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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05349643
Registration number
NCT05349643
Ethics application status
Date submitted
22/04/2022
Date registered
27/04/2022
Titles & IDs
Public title
A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT
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Scientific title
A Phase 2, Open-Label, Adaptive, Dose-Ranging Study With Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra Articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor
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Secondary ID [1]
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0
AMB-051-07
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pigmented Villonodular Synovitis
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0
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TGCT
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Tenosynovial Giant Cell Tumor
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Condition category
Condition code
Cancer
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0
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0
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Bone
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Cancer
0
0
0
0
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Other cancer types
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Musculoskeletal
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0
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - AMB-05X
Experimental: AMB-05X - Subjects will receive an injection of AMB-05X once every 4 weeks for 24 weeks (for 6 treatments total). Based on ongoing review of the available safety, PK, PD, and efficacy data, the Sponsor may either increase or decrease the dose.
Treatment: Other: AMB-05X
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate - Part 1
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Assessment method [1]
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Proportion of subjects who achieve an OR (objective response rate \[ORR\]) by central radiology review per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [1]
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Part 1 Week 24
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Primary outcome [2]
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Treatment-emergent adverse events
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Assessment method [2]
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Frequency and severity of reported treatment-emergent adverse events
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Timepoint [2]
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Part 1 Week 24 and Part 2 Week 72
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Secondary outcome [1]
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Objective Response Rate
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Assessment method [1]
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Proportion of subjects who achieve an OR (objective response rate \[ORR\]) by central radiology review per modified Response Evaluation Criteria in Solid Tumors
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Timepoint [1]
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Part 2 Week 72
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Secondary outcome [2]
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Objective Response Rate (AMB-051-01 subjects)
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Assessment method [2]
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Proportion of re-treated subjects who achieve an OR (objective response rate \[ORR\]) by central radiology review per modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
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Timepoint [2]
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Part 2 Week 72
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Secondary outcome [3]
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Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1
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Assessment method [3]
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Proportion of subjects who achieve an overall response (OR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [3]
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Part 1 Week 24
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Secondary outcome [4]
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Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1
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Assessment method [4]
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Proportion of subjects who achieve an overall response (OR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [4]
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Part 2 Week 72
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Secondary outcome [5]
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Tumor response based on tumor volume score (TVS)
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Assessment method [5]
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Proportion of subjects who achieve an overall tumor response (OR) per the tumor volume score
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Timepoint [5]
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Part 1 Week 24
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Secondary outcome [6]
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Tumor response based on tumor volume score (TVS)
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Assessment method [6]
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Proportion of subjects who achieve an overall tumor response (OR) per the tumor volume score
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Timepoint [6]
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Part 2 Week 72
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Secondary outcome [7]
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Duration of Response by Response Evaluation Criteria in Solid Tumors
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Assessment method [7]
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Median duration of response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [7]
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Part 1 Week 24
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Secondary outcome [8]
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Duration of Response by Response Evaluation Criteria in Solid Tumors v1.1
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Assessment method [8]
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Median duration of response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [8]
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Part 2 Week 72
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Secondary outcome [9]
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Duration of Response by Modified Response Evaluation Criteria in Solid Tumors
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Assessment method [9]
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Median duration of response per modified Response Evaluation Criteria in Solid Tumors (modified RECIST)
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Timepoint [9]
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Part 1 Week 24
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Secondary outcome [10]
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0
Duration of Response by Modified Response Evaluation Criteria in Solid Tumors
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Assessment method [10]
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Median duration of response per modified Response Evaluation Criteria in Solid Tumors (modified RECIST)
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Timepoint [10]
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Part 2 Week 72
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Secondary outcome [11]
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Duration of Response by tumor volume score
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Assessment method [11]
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Median duration of response per tumor volume score (TVS)
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Timepoint [11]
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Part 1 Week 24
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Secondary outcome [12]
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0
Duration of Response by tumor volume score
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Assessment method [12]
