A clinical study of ABSK021 in Patients with Tenosynovial Giant Cell Tumor to determine whether the study drug is safe and how well the antitumor activity of study drug
- Conditions
- Tenosynovial Giant Cell TumorTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503245-58-00
- Lead Sponsor
- Abbisko Therapeutics Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 95
Patients should understand the study procedures and sign the informed consent form prior to screening, Age = 18 years, A histologically confirmed TGCT with not amenable to surgery prior to randomization., Measurable disease as defined by RECIST 1.1, and with at least one lesion of = 2 cm prior to randomization., Stable prescription of analgesic regimen for patients with an analgesic need during the 2 weeks prior to randomization., Participants should complete stiffness and pain scales during the screening period, and symptomatic disease because of active TGCT should meet minimum requirements as outlined in study protocol., Adequate organ function and bone marrow function.
Known allergy or hypersensitivity to any components of the investigational drug product, Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R prior to randomization. However, patients who have received prior treatment with multi-kinase inhibitors that include the CSF-1/CSF-1R pathway are allowed, such as Imatinib and otinib, Known additional malignancy that required active treatment and may affect the patient’s participation in the study or affect the outcome of the study as assessed by the Investigator, Known metastatic TGCT, Major surgery or previous anti-tumor therapy for TGCT within 4 weeks prior to randomization, or unhealed, infected, or dehiscence of previous surgical wounds, or adverse events from prior therapies did not recover to = Grade 1 (CTCAE 5.0)., Impaired cardiac function or clinically significant cardiac disease, Known active liver or biliary disease, or other diseases that may lead to abnormal liver function test results during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the Objective Response Rate (ORR) within 25 <br>weeks after treatment with ABSK021 or placebo in TGCT <br>patients based on RECIST 1.1.;Secondary Objective: To compare the Objective Response Rate (ORR) within 25 weeks after treatment with ABSK021 or placebo in TGCT patients based on Tumor Volume Score (TVS), To compare the effects of ABSK021 and placebo on the Range of Motion (ROM) in TGCT patients at Week 25, To compare the effects of ABSK021 and placebo on Patient Reported Outcome (PRO) in TGCT patients at Week 25., To compare the Duration of Response (DOR) after treatment with ABSK021 or placebo in TGCT patients based on RECIST 1.1 and TVS, respectively., To compare the safety of ABSK021 and placebo in TGCT patients, To evaluate the pharmacokinetic (PK) profile of oral ABSK021;Primary end point(s): 25-Week Objective Response Rate (ORR) by Blinded Independent Review Committee (BIRC) based on RECIST 1.1.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):25-Week Objective Response Rate (ORR) by Blinded Independent Review Committee (BIRC) based on Tumor Volume Score (TVS);Secondary end point(s):Mean change from baseline in Range of Motion (ROM) of the affected joint at Week 25.;Secondary end point(s):Mean change from baseline in the Worst Stiffness Numeric Rating Scale (NRS) score at Week 25;Secondary end point(s):Mean change from baseline in the Worst Pain Numeric Rating Scale (NRS) score at Week 25;Secondary end point(s):Mean change from baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Functioning score at Week 25;Secondary end point(s):Mean change from baseline in EuroQol visual analogue scale (VAS) score at Week 25;Secondary end point(s):Duration of Response (DOR) by Blinded Independent Review Committee based on RECIST 1.1.;Secondary end point(s):Duration of Response (DOR) by Blinded Independent Review Committee based on Tumor Volume Score (TVS).