A Phase 4 interventional study of Pexidartinib in Tenosynovial Giant Cell Tumor, sponsored by Daiichi Sankyo. Completed at 16 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Daiichi Sankyo · Phase 4, Interventional, and Treatment
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Among 16 studies in Giant Cell Tumor of Tendon Sheath with a site in United States — 2 open to participants now, 5 under way, 2 of them phase 3. Giant Cell Tumor of Tendon Sheath · United States.
Among the 16 studies in Giant Cell Tumor of Tendon Sheath with a site in United States, this one is the 9th largest by enrollment of the 14 interventional ones that give a count, is one of 3 that started in 2020, is the only one in phase 4, and was the 10th registered.
22 studies on the registry are indexed under Giant Cell Tumor of Tendon Sheath; 5 are open to participants now.
Browse Giant Cell Tumor of Tendon Sheath studies →2 of the 16 studies in Giant Cell Tumor of Tendon Sheath with a site in United States are open now. Recruiting first, the newest first:
Deciphera Pharmaceuticals, LLC · Sites in United States
Ages 18+
Abbisko Therapeutics Co, Ltd · Sites in United States, China
Ages 12+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 4 Giant Cell Tumor of Tendon Sheath studies recruiting now, 3 set no upper age limit and 1 stops at 75 or younger; 1 takes children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 6 · Phase 3 3 · Phase 4 1
First in 2010; this study’s year is marked. 3 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is close to the median of 34 across 20 interventional studies indexed under Giant Cell Tumor of Tendon Sheath.
Median enrollment 48 across the 14 interventional studies, 50 across the 2 observational. Of the 10 that completed or were terminated, 7 (70%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 16 have an industry lead sponsor. The 8 most frequent:
Daiichi Sankyo is the lead sponsor of 322 studies on the registry; 37 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Daiichi Sankyo has 8 studies filed under Giant Cell Tumor of Tendon Sheath — fewer than ten, so there is no comparison to draw.
1 of the studies in Giant Cell Tumor of Tendon Sheath with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07075471Deciphera Pharmaceuticals, LLCMOVE: Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib | 2027-09 |
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Among the 16 studies in Giant Cell Tumor of Tendon Sheath with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is designed to evaluate the discontinuation/re-treatment of pexidartinib therapy in previously treated participants with tenosynovial giant cell tumor (TGCT).
This multicenter study in previously pexidartinib-treated participants with TGCT will provide the Investigators and participants the option at Screening to either continue pexidartinib treatment (Treatment Continuation Cohort) or discontinue treatment with the possibility of re-initiating pexidartinib treatment (Treatment-Free/Re-Treatment Cohort).
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.
Note: A female is considered of reproductive potential following menarche and until becoming (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with a confirmed by follicle stimulating hormone (FSH) test level >40 mIU/mL.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Previously-treated participants with TGCT continuing their current dose of pexidartinib treatment.
Drug: Pexidartinib
Previously-treated participants with TGCT who discontinue pexidartinib treatment (Treatment-Free Period) and had the option to resume pexidartinib treatment at dose at completion of prior study (Re-Treatment Period).
Drug: Pexidartinib
200 mg capsules administered orally twice daily on an empty stomach (at least 1 hour before or at least 2 hours after a meal or snack)
Also known as: TURALIO™️, PLX3397
Number of Treatment-Free Participants at 12 Months In The Treatment-free/Re-treatment Cohort
Participants who were not remaining treatment-free were defined as either participants who resumed pexidartinib treatment, death (any cause) or who were receiving systemic therapy or undergoing surgery for the treatment of TGCT, whichever occurs first. The number of participants who remained treatment-free at Month 12 is reported.
Time frame: Baseline up to 12 months after last participant enrolled in Cohort
Number of Treatment-Free Participants at 24 Months In The Treatment-free/Re-treatment Cohort
Participants who were not remaining treatment-free were defined as either participants who resumed pexidartinib treatment, death (any cause) or who were receiving systemic therapy or undergoing surgery for the treatment of TGCT, whichever occurs first. The number of participants who remained treatment-free at Month 24 is reported.