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Median duration of response per tumor volume score (TVS)
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Timepoint [12]
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Part 2 Week 72
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Secondary outcome [13]
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Time to Response by Response Evaluation Criteria in Solid Tumors
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Assessment method [13]
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Time to response (TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [13]
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Part 1 Week 24
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Secondary outcome [14]
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Time to Response by Response Evaluation Criteria in Solid Tumors
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Assessment method [14]
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Time to response (TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [14]
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Part 2 Week 72
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Secondary outcome [15]
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Time to Response by Modified Response Evaluation Criteria in Solid Tumors
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Assessment method [15]
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Time to response (TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [15]
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Part 1 week 24
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Secondary outcome [16]
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Time to Response by Modified Response Evaluation Criteria in Solid Tumors
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Assessment method [16]
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Time to response (TTR) per modified Response Evaluation Criteria in Solid Tumors (modified RECIST)
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Timepoint [16]
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Part 2 Week 72
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Secondary outcome [17]
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Time to Response per tumor volume score
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Assessment method [17]
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Time to response (TTR) per tumor volume score (TVS)
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Timepoint [17]
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Part 1 Week 24
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Secondary outcome [18]
0
0
Time to Response per tumor volume score
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Assessment method [18]
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Time to response (TTR) per tumor volume score (TVS)
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Timepoint [18]
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Part 2 Week 72
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Secondary outcome [19]
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Mean change from Baseline in joint range of motion (ROM)
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Assessment method [19]
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Mean change in joint range of motion (ROM) will be assessed by qualified assessors. Measurements will be recorded in degrees. At baseline, the plane of movement with the smallest (worst) relative value will be identified; only this plane will be used for evaluating change in ROM subsequently.
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Timepoint [19]
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Part 1 Week 24
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Secondary outcome [20]
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Mean change from Baseline in joint range of motion (ROM)
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Assessment method [20]
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Mean change in joint range of motion (ROM) will be assessed by qualified assessors. Measurements will be recorded in degrees. At baseline, the plane of movement with the smallest (worst) relative value will be identified; only this plane will be used for evaluating change in ROM subsequently.
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Timepoint [20]
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Part 2 Week 72
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Secondary outcome [21]
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Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score
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Assessment method [21]
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The Patient-Reported Outcomes Measurement Information System (PROMIS) is a 10-question patient reported outcome instrument used to assess physical functioning based on use of the upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back) and on instrumental activities of daily living. Five questions address the degree to which subject's health limits activities; subjects select responses ranging from 1-cannot do to 5 - not at all. Five additional questions address the degree to which the subject is able to perform certain physical activities, and subjects select a response to each question that ranges from 1 ("cannot do") to 5 ("without any difficulty"). Raw scores are summarized, score range is 10 to 50.
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Timepoint [21]
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Part 1 Week 24
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Secondary outcome [22]
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Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score
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Assessment method [22]
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0
The Patient-Reported Outcomes Measurement Information System (PROMIS) is a 10-question patient reported outcome instrument used to assess physical functioning based on use of the upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back) and on instrumental activities of daily living. Five questions address the degree to which subject's health limits activities; subjects select responses ranging from 1-cannot do to 5 - not at all. Five additional questions address the degree to which the subject is able to perform certain physical activities, and subjects select a response to each question that ranges from 1 ("cannot do") to 5 ("without any difficulty"). Raw scores are summarized, score range is 10 to 50.
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Timepoint [22]
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0
Part 2 Week 72
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Secondary outcome [23]
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Mean change from Baseline in Worst Stiffness Numeric Rating Scale score
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Assessment method [23]
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The Worst Stiffness Numeric Rating Scale (NRS) is a 1-item, self-administered questionnaire assessing the "worst" stiffness within the last 24 hours. The NRS for this item ranges from 0 (no stiffness) to 10 (stiffness as bad as you can imagine). Higher scores indicate worst stiffness.
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Timepoint [23]
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Part 1 Week 24
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Secondary outcome [24]
0
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Mean change from Baseline in Worst Stiffness Numeric Rating Scale score
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Assessment method [24]
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0
The Worst Stiffness Numeric Rating Scale (NRS) is a 1-item, self-administered questionnaire assessing the "worst" stiffness within the last 24 hours. The NRS for this item ranges from 0 (no stiffness) to 10 (stiffness as bad as you can imagine). Higher scores indicate worst stiffness.
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Timepoint [24]
0
0
Part 2 Week 72
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Secondary outcome [25]
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0
Mean change from Baseline in the Brief Pain Inventory (BPI) score
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Assessment method [25]
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Brief Pain Inventory (BPI) Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. The subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 ="no pain" to 10= "pain as bad as you can imagine".
