concentration-time curve from time zero to 24 hours, AUC0-inf: Area under the concentration-time curve from time zero to infinity
Measured: Cycle 1 Day 1 and Day 23
Phase 2 Part: Progression-free Survival (PFS)
PFS was defined as the time from BBI608 administration to documented PD (as assessed according to the mRECIST or RECIST 1.1) or death, whichever is earlier. The result of imaging assessment by the imaging assessment committee was used for phase 2 part.
Measured: From BBI608 administration to documented PD or death, whichever is earlier, about 17 months

Secondary outcomes (5)

Best Overall Response
The best overall response is the best response recorded from the start of the study treatment until the end of treatment. The RECIST 1.1 was used for the evaluation of tumor response and overall response in patients with NSCLC, and also the evaluation of any non-pleural lesions in patients with MPM. The mRECIST was used for the evaluation of tumor response and overall response in patients with MPM. The result of imaging assessment by study site was used for phase 1 part, and the result of imaging assessment by the imaging assessment committee was used for phase 2 part.
Measured: Every 6 weeks from the first dose of BBI608 until Week 30, and every 9 weeks from Week 31.
Response Rate (RR) and Disease Control Rate (DCR)
Response rate (RR): Proportion of subjects whose best overall response is CR or PR.
Disease control rate (DCR): Proportion of subjects whose best overall response is CR, PR or SD.
The result of imaging assessment by study site was used for phase 1 part, and the result of imaging assessment by the imaging assessment committee was used for phase 2 part.
Measured: From BBI608 administration to death from any cause, about 17 months
Overall Survival(OS)
OS was defined as the time from BBI608 administration to death from any cause. Participants alive at final observation or lost to follow-up were censored at their last contact (i.e., visit or telephone) date.
Measured: From BBI608 administration to death from any cause, up to 31 months
Respiratory Function Tests (Vital Capacity [VC] and Forced Vital Capacity [FVC])
Measured: Every 6 weeks from the first dose of BBI608 until Week 30, and then every 9 weeks from Week 31 [Actually up to Week 111]
Respiratory Function Tests (Forced Expiratory Volume in the First Second [FEV1])
Measured: Every 6 weeks from the first dose of BBI608 until Week 30, and then every 9 weeks from Week 31 [Actually up to Week 111]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201531 May 2018

First posted28 Jan 2015 (estimated)
Study startFeb 2015
Primary completion31 May 2018
Study completion31 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02347917
Sponsor's protocol ID: D8807005
Status last verified: Apr 2022
First submitted: 21 Jan 2015
Last updated: 12 Apr 2022
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
Active, not recruitingPhase 1
Safety and Preliminary Antitumor Activity of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant

All Malignant Pleural Mesothelioma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Clinical Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma
ClinicalTrials.gov ID: NCT02347917
Acronym / sponsor ID: D8807005
Conditions: Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: Feb 2015 (actual)
Primary completion: 31 May 2018 (actual)
Study completion: 31 May 2018 (actual)
First posted: 28 Jan 2015 (estimated)
Results: Posted 1 Oct 2021

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, multicenter, phase 1/2 study of BBI608 in combination with pemetrexed and cisplatin chemotherapy as a 1st line treatment for Malignant Pleural Mesothelioma (MPM).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BBI608 puls pemetrexed and cisplatin	Experimental	Drug: BBI608, Drug: Pemetrexed, Drug: Cisplatin

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (31 listed)

Histologically confirmed diagnosis of Malignant Pleural Mesothelioma (MPM) or Non-Small Cell Lung Cancer (NSCLC).
Measurable disease as defined by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) for MPM or the RECIST 1.1 for NSCLC.
≥ 20 years of age.
Provision of written informed consent.
For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose.

Key exclusion criteria (15 listed)

Prior anti-cancer chemotherapy and radiotherapy.
Prior hormonal therapy, immunotherapy, thermotherapy, operation.
Any brain metastasis requiring treatment or symptomatic.
Active multiple primary cancers.
Crohn's disease, ulcerative colitis, small intestine resection.

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
BBI608480 mg orally twice daily (960 mg total daily dose)	Drug	BBI608 puls pemetrexed and cisplatin
Pemetrexed500 mg/m2 I.V. infusion on Day 1 of each treatment cycle (except for cycle 1, in which Pemetrexed will be given on Day 3).	Drug	BBI608 puls pemetrexed and cisplatin
Cisplatin75 mg/m2 I.V. infusion on Day 1 of each treatment cycle (except for Cycle 1, in which Cisplatin will be given on Day 3).	Drug	BBI608 puls pemetrexed and cisplatin