Time frame: Baseline up to 24 months after last participant enrolled in Cohort
Change From Baseline in PROMIS Physical Function Total Overall Score In The Treatment Continuation and Treatment-free/Re-Treatment Cohorts
The PROMIS Physical Function Total Overall Score (includes 11 upper extremity questions and 13 lower extremity questions) ranges from 24 to 120, with each individual question being rated on a 5-point rating scale (where 1 is unable to do and 5 is without any difficulty). Higher PROMIS Physical Function Total Overall Scores indicate a better health state. The change from baseline in PROMIS Physical Function Total Overall Scores is being reported.
Time frame: Baseline up to Month 24
Change From Baseline in EQ-5D-5L Scale Score In The Treatment Continuation and Treatment-free/Re-Treatment Cohorts
The EQ-5D-5L questionnaire assessed a participant's mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The overall health is rated on a scale from 0 to 100, where 0 is worst health you can imagine and 100 is best health you can imagine. The change from baseline in EQ-5D-5L Scale Score is being reported.
Time frame: Baseline up to Month 24
Number of Participants With and Without Progressive Disease
Tumors were assessed based on the RECIST criteria. CR was defined as a disappearance of all target lesions, 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; ≥30% increase in volume relative to lowest score during the study whether at baseline or some other visit.
Time frame: Month 18 (Re-treatment Period of the Treatment-free/Re-treatment Cohort), Month 24 (Treatment Continuation Cohort)
Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) In The Treatment Continuation Cohort
Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) or pre-existing conditions that worsen in CTCAE grade after the first dose of study drug and up to 30 days after last dose of study drug.
Time frame: Baseline up to 30 days after the start of re-treatment or end of study (whichever occurs first), up to 24 months
Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) In The Re-Treatment Period of the Treatment-free/Re-Treatment Cohort
Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) or pre-existing conditions that worsen in CTCAE grade after the first dose of study drug and up to 30 days after last dose of study drug.
Time frame: Baseline up to 30 days after the start of re-treatment or end of study (whichever occurs first), up to 24 months
Number of Patients Reporting AEs (Treatment-free)
Adverse events (AEs) were defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. Participants who were not remaining treatment-free were defined as either participants who resumed pexidartinib treatment, death (any cause) or who were receiving systemic therapy or undergoing surgery for the treatment of TGCT, whichever occurs first.
Time frame: Baseline up to 30 days after the start of re-treatment or end of study (whichever occurs first), up to 24 months
A total of 32 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study.
| Milestone | Treatment Continuation Cohort | Treatment-Free/Re-Treatment Cohort |
|---|---|---|
| Started | 21 | 11 |
| Resumed pexidartinib treatment | 0 | 3 |
| Completed | 17 | 11 |
| Not completed | 4 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
Participants who were not remaining treatment-free were defined as either participants who resumed pexidartinib treatment, death (any cause) or who were receiving systemic therapy or undergoing surgery for the treatment of TGCT, whichever occurs first. The number of participants who remained treatment-free at Month 12 is reported.
| Participants | Treatment-Free/Re-Treatment Cohort |
|---|---|
| Number of Treatment-Free Participants at 12 Months In The Treatment-free/Re-treatment Cohort | 8 |
Participants who were not remaining treatment-free were defined as either participants who resumed pexidartinib treatment, death (any cause) or who were receiving systemic therapy or undergoing surgery for the treatment of TGCT, whichever occurs first. The number of participants who remained treatment-free at Month 24 is reported.