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Timepoint [25]
0
0
Part 1 Week 24
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Secondary outcome [26]
0
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Mean change from Baseline in the Brief Pain Inventory (BPI) score
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Assessment method [26]
0
0
Brief Pain Inventory (BPI) Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. The subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 ="no pain" to 10="pain as bad as you can imagine".
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Timepoint [26]
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Part 2 Week 72
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Secondary outcome [27]
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Decrease of at least 30% in mean Brief Pain Inventory (BPI) from Baseline
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Assessment method [27]
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Brief Pain Inventory (BPI) Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. The subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 ="no pain" to 10="pain as bad as you can imagine".
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Timepoint [27]
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0
Part 1 Week 24
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Secondary outcome [28]
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Decrease of at least 30% in mean Brief Pain Inventory (BPI) from Baseline
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Assessment method [28]
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0
Brief Pain Inventory (BPI) Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. The subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 ="no pain" to 10="pain as bad as you can imagine".
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Timepoint [28]
0
0
Part 2 Week 72
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Secondary outcome [29]
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Mean change from Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference score
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Assessment method [29]
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The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.1 Pain Interference Short Form 8a, is an 8 question instrument used to evaluate how much a subject's pain interferes with daily functioning. Subjects rate the degree to which pain interfered with their daily activity over the past 7 days on a scale of 1 to 5 (ranging from 1, "Not at all," to 5, "Very much"). Higher scores indicate greater pain interference.
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Timepoint [29]
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Part 1 Week 24
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Secondary outcome [30]
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Mean change from Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference score
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Assessment method [30]
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The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.1 Pain Interference Short Form 8a, is an 8 question instrument used to evaluate how much a subject's pain interferes with daily functioning. Subjects rate the degree to which pain interfered with their daily activity over the past 7 days on a scale of 1 to 5 (ranging from 1, "Not at all," to 5, "Very much"). Higher scores indicate greater pain interference.
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Timepoint [30]
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Part 2 Week 72
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Secondary outcome [31]
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Mean change from Baseline in Patient Global Impression of Change in Physical Functioning for capacity to perform everyday tasks
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Assessment method [31]
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The Patient Global Impression of Change (PGIC), also known as Subject Global Impression. For this study, subjects will rate how much their tenosynovial giant cell tumor (TGCT) has restricted their ability to perform everyday tasks, using the following scales that are based on the PGIC: PGIC Physical Functioning scale (ranging from 1 "Not at all," to 5 "Extremely" and rate their change in stiffness using the PGIC Stiffness scale (ranging from 1 "Very much improved" to 7 "Very much worse". Higher scores indicate greater restrictions.
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Timepoint [31]
0
0
Part 1 Week 24
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Secondary outcome [32]
0
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Mean change from Baseline in Patient Global Impression of Change in Physical Functioning for capacity to perform everyday tasks
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Assessment method [32]
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The Patient Global Impression of Change (PGIC), also known as Subject Global Impression. For this study, subjects will rate how much their tenosynovial giant cell tumor (TGCT) has restricted their ability to perform everyday tasks, using the following scales that are based on the PGIC: PGIC Physical Functioning scale (ranging from 1, "Not at all," to 5, "Extremely" and rate their change in stiffness using the PGIC Stiffness scale (ranging from 1 "Very much improved" to 7 "Very much worse". Higher scores indicate greater restrictions.
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Timepoint [32]
0
0
Part 2 Week 72
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Secondary outcome [33]
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Mean change from Baseline in Patient Global Impression of Change in tenosynovial giant cell tumor-related stiffness score
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Assessment method [33]
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The Patient Global Impression of Change (PGIC), also known as Subject Global Impression. For this study, subjects will rate how much their tenosynovial giant cell tumor (TGCT) has restricted their ability to perform everyday tasks, using the PGIC to rate their change in stiffness using the PGIC Stiffness scale, ranging from 1, "Very much improved" to 7, "Very much worse". Higher scores indicate greater TGCT-related levels of stiffness.
