Tenosynovial Giant Cell TumorPhase 2NCT04703322

A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan

A Phase 2 study testing Pexidartinib in people with Tenosynovial Giant Cell Tumor, run by Daiichi Sankyo Co., Ltd. at 6 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 phase 2, multicenter, two-part, open-label, single-arm study will be conducted in Japan and will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of pexidartinib in adult participants with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Tenosynovial Giant Cell Tumor
What is being tested?: Pexidartinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 6 sitesJapan
Study dates: 15 Mar 2021to 15 May 2026
Phase: Phase 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

Age ≥20 years
A diagnosis of TGCT (i) that has been histologically confirmed by a pathologist1 and (ii) associated with severe morbidity or functional limitations and not amenable to improvement with surgery determined consensually by qualified personnel (eg, 2 surgeons or a multi-disciplinary tumor board).
Measurable disease as defined by RECIST version 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scan by a central radiologist.

Who cannot join

Known metastatic TGCT.
Pre-existing increased serum transaminases; total bilirubin or direct bilirubin (>upper limit of normal); or active liver or biliary tract disease, including increased alkaline phosphatase.
Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator's opinion, would likely interfere with a participant's study participation or the interpretation of his or her results.
Use of strong cytochrome P450 3A inducers, including St John's wort, proton pump inhibitors and potassium-competitive acid blockers, or other products known to cause hepatotoxicity.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

Nagoya University Hospital
Aichi, 466-8560
Kyushu University Hospital
Fukuoka, 812-8582
Kanazawa University Hospital
Ishikawa, 920-8641
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
Osaka International Cancer Institute
Osaka, 541-8567
National Cancer Center Hospital
Tokyo, 104-0045

Other trials in Japan

About this study

Official title: A Phase 2, Multicenter, Two-Part, Open-Label Study of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor in Japan

Read the detailed description

This study will consist of 2 parts. In Part 1, pexidartinib 800 mg/day (400 mg twice a day [BID]) will be administered on an empty stomach and tolerability and PK of pexidartinib will be evaluated to determine the initiation of Part 2. In Part 2, pexidartinib 800 mg/day (400 mg BID) will be administered on an empty stomach and efficacy, safety, and PK of pexidartinib will be evaluated.

Conditions: Tenosynovial Giant Cell Tumor
Being tested: Pexidartinib
Keywords: Tenosynovial Giant Cell Tumor, TGCT, Giant Cell Tumor of Tendon Sheath, GCTTS, Pigmented Villonodular Synovitis, PVNS
Medical subject headings: Giant Cell Tumor of Tendon Sheath, Synovitis, Pigmented Villonodular

What participants receive

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

PexidartinibDrug
Also called TURALIO™, PLX3397
400 mg twice daily for a total daily dose of 800 mg (each capsule contains 200 mg of pexidartinib for oral administration)

Study groups in NCT04703322
Study group	Role	What they receive
Pexidartinib	Experimental	Participants with TGCT who will receive oral pexidartinib 800 mg (400 mg twice daily [BID]). Receives: Drug: Pexidartinib

What is being measured

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

Dose-limiting Toxicity (DLT) in Part 1
The number of participants with any-grade DLT treatment-emergent adverse events (TEAEs) were assessed.
Measured: Cycle 1, Day 1 to Cycle 1, Day 28 (each cycle is 28 days)
Pharmacokinetic Parameter Maximum Concentration of Pexidartinib and ZAAD-1006a (Cmax) in Part 1
Pharmacokinetic parameters were assessed using non-compartmental methods. Cmax is the maximum concentration of pexidartinib and ZAAD-1006a in plasma.
Measured: Predose, 0.5 hours (hr), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hr post-dose of Cycle 1, Day 1 (C1D1) and Predose, 0.5 hr, 1 hr, 2 hr, 4 hr, and 6 hr postdose of Cycle 1, Day 15 (C1D15) (each cycle is 28 days)
Pharmacokinetic Parameter Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration of Pexidartinib and ZAAD-1006a (AUClast) in Part 1
Pharmacokinetic parameters were assessed using non-compartmental methods. AUClast is the area under the concentration-time curve from time zero to time of last measurable concentration of pexidartinib and ZAAD-1006a in plasma.
Measured: Predose, 0.5 hours (hr), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hrs post-dose of Cycle 1, Day 1 (C1D1) (each cycle is 28 days)
Pharmacokinetic Parameter Area Under the Concentration-Time Curve Up to Infinity of Pexidartinib and ZAAD-1006a (AUCinf) in Part 1
Pharmacokinetic parameters were assessed using non-compartmental methods. AUCinf is the area under the concentration-time curve up to infinity of pexidartinib and ZAAD-1006a in plasma.
Measured: Predose, 0.5 hours (hr), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hrs post-dose of Cycle 1, Day 1 (C1D1) (each cycle is 28 days)
Pharmacokinetic Parameter Time to Reach Maximum Concentration of Pexidartinib and ZAAD-1006a (Tmax) in Part 1
Pharmacokinetic parameters were assessed using non-compartmental methods. Tmax is the time to reach maximum concentration of pexidartinib and ZAAD-1006a in plasma.
Measured: Predose, 0.5 hours (hr), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hr post-dose of Cycle 1, Day 1 (C1D1) and Predose, 0.5 hr, 1 hr, 2 hr, 4 hr, and 6 hr postdose of Cycle 1, Day 15 (C1D15) (each cycle is 28 days)
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST Version 1.1) in Part 2
ORR will be assessed by centrally reviewed MRI scan based on RECIST version 1.1. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Measured: Week 25

