A Phase 2 interventional study of DCC-3014 in Tenosynovial Giant Cell Tumor, sponsored by Ono Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
To evaluate the efficacy, safety, and pharmacokinetics of DCC-3014 in subjects with Tenosynovial Giant Cell Tumor
22 studies on the registry are indexed under Giant Cell Tumor of Tendon Sheath; 5 are open to participants now.
This study's planned enrollment of 18 is below the median of 34 across 20 interventional studies indexed under Giant Cell Tumor of Tendon Sheath.
Browse Giant Cell Tumor of Tendon Sheath studies →Ono Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: DCC-3014
DCC-3014 will be orally administered at a dose of 30 mg twice weekly.
ORR at Week 24
Proportion of participants with a response of CR or PR based on independent radiological review, per RECIST v1.1
Time frame: at Week 24
Adverse events
To assess the safety of DCC-3014 in Japanese patients with TGCT
Time frame: 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.
Time frame: 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
Time frame: at Week 24
Change from baseline in PROMIS Physical Function score at Week 24
PROMIS(Patient-reported Outcomes Measurement Information System) Physical Function Score
Time frame: 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.
Time frame: 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.
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
BPI(Brief Pain Inventory) Worst Pain NRS ranges from 0 to10, 0 is equivalent to no pain and 10 indicates the worst possible pain.
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2028, 22 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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