A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor

Conditions

Tenosynovial Giant Cell Tumor

Brief summary

25-Week Objective Response Rate (ORR) by Blinded Independent Review Committee (BIRC) based on RECIST 1.1.

Detailed description

25-Week Objective Response Rate (ORR) by Blinded Independent Review Committee (BIRC) based on Tumor Volume Score (TVS), Mean change from baseline in Range of Motion (ROM) of the affected joint at Week 25., Mean change from baseline in the Worst Stiffness Numeric Rating Scale (NRS) score at Week 25, Mean change from baseline in the Worst Pain Numeric Rating Scale (NRS) score at Week 25, Mean change from baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Functioning score at Week 25, Mean change from baseline in EuroQol visual analogue scale (VAS) score at Week 25, Duration of Response (DOR) by Blinded Independent Review Committee based on RECIST 1.1., Duration of Response (DOR) by Blinded Independent Review Committee based on Tumor Volume Score (TVS).

Related papers

No related papers found yet.

Interventions

DRUGPlacebo

DRUGABSK021

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
25-Week Objective Response Rate (ORR) by Blinded Independent Review Committee (BIRC) based on RECIST 1.1.	—

Secondary

Measure	Time frame
25-Week Objective Response Rate (ORR) by Blinded Independent Review Committee (BIRC) based on Tumor Volume Score (TVS), Mean change from baseline in Range of Motion (ROM) of the affected joint at Week 25., Mean change from baseline in the Worst Stiffness Numeric Rating Scale (NRS) score at Week 25, Mean change from baseline in the Worst Pain Numeric Rating Scale (NRS) score at Week 25, Mean change from baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Functioning score at Week 25, Mean change from baseline in EuroQol visual analogue scale (VAS) score at Week 25, Duration of Response (DOR) by Blinded Independent Review Committee based on RECIST 1.1., Duration of Response (DOR) by Blinded Independent Review Committee based on Tumor Volume Score (TVS).	—

Measure

Time frame

25-Week Objective Response Rate (ORR) by Blinded Independent Review Committee (BIRC) based on Tumor Volume Score (TVS), Mean change from baseline in Range of Motion (ROM) of the affected joint at Week 25., Mean change from baseline in the Worst Stiffness Numeric Rating Scale (NRS) score at Week 25, Mean change from baseline in the Worst Pain Numeric Rating Scale (NRS) score at Week 25, Mean change from baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Functioning score at Week 25, Mean change from baseline in EuroQol visual analogue scale (VAS) score at Week 25, Duration of Response (DOR) by Blinded Independent Review Committee based on RECIST 1.1., Duration of Response (DOR) by Blinded Independent Review Committee based on Tumor Volume Score (TVS).

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Countries

France, Italy, Netherlands, Poland, Spain

Outcome results

None listed