A Phase 2 interventional study of Pimicotinib in Tenosynovial Giant Cell Tumor, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. Recruiting at 4 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Phase 2, Interventional, and Treatment
The primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT
The purpose of this study is to assess the tolerability, pharmacokinetics (PK), efficacy, and safety of pimicotinib in Japanese participants with TGCT in two cohorts: Safety Run-in and Expansion.
23 studies on the registry are indexed under Giant Cell Tumor of Tendon Sheath; 6 are open to participants now.
This study's planned enrollment of 20 is below the median of 38 across 20 interventional studies indexed under Giant Cell Tumor of Tendon Sheath.
Browse Giant Cell Tumor of Tendon Sheath studies →Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany is the lead sponsor of 55 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Pimicotinib
In the Safety Run-in Cohort, participants will receive 50 milligrams (mg) of pimicotinib once daily (QD), orally in 28-day cycles until disease progression (DP), death, discontinuation, or any other reason. The Safety Monitoring Committee (SMC) will monitor and assess tolerability of pimicotinib 50 mg QD during the safety run-in cohort. After making a recommendation about opening the Expansion Cohort based on the assessment in safety run-in cohort, participants will receive 50 mg of pimicotinib monotherapy QD, orally in 28-day cycles until disease progression (DP), death, discontinuation, or any other reason.
Safety Run-In Cohort: Number of Participants with Dose Limiting Toxicity (DLT)-like events
Time frame: Day 1 up to Day 28 of Cycle 1 (each cycle is of 28 days)
Safety Run-In Cohort: Pharmacokinetic (PK) Plasma Concentration of Pimicotinib
Time frame: Pre-dose up to 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is of 28 days)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee
Time frame: Time from first study treatment until progressive disease or death, assessed up to approximately 2 years
Objective Response (OR) According to Tumor Volume Score (TVS) as Assessed by Independent Review Committee (IRC)
Time frame: Time from first study treatment until progressive disease or death, assessed up to approximately 2 years
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by Investigator
Time frame: Time from first study treatment until progressive disease or death, assessed up to approximately 2 years
Mean Change from Baseline in Range of Motion (ROM) at Week 25
The ROM of the affected joint or tumor site will be assessed using a goniometer. Measurements will be recorded in degrees.
Time frame: Baseline, Week 25
Mean Change from Baseline in Worst-Stiffness-Numeric Rating Scale (NRS) Score at Week 25
Time frame: Baseline, Week 25
Mean Change from Baseline in Brief Pain Inventory (BPI)- Worst-Stiffness-Numeric Rating Scale (NRS) Score at Week 25
Time frame: Baseline, Week 25
Mean Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Physical Functioning Score at Week 25
The PROMIS Physical Function scale is measured using a series of questions assessing a person's ability to perform various physical tasks, with responses scored on a 5-point Likert scale. The raw score from these responses is then converted to a standardized T-score on a scale of 0 to 100, with a mean of 50 and a standard deviation of 10. The total score is the final T-score.
Time frame: Baseline, Week 25
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee
Time frame: Time from first documentation of objective response until progressive disease (PD) or death, assessed approximately up to 2 years
Duration of Response (DOR) According to Tumor Volume Score (TVS) as Assessed by Independent Review Committee (IRC)
Time frame: Time from first documentation of objective response until progressive disease (PD) or death, assessed approximately up to 2 years
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by Investigator
Time frame: Time from first documentation of objective response until progressive disease (PD) or death, assessed approximately up to 2 years
Mean Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Scale Score at Week 25
The EQ-5D-5L questionnaire is a standardized instrument used as a measure of health outcome. The 5-dimension health status measure evaluates: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: an extreme problem. Higher scores (closer to 5) indicate worse health status.
Time frame: Baseline, Week 25
Mean Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Week 25
The EQ-5D-5L questionnaire is a standardized instrument used as a measure of health outcome. The VAS records the participant's self-rated health on a vertical VAS where the endpoints are labelled 'Worst imaginable health state' and 'Best imaginable health state'. VAS ranges from 0 to 100. Higher scores indicate better perceived health.
Time frame: Baseline, Week 25
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events
Time frame: Time from first study treatment, assessed up to approximately 2 years
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Pimicotinib
Time frame: Pre-dose up to 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is of 28 days)
Accumulation Ratio for Maximum Observed Plasma Concentration [Racc(Cmax)] of Pimicotinib After Repeated Administration
Time frame: Pre-dose up to 24 hours post-dose on Cycle 1 Day 15 (each cycle is of 28 days)
Accumulation Ratio of Area Under the Plasma Concentration-Time Curve from Time Zero to 24 Hours (AUC0-24) of Pimicotinib After Repeated Administration
Time frame: Pre-dose up to 24 hours post-dose on Cycle 1 Day 15 (each cycle is of 28 days)
Plasma Concentration Observed at the End of a Dosing Interval Immediately before Next Dosing (Ctrough) of Pimicotinib
Time frame: Pre-dose on Cycle 1 Day 15 (each cycle is of 28 days)
Plan to share: Yes — IPD supporting publicly available results will be evaluated for sharing.
Supporting information: Study protocol, Sap, Csr, Analytic code
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany