Tenosynovial Giant Cell TumorPhase 2NCT07832747
A Study of DCC-3014 to Evaluate the Efficacy, Safety, and Pharmacokinetics in Subjects With TGCT
A Phase 2 study testing DCC-3014 in people with Tenosynovial Giant Cell Tumor, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the efficacy, safety, and pharmacokinetics of DCC-3014 in subjects with Tenosynovial Giant Cell Tumor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tenosynovial Giant Cell Tumor
- What is being tested?
- DCC-3014
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 31 Oct 2026to 31 May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of TGCT (tumor biopsy to confirm diagnosis will be required if no histology/pathology is available at screening), and a TGCT in a single joint that can be assessed for range of motion (ROM)
- TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity
- Participants who have symptoms defined as at least moderate pain or at least moderate stiffness during the screening period
- Other protocol defined inclusion criteria may apply
Who cannot join
- Metastatic TGCT or other active malignancy that requires treatment, or history of malignancy within 5 years prior to initiation of the screening period (excluding non-metastatic squamous cell carcinoma, basal cell carcinoma, or cervix carcinoma in situ with documented cure)
- QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females, or history of long QT syndrome
- Active liver or biliary disease, including nonalcoholic steatohepatitis (NASH) or cirrhosis
- Other protocol defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
About this study
Official title: A Phase 2, Multicenter, Open-label, Non-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DCC-3014 in Japanese Subjects With Tenosynovial Giant Cell Tumor (TGCT)
To evaluate the efficacy, safety, and pharmacokinetics of DCC-3014 in subjects with Tenosynovial Giant Cell Tumor
- Conditions
- Tenosynovial Giant Cell Tumor
- Being tested
- DCC-3014
- Medical subject headings
- Giant Cell Tumor of Tendon Sheath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCC-3014Drug
DCC-3014 will be orally administered at a dose of 30 mg twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| DCC-3014 | Experimental | Not described Receives: Drug: DCC-3014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR at Week 24
Proportion of participants with a response of CR or PR based on independent radiological review, per RECIST v1.1
Measured: at Week 24
Secondary outcomes (13)
Adverse events
To assess the safety of DCC-3014 in Japanese patients with TGCT
Measured: through study completion, an average of 3 year
ORR per TVS (Tumor Volume Score) at Week 24
Tumor response will be assessed by an independent radiological reviewer per TVS.
Measured: at Week 24
Change from Baseline in Range of Motion (ROM) at Week 24
Active and passive ROM of the affected and non-affected joints will be assessed
Measured: at Week 24
Change from baseline in PROMIS Physical Function score at Week 24
PROMIS(Patient-reported Outcomes Measurement Information System) Physical Function Score
Measured: at Week 24
Change from baseline in the Worst Stiffness NRS score at Week 24
NRS（Numeric rating scale） ranges from 0 to10, 0 is equivalent to no Stiffness and 10 indicates the worst possible Stiffness.
Measured: at Week 24
Change from baseline in EQ-VAS (self-rated health scale) at Week 24
The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-VAS ranges from 0 to 100. Higher scores indicate better perceived health.
Measured: at Week 24
Proportion of participants with at least 30% improvement in mean BPI Worst Pain NRS score, without a 30% or greater increase in narcotic analgesic use at Week 24
BPI(Brief Pain Inventory) Worst Pain NRS ranges from 0 to10, 0 is equivalent to no pain and 10 indicates the worst possible pain.
Measured: at Week 24
Best of response per RECIST v1.1
Measured: through study completion, an average of 3 year
Best of response per TVS
Measured: through study completion, an average of 3 year
Duration of response per RECIST v1.1
Measured: through study completion, an average of 3 year
Duration of response per TVS
Measured: through study completion, an average of 3 year
Plasma DCC-3014 concentration
Measured: from Week 0 to Week 24
Plasma DP-7005 concentration
Measured: from Week 0 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tenosynovial Giant Cell TumorStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832747
- Sponsor's protocol ID
- DCC-3014-01
- Other IDs
- jRCT2031260479
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label, Non-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DCC-3014 in Japanese Subjects With Tenosynovial Giant Cell Tumor (TGCT)
- ClinicalTrials.gov ID
- NCT07832747
- Acronym / sponsor ID
- DCC-3014-01
- Conditions
- Tenosynovial Giant Cell Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 22 Sep 2026 (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.
To evaluate the efficacy, safety, and pharmacokinetics of DCC-3014 in subjects with Tenosynovial Giant Cell Tumor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCC-3014 | Experimental | Drug: DCC-3014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of TGCT (tumor biopsy to confirm diagnosis will be required if no histology/pathology is available at screening), and a TGCT in a single joint that can be assessed for range of motion (ROM)
- TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity
- Participants who have symptoms defined as at least moderate pain or at least moderate stiffness during the screening period
- Other protocol defined inclusion criteria may apply
Key exclusion criteria (4 listed)
- Metastatic TGCT or other active malignancy that requires treatment, or history of malignancy within 5 years prior to initiation of the screening period (excluding non-metastatic squamous cell carcinoma, basal cell carcinoma, or cervix carcinoma in situ with documented cure)
- QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females, or history of long QT syndrome
- Active liver or biliary disease, including nonalcoholic steatohepatitis (NASH) or cirrhosis
- Other protocol defined exclusion criteria may apply
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 |
|---|---|---|
| DCC-3014DCC-3014 will be orally administered at a dose of 30 mg twice weekly. | Drug | DCC-3014 |
Primary outcome
ORR at Week 24
Time frame: at Week 24
Proportion of participants with a response of CR or PR based on independent radiological review, per RECIST v1.1
13 secondary outcomes
Adverse events
Time frame: through study completion, an average of 3 year
ORR per TVS (Tumor Volume Score) at Week 24
Time frame: at Week 24
Change from Baseline in Range of Motion (ROM) at Week 24
Time frame: at Week 24
Change from baseline in PROMIS Physical Function score at Week 24
Time frame: at Week 24
Change from baseline in the Worst Stiffness NRS score at Week 24
Time frame: at Week 24
Change from baseline in EQ-VAS (self-rated health scale) at Week 24
Time frame: at Week 24
Proportion of participants with at least 30% improvement in mean BPI Worst Pain NRS score, without a 30% or greater increase in narcotic analgesic use at Week 24
Time frame: at Week 24
Best of response per RECIST v1.1
Time frame: through study completion, an average of 3 year
Best of response per TVS
Time frame: through study completion, an average of 3 year
Duration of response per RECIST v1.1
Time frame: through study completion, an average of 3 year
Duration of response per TVS
Time frame: through study completion, an average of 3 year
Plasma DCC-3014 concentration
Time frame: from Week 0 to Week 24
Plasma DP-7005 concentration
Time frame: from Week 0 to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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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.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
Project Leader study director
Ono 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 2 study testing DCC-3014 in people with Tenosynovial Giant Cell Tumor, run by Ono 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 4 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: opening soon, as of the sponsor's last update on 22 Sep 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact North America Clinical Trial Support Desk (+18665877745 (Toll-Free), clinical_trial@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR at Week 24 (time frame: at Week 24). 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 22 Sep 2026.