| Participants | Treatment-Free/Re-Treatment Cohort |
|---|---|
| Number of Treatment-Free Participants at 24 Months In The Treatment-free/Re-treatment Cohort | 8 |
The PROMIS Physical Function Total Overall Score (includes 11 upper extremity questions and 13 lower extremity questions) ranges from 24 to 120, with each individual question being rated on a 5-point rating scale (where 1 is unable to do and 5 is without any difficulty). Higher PROMIS Physical Function Total Overall Scores indicate a better health state. The change from baseline in PROMIS Physical Function Total Overall Scores is being reported.
| score on a scale | Treatment Continuation Cohort | Treatment-Free/Re-Treatment Cohort |
|---|---|---|
| Change From Baseline in PROMIS Physical Function Total Overall Score In The Treatment Continuation and Treatment-free/Re-Treatment Cohorts | -2.78 ± 6.42 | -1.93 ± 4.80 |
The EQ-5D-5L questionnaire assessed a participant's mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The overall health is rated on a scale from 0 to 100, where 0 is worst health you can imagine and 100 is best health you can imagine. The change from baseline in EQ-5D-5L Scale Score is being reported.
| score on a scale | Treatment Continuation Cohort | Treatment-Free/Re-Treatment Cohort |
|---|---|---|
| Change From Baseline in EQ-5D-5L Scale Score In The Treatment Continuation and Treatment-free/Re-Treatment Cohorts | -2.4 ± 13.53 | 3.4 ± 7.59 |
Tumors were assessed based on the RECIST criteria. CR was defined as a disappearance of all target lesions, 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; ≥30% increase in volume relative to lowest score during the study whether at baseline or some other visit.
| Participants | Treatment Continuation Cohort | Treatment-Free/Re-Treatment Cohort |
|---|---|---|
| Not progressive | 16 | 0 |
| Progressive disease | 0 | 1 |
| Not evaluable | 0 | 0 |
Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) or pre-existing conditions that worsen in CTCAE grade after the first dose of study drug and up to 30 days after last dose of study drug.
| Participants | Treatment Continuation Cohort |
|---|---|
| Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) In The Treatment Continuation Cohort | 19 |
Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) or pre-existing conditions that worsen in CTCAE grade after the first dose of study drug and up to 30 days after last dose of study drug.
| Participants | Treatment-Free/Re-Treatment Cohort |
|---|---|
| Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) In The Re-Treatment Period of the Treatment-free/Re-Treatment Cohort | 3 |
Adverse events (AEs) were defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. Participants who were not remaining treatment-free were defined as either participants who resumed pexidartinib treatment, death (any cause) or who were receiving systemic therapy or undergoing surgery for the treatment of TGCT, whichever occurs first.
| Participants | Treatment-Free/Re-Treatment Cohort |
|---|---|
| Any Grade AE | 7 |
| Any Grade Musculoskeletal/Tissue Disorders | 6 |
| Any Grade Arthralgia | 2 |
| Any Grade Back pain | 2 |
| Any Grade Intervertebral disc protrusion | 1 |
| Any Grade Joint swelling | 1 |
| Any Grade Musculoskeletal pain | 1 |
| Any Grade Pain in extremity | 1 |
| Any Grade Metabolism and Nutrition Disorders | 3 |
| Any Grade Hypercholesterolaemia | 2 |
| Any Grade Hypertriglyceridaemia | 2 |
| Any Grade General Disorders & Site Conditions | 2 |
| Any Grade Asthenia | 1 |
| Any Grade Oedema peripheral | 1 |