Secondary outcomes (9)

ORR Based on Tumor Volume Score (TVS) in Part 2
ORR will be assessed by centrally reviewed MRI scan based on TVS.
Measured: Week 25
Range of Motion (ROM) in Part 2
Mean change from baseline in ROM of the affected joint, relative to a reference standard for the same joint will be assessed.
Measured: Week 25
Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Scale in Part 2
Mean change from baseline score in the PROMIS Physical Function Scale will be assessed.
Measured: Week 25
Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale (NRS) in Part 2
Proportion of responders will be assessed based on the BPI Worst Pain NRS item and analgesic use by BPI-30 definition (ie, 30% or more improvement in average NRS).
Measured: Week 25
Best Overall Response (BOR) Based on RECIST Version 1.1 in Part 2
BOR will be assessed by centrally reviewed magnetic resonance imaging (MRI) scan based on RECIST version 1.1.
Measured: Post Week 25 visit or following discontinuation from Part 2 of the study (whichever occurs first), up to approximately 1 year 6 months
BOR Based on TVS in Part 2
BOR will be assessed by centrally reviewed MRI scan based on TVS.
Measured: Post Week 25 visit or following discontinuation from Part 2 of the study (whichever occurs first), up to approximately 1 year 6 months
Duration of Response (DoR) Based on RECIST Version 1.1 in Part 2
DoR will be assessed by centrally reviewed MRI scan based on RECIST version 1.1.
Measured: Post Week 25 visit or following discontinuation from Part 2 of the study (whichever occurs first), up to approximately 1 year 6 months
DoR Based on TVS
DoR will be assessed by centrally reviewed MRI scan based on TVS.
Measured: Post Week 25 visit or following discontinuation from Part 2 of the study (whichever occurs first), up to approximately 1 year 6 months
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events
Measured: Baseline up to 28 (+/- 7 days) after last dose, up to approximately 6 years 9 months

Timeline

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

15 Mar 202115 May 2026

First posted11 Jan 2021
Study start15 Mar 2021
Primary completion20 Mar 2023
Study completion15 May 2026

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 Tenosynovial Giant Cell TumorStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04703322
Sponsor's protocol ID: PL3397-A-J304
Other IDs: jRCT2041200074
Status last verified: May 2026
First submitted: 22 Dec 2020
Last updated: 24 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

Recruiting
Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis
Synovitis Villonodular
RecruitingPhase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
Neurofibroma, Plexiform, Precursor Cell Lymphoblastic Leukemia-Lymphoma
RecruitingPhase 2
Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)
Tenosynovial Giant Cell Tumor
Not yet recruitingPhase 2
A Study of DCC-3014 to Evaluate the Efficacy, Safety, and Pharmacokinetics in Subjects With TGCT
Tenosynovial Giant Cell Tumor
RecruitingPhase 1/2
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
Adipocytic Neoplasm, Liposarcoma

All Tenosynovial Giant Cell Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Two-Part, Open-Label Study of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor in Japan
ClinicalTrials.gov ID: NCT04703322
Acronym / sponsor ID: PL3397-A-J304
Conditions: Tenosynovial Giant Cell Tumor
Keywords: Tenosynovial Giant Cell Tumor, TGCT, Giant Cell Tumor of Tendon Sheath, GCTTS, Pigmented Villonodular Synovitis, PVNS
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Study start: 15 Mar 2021 (actual)
Primary completion: 20 Mar 2023 (actual)
Study completion: 15 May 2026 (actual)
First posted: 11 Jan 2021 (actual)
Results: Posted 3 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

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

Arm	Type	Receives
Pexidartinib	Experimental	Drug: PexidartinibParticipants with TGCT who will receive oral pexidartinib 800 mg (400 mg twice daily [BID]).

