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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05804045
Other study ID # ABSK021-301
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 27, 2023
Est. completion date June 2028

Study information

Verified date April 2024
Source Abbisko Therapeutics Co, Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT). The main questions it aims to answer are: - Whether the Pimicotinib(ABSK021) works well in patients with TGCT. - Whether the Pimicotinib(ABSK021) is safe in patients with TGCT. Participants will be asked to complete the study procedures: - Receive the administration of Pimicotinib(ABSK021) or placebo (a placebo is a look-alike substance that contains no active drug) about 24 weeks in study part 1. - Receive the administration of Pimicotinib(ABSK021) about 24 weeks in study part 2. - Receive the administration of Pimicotinib(ABSK021) till study end in study part 3. - Complete the study procedures speficied in the protocol, which is guided by researchers.


Description:

This study consists of part 1 and part 2. Part 1 is a double-blind phase, eligible patients will be randomized to Pimicotinib(ABSK021) treatment group or matching placebo group and will receive Pimicotinib(ABSK021) or matching placebo until completion of Part 1. Part 2 is an open-label treatment phase, and all patients entering this phase will receive open-label Pimicotinib(ABSK021) until completion of 24 weeks of dosing or withdrawal from the study. Part 3 is an open-label extension treatment phase, and patients who completed the part 2 and continuted to be eligible, will go to the Part 3. Patients will receive the open-label Pimicotinib(ABSK021) until all patients withdraw from the study, or the sponsor decides to terminate the study, whichever occurs first.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date June 2028
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients should understand the study procedures and sign the informed consent form prior to screening. - Age = 18 years. - A histologically confirmed TGCT with unresectable. - Measurable disease as defined by RECIST 1.1, and with at least one lesion of = 2 cm. - Stable prescription of analgesic regimen for patients with an analgesic need. - 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. - ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1. - Adequate organ function and bone marrow function. Exclusion Criteria: - Known allergy or hypersensitivity to any components of the investigational drug product. - Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R. Previous therapy with imatinib and nilotinib is allowed. - 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. - Significant concomitant arthropathy in the affected joint, serious disease, uncontrolled infection. - Known MRI contraindications. - Has factors that significantly affected the absorption of oral drug. - Major surgery or previous anti-tumor therapy for TGCT within 4 weeks prior to randomization. - Concomitant use of strong CYP inhibitors or inducers as outlined in study protocol. - Impaired cardiac function or clinically significant cardiac disease. - Known active human immunodeficiency virus, active hepatitis B, active hepatitis C, or known active tuberculosis. - Known active liver or biliary disease, or other diseases that may lead to abnormal liver function test results during the study. - Pregnant or lactating women. - Childbearing potential males or non-surgically sterilized female patients must agree to use effective methods of contraception during the study. - Any other clinically significant comorbidities, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pimicotinib(ABSK021)
capsule
Placebo
capsule

Locations

Country Name City State
Canada McGill University Health Center Montréal
Canada Princess Margaret Cancer Center Toronto
China Beijing Jishuitan Hospital Beijing
China Peking University People's Hospital Beijing Beijing
China The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
China Hunan Provincial People's Hospital Changsha Hunan
China The Second Xiangya Hospital of Central South University Changsha Hunan
China West China Hospital Sichuan University Chengdu Wuhan
China The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture Enshi Hubei
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China The First Affiliated Hospital of Jinan University Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
China The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
China The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Nanjing Drum Tower hospital Nanjing Jiangsu
China Shanghai General Hospital Shanghai Shanghai
China Liaoning Cancer Hospital&Institute Shenyang Liaoning
China The Second Hospital of Shanxi Medical University Taiyuan Shanxi
China The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang
China Weifang People's Hospital Weifang Shandong
China Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China Xi'an Honghui Hospital Xi'an Shanxi
China Henan Cancer Hospital Zhengzhou Henan
Italy IRCCS Istituto Ortopedico Rizzoli Bologna
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Italy Ospedale di Prato Prato
Netherlands Leiden University Medical Center Leiden
Poland Maria Sklodowska-Curie National Research Institute of Oncology Warsaw
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Fundacion Jimenez Diaz Madrid
United States Precision NextGen Oncology Beverly Hills California
United States The Cleveland Clinic Foundation Cleveland Ohio
United States The Ohio State University Columbus Ohio
United States Henry Ford Health System Detroit Michigan
United States The University of Texas M.D. Anderson Cancer Center Houston Texas
United States Fred Hutchinson Cancer Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Abbisko Therapeutics Co, Ltd

Countries where clinical trial is conducted

United States,  Canada,  China,  Italy,  Netherlands,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) Assessed by central read using Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) Baseline to Week 25
Secondary Objective Response Rate (ORR) per Tumor Volume Score (TVS) Assessed by central read using Tumor Volume Score (TVS). TVS is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. Baseline to Week 25
Secondary Range of Motion (ROM) Mean change from baseline in ROM of the affected joint Baseline to Week 25
Secondary Worst Stiffness Mean change from baseline in the Worst Stiffness Numeric Rating Scale (NRS) score at Week 25. The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine). Higher scores mean a worse outcomes. Baseline to Week 25
Secondary Worst Pain Mean change from baseline in the Worst Pain Numeric Rating Scale (NRS) score at Week 25. The Worst Pain Numeric Rating Scale Score (NRS) was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores mean a worse outcomes. Baseline to Week 25
Secondary Physical Function Mean change from baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function score at Week 25. The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes. Baseline to Week 25
Secondary Quality of life (QoL) Mean change from baseline in EuroQol visual analogue scale (VAS) score at Week 25. The EuroQol visual analogue scale (VAS) is a Visual Analogue Scale on which the patient rates their current health, with 0 representing the "worst health you can imagine" and 100 representing the "best health you can imagine". Higher scores mean a better outcomes. Baseline to Week 25
Secondary Duration of Response (DOR) Duration of Response as measured by RECIST Version 1.1 and Tumor Volume Score (TVS) The time (months) from the first documentation of objective response to the first documentation of radiographic disease progression (PD) or death due to any cause, whichever occurs first, assessed up to 24 months.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04488822 - A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT Phase 3
Active, not recruiting NCT01207492 - Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor Phase 2
Terminated NCT04938180 - A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients Phase 2
Completed NCT04526704 - Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib Phase 4
Active, not recruiting NCT05059262 - Study of Vimseltinib for Tenosynovial Giant Cell Tumor Phase 3
Active, not recruiting NCT04731675 - An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee Phase 2
Completed NCT02371369 - Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) Phase 3
Recruiting NCT04703322 - A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan Phase 2
Completed NCT02471716 - Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor Phase 1/Phase 2
Recruiting NCT04635111 - A Long-term Study Evaluating Hepatotoxicity Associated With TURALIOâ„¢ (Pexidartinib) Treatment
Recruiting NCT05349643 - A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT Phase 2
Recruiting NCT04192344 - A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor Phase 1
Terminated NCT02673736 - A Study of PLX73086 in Advanced Solid Tumors and Locally Advanced or Refractory Tenosynovial Giant Cell Tumor Phase 1
Active, not recruiting NCT03069469 - Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor Phase 1/Phase 2
Terminated NCT01804530 - Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors Phase 1