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Timepoint [33]
0
0
Part 1 Week 24
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Secondary outcome [34]
0
0
Mean change from Baseline in Patient Global Impression of Change in tenosynovial giant cell tumor-related stiffness score
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Assessment method [34]
0
0
The Patient Global Impression of Change (PGIC), also known as Subject Global Impression. For this study, subjects will rate how much their TGCT has restricted their ability to perform everyday tasks, using the PGIC to rate their change in stiffness using the PGIC Stiffness scale, ranging from 1, "Very much improved" to 7, "Very much worse". Higher scores indicate greater TGCT-related levels of stiffness.
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Timepoint [34]
0
0
Part 2 Week 72
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Secondary outcome [35]
0
0
Mean change from Baseline in Worst Pain Numeric Rating Scale score
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Assessment method [35]
0
0
The Worst Pain Numeric Rating Scale (NRS) is an item in the Brief Pain Inventory (BPI) that assesses a subject's "worst" pain in the last 24 hours. The 11-point NRS for this item ranges from 0 ("no pain") to 10 ("pain as bad as you can imagine"). Higher scores indicate greater levels of pain.
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Timepoint [35]
0
0
Part 1 Week 24
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Secondary outcome [36]
0
0
Mean change from Baseline in Worst Pain Numeric Rating Scale score
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Assessment method [36]
0
0
The Worst Pain Numeric Rating Scale (NRS) is an item in the Brief Pain Inventory (BPI) that assesses a subject's "worst" pain in the last 24 hours. The 11-point NRS for this item ranges from 0 ("no pain") to 10 ("pain as bad as you can imagine"). Higher scores indicate greater levels of pain.
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Timepoint [36]
0
0
Part 2 Week 72
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Secondary outcome [37]
0
0
EuroQol 5 Dimension 5 Level Health Assessment
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Assessment method [37]
0
0
EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a widely used quality of life instrument that includes questions in each of 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The choices include 5 levels of severity for each domain followed by a general health visual analogue scale (VAS). This instrument is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems". Higher scores indicate a lower quality of life.
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Timepoint [37]
0
0
Part 1 Week 24
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Secondary outcome [38]
0
0
EuroQol 5 Dimension 5 Level Health Assessment
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Assessment method [38]
0
0
EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a widely used quality of life instrument that includes questions in each of 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The choices include 5 levels of severity for each domain followed by a general health visual analogue scale (VAS). This instrument is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems". Higher scores indicate a lower quality of life.
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Timepoint [38]
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Part 2 Week 72
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Eligibility
Key inclusion criteria
1. Subject = 18 years
2. TGCT with only 1 joint involvement
3. Symptomatic Measurable disease of at least 1 cm based on RECIST v1.1
4. Stable prescription of analgesic regimen
5. Agrees to follow contraception guidelines
6. Women of childbearing potential must have a negative pregnancy test
7. Adequate hematologic, hepatic, and renal function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
2. Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors within 3 months prior to Baseline
3. History of extensive or reconstructive surgery on the affected joint
4. Active cancer (either currently or within 3 mo before Baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy)
5. Metastatic or malignant transformation of TGCT
6. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
7. Known active tuberculosis
8. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
9. Women who are breastfeeding
10. A screening Fridericia-corrected QT interval (QTcF) = 470 ms
11. MRI contraindications (e.g., pacemaker, loose metallic implants)
12. History of hypersensitivity to any ingredient of the study drug
13. History of drug or alcohol abuse within 3 months before baseline
14. Any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment or interfere with interpretation of study results and, in the Investigator's opinion, make the subject inappropriate for this study
15. Subjects who, in the Investigator's opinion, should not participate in the study for any reason, including if there is a question about their ability to comply with study requirements
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/06/2024
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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0
AmMax Bio, Clinical Site - Camperdown
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Recruitment hospital [2]
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0
AmMax Bio, Clinical Site - Woolloongabba
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Recruitment postcode(s) [1]
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0
- Camperdown
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Recruitment postcode(s) [2]
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0
- Woolloongabba
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Texas
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Country [4]
0
0
Netherlands
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State/province [4]
0
0
Leiden
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AmMax Bio, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor
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Trial website
https://clinicaltrials.gov/study/NCT05349643
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Dorothy Nguyen, MD
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Address
0
0
AmMax Bio
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Tiffany Nguyen
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Address
0
0
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Country
0
0
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Phone
0
0
6502856560
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05349643