Who may qualify

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

Key inclusion criteria (3 listed)

Age ≥20 years
A diagnosis of TGCT (i) that has been histologically confirmed by a pathologist1 and (ii) associated with severe morbidity or functional limitations and not amenable to improvement with surgery determined consensually by qualified personnel (eg, 2 surgeons or a multi-disciplinary tumor board).
Measurable disease as defined by RECIST version 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scan by a central radiologist.

Key exclusion criteria (4 listed)

Known metastatic TGCT.
Pre-existing increased serum transaminases; total bilirubin or direct bilirubin (>upper limit of normal); or active liver or biliary tract disease, including increased alkaline phosphatase.
Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator's opinion, would likely interfere with a participant's study participation or the interpretation of his or her results.
Use of strong cytochrome P450 3A inducers, including St John's wort, proton pump inhibitors and potassium-competitive acid blockers, or other products known to cause hepatotoxicity.

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
PexidartinibAlso: TURALIO™, PLX3397400 mg twice daily for a total daily dose of 800 mg (each capsule contains 200 mg of pexidartinib for oral administration)	Drug	Pexidartinib

Primary outcome

Dose-limiting Toxicity (DLT) in Part 1
Time frame: Cycle 1, Day 1 to Cycle 1, Day 28 (each cycle is 28 days)
The number of participants with any-grade DLT treatment-emergent adverse events (TEAEs) were assessed.
Pharmacokinetic Parameter Maximum Concentration of Pexidartinib and ZAAD-1006a (Cmax) in Part 1
Time frame: Predose, 0.5 hours (hr), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hr post-dose of Cycle 1, Day 1 (C1D1) and Predose, 0.5 hr, 1 hr, 2 hr, 4 hr, and 6 hr postdose of Cycle 1, Day 15 (C1D15) (each cycle is 28 days)
Pharmacokinetic parameters were assessed using non-compartmental methods. Cmax is the maximum concentration of pexidartinib and ZAAD-1006a in plasma.
Pharmacokinetic Parameter Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration of Pexidartinib and ZAAD-1006a (AUClast) in Part 1
Time frame: Predose, 0.5 hours (hr), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hrs post-dose of Cycle 1, Day 1 (C1D1) (each cycle is 28 days)
Pharmacokinetic parameters were assessed using non-compartmental methods. AUClast is the area under the concentration-time curve from time zero to time of last measurable concentration of pexidartinib and ZAAD-1006a in plasma.
Pharmacokinetic Parameter Area Under the Concentration-Time Curve Up to Infinity of Pexidartinib and ZAAD-1006a (AUCinf) in Part 1
Time frame: Predose, 0.5 hours (hr), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hrs post-dose of Cycle 1, Day 1 (C1D1) (each cycle is 28 days)
Pharmacokinetic parameters were assessed using non-compartmental methods. AUCinf is the area under the concentration-time curve up to infinity of pexidartinib and ZAAD-1006a in plasma.
Pharmacokinetic Parameter Time to Reach Maximum Concentration of Pexidartinib and ZAAD-1006a (Tmax) in Part 1
Time frame: Predose, 0.5 hours (hr), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hr post-dose of Cycle 1, Day 1 (C1D1) and Predose, 0.5 hr, 1 hr, 2 hr, 4 hr, and 6 hr postdose of Cycle 1, Day 15 (C1D15) (each cycle is 28 days)
Pharmacokinetic parameters were assessed using non-compartmental methods. Tmax is the time to reach maximum concentration of pexidartinib and ZAAD-1006a in plasma.
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST Version 1.1) in Part 2
Time frame: Week 25
ORR will be assessed by centrally reviewed MRI scan based on RECIST version 1.1. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