Primary outcome

Phase 1 Part: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs)
Time frame: Between initial dosing of the investigational drug and final evaluation in the follow-up observation period, about 17 months
An AE is any untoward medical occurrence in a study subject administered an investigational drug and which does not necessarily have a causal relationship with this treatment. A SAE was an AE that met one or more of the following criteria: * Results in death * Is life-threatening * Requires hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Is a congenital anomaly or birth defect * Is an important medical event that may jeopardize the subject or may require a medical or surgical intervention to prevent one of the outcomes listed above. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization. An ADR was defined as adverse events assessed to be related to the investigational drug
Phase 1 Part: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: From Day 1 of Cycle 1 to Day 24 pre-dose examination (23 days)
DLT was defined as an adverse event meeting any of the following that occurred during the DLT evaluation period in any participants given BBI608 with the causal relationship to BBI608 assessed as "Definite," "Probable," or "Possible." The severity of adverse events was graded according to the CTCAE v4.0-JCOG. * Grade 4 neutropenia persisting for ≥ 7 days * Grade ≥ 3 febrile neutropenia persisting for ≥ 5 days * Grade 3 thrombocytopenia requiring platelet transfusions, grade 4 thrombocytopenia * Grade ≥ 3 non-hematotoxicity except the following: 1. Inappetence, nausea, vomiting and electrolyte abnormality which, within 3 days of onset, improved to grade ≤ 2 or resolved after appropriate treatment 2. Diarrhoea and fatigue which, within 5 days of onset, improved to grade ≤ 2 or resolved after appropriate treatment * Other clinically significant signs in the opinion of the investigator
Phase 1 Part: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of BBI608 When Administered With Pem and CDDP
Time frame: Cycle 1 Day 1 (Cmax only) and Day 23
Phase 1 Part: Area Under the Concentration-time Curve
Time frame: Cycle 1 Day 1 and Day 23
AUC0-12: Area under the concentration-time curve from time zero to 12 hours, AUC0-24: Area under the concentration-time curve from time zero to 24 hours, AUC0-inf: Area under the concentration-time curve from time zero to infinity
Phase 2 Part: Progression-free Survival (PFS)
Time frame: From BBI608 administration to documented PD or death, whichever is earlier, about 17 months
PFS was defined as the time from BBI608 administration to documented PD (as assessed according to the mRECIST or RECIST 1.1) or death, whichever is earlier. The result of imaging assessment by the imaging assessment committee was used for phase 2 part.

5 secondary outcomes

Best Overall Response
Time frame: Every 6 weeks from the first dose of BBI608 until Week 30, and every 9 weeks from Week 31.
Response Rate (RR) and Disease Control Rate (DCR)
Time frame: From BBI608 administration to death from any cause, about 17 months
Overall Survival(OS)
Time frame: From BBI608 administration to death from any cause, up to 31 months
Respiratory Function Tests (Vital Capacity [VC] and Forced Vital Capacity [FVC])
Time frame: Every 6 weeks from the first dose of BBI608 until Week 30, and then every 9 weeks from Week 31 [Actually up to Week 111]
Respiratory Function Tests (Forced Expiratory Volume in the First Second [FEV1])
Time frame: Every 6 weeks from the first dose of BBI608 until Week 30, and then every 9 weeks from Week 31 [Actually up to Week 111]

Results and safety

Results posted to the registry on 1 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	4	4
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	24	23

Primary outcome: Phase 1 Part: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs)

Time frame: Between initial dosing of the investigational drug and final evaluation in the follow-up observation period, about 17 months. Count of participants. Unit: Participants

Measure	MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) n = 4
Any AEs	4
AEs leading to death	0
Serious AEs	0
AEs leading to drug withdrawn (BBI608)	1
AEs leading to drug interrupted (BBI608)	1
AEs leading to dose reduced (BBI608)	0
Any ADRs	4
ADRs leading to death	0

Population analysed: Safety analysis populations (Phase 1 part)

Primary outcome: Phase 1 Part: Number of Participants With Dose-limiting Toxicities (DLTs)

Time frame: From Day 1 of Cycle 1 to Day 24 pre-dose examination (23 days). Count of participants. Unit: Participants

Measure	MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) n = 3
Value	0

Population analysed: DLT evaluable population (3 participants with NSCLC in Phase 1 part) 1 participant with MPM was excluded from DLT evaluable population because the BBI608 treatment compliance rate during DLT evaluation period did not meet the rate of 80% which of assessable for DLT and no adverse events assessed as DLT occurred.

Primary outcome: Phase 1 Part: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of BBI608 When Administered With Pem and CDDP

Time frame: Cycle 1 Day 1 (Cmax only) and Day 23. Mean (Full Range). Unit: ng/mL

Measure	MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) n = 4
Day 1: Cmax	307.5 (251 to 380)
Day 23: Cmax	473.7 (316 to 643)
Day 23: Cmin	196.1 (30.4 to 392.0)

Population analysed: Pharmacokinetic (PK) analysis population 1 participant with MPM of 4 participants in the pharmacokinetic analysis population completed BBI608 administration on Day 14 in Cycle 1 and therefore was not included in the analysis for Cmax and AUC on Day 23.

Primary outcome: Phase 1 Part: Area Under the Concentration-time Curve

Time frame: Cycle 1 Day 1 and Day 23. Mean (Full Range). Unit: h*ng/mL

Measure	MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part) n = 4
Day 1: AUC0-12	1814.3 (900 to 2443)
Day 1: AUC0-24	2223.8 (1005 to 3060)
Day 1: AUC0-inf	2413.5 (1141 to 3536)
Day 23: AUC0-12	3797.0 (1788 to 5725)
Day 23: AUC0-24	6103.7 (1936 to 9948)
Day 23: AUC0-inf	10762.7 (1962 to 20834)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: During a period from initial dosing of investigational drug to final evaluation in the follow-up observation period. up to 31 months for deaths, up to 11 months for Serious and Other (Not Including Serious) Adverse Events. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)	0 of 4 (0%)	4 of 4 (100%)	2 of 4
MPM: BBI608 + Pem + CDDP (Phase 2 Part)	7 of 24 (29.2%)	24 of 24 (100%)	19 of 24
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)	7 of 25 (28%)	25 of 25 (100%)	21 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Sumitomo Pharma Co., Ltd. Japan study director

Sumitomo Pharma Co., Ltd.

2 sites 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 BBI608, Pemetrexed and Cisplatin in people with Malignant Pleural Mesothelioma and Non-Small Cell Lung Cancer, run by Sumitomo Pharma Co., Ltd. at 2 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 31 inclusion and 15 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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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?

Yes. Results are posted in the registry (first posted 1 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase 1 Part: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs) (time frame: Between initial dosing of the investigational drug and final evaluation in the follow-up observation period, about 17 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02347917.

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 12 Apr 2022.