Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 19 of 19

List	Outcome	Time frame	Description
Primary	Safety Run-In Cohort: Number of Participants with Dose Limiting Toxicity (DLT)-like events	Day 1 up to Day 28 of Cycle 1 (each cycle is of 28 days)
Primary	Safety Run-In Cohort: Pharmacokinetic (PK) Plasma Concentration of Pimicotinib	Pre-dose up to 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is of 28 days)
Primary	Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee	Time from first study treatment until progressive disease or death, assessed up to approximately 2 years
Secondary	Objective Response (OR) According to Tumor Volume Score (TVS) as Assessed by Independent Review Committee (IRC)	Time from first study treatment until progressive disease or death, assessed up to approximately 2 years
Secondary	Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by Investigator	Time from first study treatment until progressive disease or death, assessed up to approximately 2 years
Secondary	Mean Change from Baseline in Range of Motion (ROM) at Week 25	Baseline, Week 25	The ROM of the affected joint or tumor site will be assessed using a goniometer. Measurements will be recorded in degrees.
Secondary	Mean Change from Baseline in Worst-Stiffness-Numeric Rating Scale (NRS) Score at Week 25	Baseline, Week 25
Secondary	Mean Change from Baseline in Brief Pain Inventory (BPI)- Worst-Stiffness-Numeric Rating Scale (NRS) Score at Week 25	Baseline, Week 25
Secondary	Mean Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Physical Functioning Score at Week 25	Baseline, 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.
Secondary	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 from first documentation of objective response until progressive disease (PD) or death, assessed approximately up to 2 years
Secondary	Duration of Response (DOR) According to Tumor Volume Score (TVS) as Assessed by Independent Review Committee (IRC)	Time from first documentation of objective response until progressive disease (PD) or death, assessed approximately up to 2 years
Secondary	Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by Investigator	Time from first documentation of objective response until progressive disease (PD) or death, assessed approximately up to 2 years
Secondary	Mean Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Scale Score at Week 25	Baseline, 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.
Secondary	Mean Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Week 25	Baseline, 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.
Secondary	Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events	Time from first study treatment, assessed up to approximately 2 years
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Pimicotinib	Pre-dose up to 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is of 28 days)
Secondary	Accumulation Ratio for Maximum Observed Plasma Concentration [Racc(Cmax)] of Pimicotinib After Repeated Administration	Pre-dose up to 24 hours post-dose on Cycle 1 Day 15 (each cycle is of 28 days)
Secondary	Accumulation Ratio of Area Under the Plasma Concentration-Time Curve from Time Zero to 24 Hours (AUC0-24) of Pimicotinib After Repeated Administration	Pre-dose up to 24 hours post-dose on Cycle 1 Day 15 (each cycle is of 28 days)
Secondary	Plasma Concentration Observed at the End of a Dosing Interval Immediately before Next Dosing (Ctrough) of Pimicotinib	Pre-dose on Cycle 1 Day 15 (each cycle is of 28 days)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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