| Any Grade Infections and Infestations | 2 |
| Any Grade Cellulitis | 1 |
| Any Grade COVID-19 | 1 |
| Any Grade investigations | 2 |
| Any Gr Blood creatinine phosphokinase increased | 2 |
| Any Grade Blood uric acid increased | 1 |
| Any Renal and Urinary Disorders | 2 |
| Any Renal colic | 1 |
| Any Grade Urinary retention | 1 |
| Any Grade Injury, Poisoning & Procedural Issues | 1 |
| Any Grade Animal bite | 1 |
| Any Grade Neoplasms Benign, Malignant & Other | 1 |
| Any Grade Lipoma | 1 |
| Any Grade Nervous System Disorders | 1 |
| Any Grade Sciatica | 1 |
| Any Grade Skin and Subcutaneous Tissue Disorders | 1 |
| Any Grade Urticaria | 1 |
Collected over Treatment-emergent adverse events were collected from baseline up to 30 days after the start of re-treatment or end of study (whichever occurs first), up to 24 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Continuation Cohort | 0/21 (0%) | 2/21 (9.5%) | 19/21 (90.5%) |
| Re-Treatment Period of Treatment-Free/Re-Treatment Cohort | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Treatment-Free Period of Treatment-Free/Re-treatment Cohort | 0/11 (0%) | 0/11 (0%) | 7/11 (63.6%) |
| Event | Treatment Continuation Cohort | Re-Treatment Period of Treatment-Free/Re-Treatment Cohort | Treatment-Free Period of Treatment-Free/Re-treatment Cohort |
|---|---|---|---|
| Creutzfeldt-Jakob diseaseInfections and infestations | 1/21 | 0/3 | 0/11 |
| Device dislocationProduct Issues | 1/21 | 0/3 | 0/11 |
| Event | Treatment Continuation Cohort | Re-Treatment Period of Treatment-Free/Re-Treatment Cohort | Treatment-Free Period of Treatment-Free/Re-treatment Cohort |
|---|---|---|---|
| COVID-19Infections and infestations | 7/21 | 2/3 | 1/11 |
| Blood creatinine phosphokinase increasedInvestigations | 8/21 | 2/3 | 2/11 |
| Hair colour changesSkin and subcutaneous tissue disorders | 1/21 | 2/3 | 0/11 |
| PruritusSkin and subcutaneous tissue disorders | 1/21 | 2/3 | 0/11 |
| SinusitisInfections and infestations | 0/21 | 1/3 | 0/11 |
| Aspartate aminotransferase increasedInvestigations | 5/21 | 1/3 | 0/11 |
| Alanine aminotransferase increasedInvestigations | 2/21 | 1/3 | 0/11 |
| Blood lactate dehydrogenase increasedInvestigations | 1/21 | 1/3 | 0/11 |
| SARS-CoV-2 test positiveInvestigations | 1/21 | 1/3 | 0/11 |
| Lymphocyte count decreasedInvestigations | 0/21 | 1/3 | 0/11 |
Demographic and baseline characteristics were assessed in the Full Analysis Set.
| Age, Continuous(years) | Treatment Continuation Cohort | Treatment-Free/Re-Treatment Cohort | Total |
|---|---|---|---|
| Mean | 46.2 ± 15.7 | 51.9 ± 15.2 | 48.2 ± 15.5 |
| Age, Customized(Participants) | Treatment Continuation Cohort | Treatment-Free/Re-Treatment Cohort | Total |
|---|---|---|---|
| 18 to 40 years | 7 | 1 | 8 |
| 41 to 64 years | 12 | 8 | 20 |
| 65 to 74 years | 1 | 1 | 2 |
| 75 to 84 years | 1 | 1 | 2 |
| ≥ 85 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Treatment Continuation Cohort | Treatment-Free/Re-Treatment Cohort | Total |
|---|---|---|---|
| Female | 12 | 4 | 16 |
| Male | 9 | 7 | 16 |
| Race/Ethnicity, Customized(Participants) | Treatment Continuation Cohort | Treatment-Free/Re-Treatment Cohort | Total |
|---|---|---|---|
| Asian | 1 | 1 | 2 |
| White | 19 | 8 | 27 |
| Not collected per local regulations | 1 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Data sharing details ↗ · vivli.org
Ran from Oct 2020 to primary completion in Jul 2023, 32 months.
Results were first posted in Dec 2024, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Pexidartinib
Giant Cell Tumor of Tendon Sheath →