9 secondary outcomes

ORR Based on Tumor Volume Score (TVS) in Part 2
Time frame: Week 25
Range of Motion (ROM) in Part 2
Time frame: Week 25
Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Scale in Part 2
Time frame: Week 25
Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale (NRS) in Part 2
Time frame: Week 25
Best Overall Response (BOR) Based on RECIST Version 1.1 in Part 2
Time frame: Post Week 25 visit or following discontinuation from Part 2 of the study (whichever occurs first), up to approximately 1 year 6 months
BOR Based on TVS in Part 2
Time frame: Post Week 25 visit or following discontinuation from Part 2 of the study (whichever occurs first), up to approximately 1 year 6 months
Duration of Response (DoR) Based on RECIST Version 1.1 in Part 2
Time frame: Post Week 25 visit or following discontinuation from Part 2 of the study (whichever occurs first), up to approximately 1 year 6 months
DoR Based on TVS
Time frame: Post Week 25 visit or following discontinuation from Part 2 of the study (whichever occurs first), up to approximately 1 year 6 months
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events
Time frame: Baseline up to 28 (+/- 7 days) after last dose, up to approximately 6 years 9 months

Results and safety

Results posted to the registry on 3 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pexidartinib	9	0

Primary outcome: Dose-limiting Toxicity (DLT) in Part 1

Time frame: Cycle 1, Day 1 to Cycle 1, Day 28 (each cycle is 28 days). Count of participants. Unit: Participants

Measure	Pexidartinib n = 9
Any Grade DLT TEAE	2
Any Grade Hepatic function abnormal	1
Any Grade Alanine aminotransferase increased	1
Any Grade Aspartate aminotransferase increased	1
Any Grade Blood alkaline phosphatase increased	1
Any Grade Gamma-glutamyltransferase increased	1

Population analysed: All DLT TEAEs were assessed in the DLT Evaluable Set.

Primary outcome: Pharmacokinetic Parameter Maximum Concentration of Pexidartinib and ZAAD-1006a (Cmax) in Part 1

Time frame: Predose, 0.5 hours (hr), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hr post-dose of Cycle 1, Day 1 (C1D1) and Predose, 0.5 hr, 1 hr, 2 hr, 4 hr, and 6 hr postdose of Cycle 1, Day 15 (C1D15) (each cycle is 28 days). Mean (Standard Deviation). Unit: ng/mL

Measure	Pexidartinib n = 9
Pexidartinib, C1D1	7920 (1720)
Pexidartinib, C1D15	8810 (1110)
ZAAD-1006a, C1D1	8000 (1990)
ZAAD-1006a, C1D15	11700 (3340)

Population analysed: Pharmacokinetic data were assessed in the Pharmacokinetic Analysis Set.

Primary outcome: Pharmacokinetic Parameter Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration of Pexidartinib and ZAAD-1006a (AUClast) in Part 1

Time frame: Predose, 0.5 hours (hr), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hrs post-dose of Cycle 1, Day 1 (C1D1) (each cycle is 28 days). Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Pexidartinib n = 9
Pexidartinib, C1D1	62000 (27.3)
ZAAD-1006a, C1D1	90900 (48.4)

Population analysed: Pharmacokinetic data were assessed in the Pharmacokinetic Analysis Set.

Primary outcome: Pharmacokinetic Parameter Area Under the Concentration-Time Curve Up to Infinity of Pexidartinib and ZAAD-1006a (AUCinf) in Part 1

Measure	Pexidartinib n = 9
Pexidartinib, C1D1	8700 (28.1)
ZAAD-1006a, C1D1	195000 (40.2)

Population analysed: Pharmacokinetic data were assessed in participants with available data in the Pharmacokinetic Analysis Set.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from screening to 28 days (+/-7 days) after last dose of study treatment, up to 3 years 7 months (data cut-off date).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pexidartinib	0 of 9 (0%)	9 of 9 (100%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Tenosynovial Giant Cell Tumor

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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

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pexidartinib in people with Tenosynovial Giant Cell Tumor, run by Daiichi Sankyo Co., Ltd. at 6 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 3 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 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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 3 Mar 2025). 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?

Dose-limiting Toxicity (DLT) in Part 1 (time frame: Cycle 1, Day 1 to Cycle 1, Day 28 (each cycle is 28 days)). The study lists 6 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 NCT04703322.

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 Jun 2026.