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Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)

Primary Purpose

Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimicotinib(ABSK021)
Placebo
Sponsored by
Abbisko Therapeutics Co, Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tenosynovial Giant Cell Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Precision NextGen OncologyRecruiting
  • The Cleveland Clinic FoundationRecruiting
  • The University of Texas M.D. Anderson Cancer CenterRecruiting
  • Fred Hutchinson Cancer CenterRecruiting
  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • Peking University People's HospitalRecruiting
  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • The First Affiliated Hospital of Jinan UniversityRecruiting
  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • The Affiliated Hospital of Guizhou Medical UniversityRecruiting
  • Henan Cancer HospitalRecruiting
  • The Central Hospital of Enshi Tujia and Miao Autonomous PrefectureRecruiting
  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Hunan Provincial People's HospitalRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Nanjing Drum Tower hospitalRecruiting
  • Liaoning Cancer Hospital&InstituteRecruiting
  • Weifang People's HospitalRecruiting
  • Shanghai General HospitalRecruiting
  • The Second Hospital of Shanxi Medical UniversityRecruiting
  • Xi'an Honghui HospitalRecruiting
  • West China Hospital Sichuan UniversityRecruiting
  • The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
  • The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Beijing Jishuitan HospitalRecruiting
  • Fundacion Jimenez DiazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Part 1/Part 2- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)

Part 1/Part 2- Placebo/ Pimicotinib(ABSK021)

Arm Description

Participants receive the blinded treatment of ABSK021 for 24 weeks in Part 1 and continue on the open-label Pimicotinib(ABSK021) in Part 2.

Participants receive the blinded treatment of matching placebo for 24 weeks in Part 1 and have option to receive the open-label Pimicotinib(ABSK021) in Part 2.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
Assessed by central read using Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

Secondary Outcome Measures

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.
Range of Motion (ROM)
Mean change from baseline in ROM of the affected joint
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.
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.
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.
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.
Duration of Response (DOR)
Duration of Response as measured by RECIST Version 1.1 and Tumor Volume Score (TVS)

Full Information

First Posted
March 13, 2023
Last Updated
October 16, 2023
Sponsor
Abbisko Therapeutics Co, Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05804045
Brief Title
Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbisko Therapeutics Co, Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. Complete the study procedures speficied in the protocol, which is guided by researchers.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1/Part 2- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)
Arm Type
Experimental
Arm Description
Participants receive the blinded treatment of ABSK021 for 24 weeks in Part 1 and continue on the open-label Pimicotinib(ABSK021) in Part 2.
Arm Title
Part 1/Part 2- Placebo/ Pimicotinib(ABSK021)
Arm Type
Placebo Comparator
Arm Description
Participants receive the blinded treatment of matching placebo for 24 weeks in Part 1 and have option to receive the open-label Pimicotinib(ABSK021) in Part 2.
Intervention Type
Drug
Intervention Name(s)
Pimicotinib(ABSK021)
Intervention Description
capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsule
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Assessed by central read using Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Time Frame
Baseline to Week 25
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) per Tumor Volume Score (TVS)
Description
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.
Time Frame
Baseline to Week 25
Title
Range of Motion (ROM)
Description
Mean change from baseline in ROM of the affected joint
Time Frame
Baseline to Week 25
Title
Worst Stiffness
Description
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.
Time Frame
Baseline to Week 25
Title
Worst Pain
Description
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.
Time Frame
Baseline to Week 25
Title
Physical Function
Description
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.
Time Frame
Baseline to Week 25
Title
Quality of life (QoL)
Description
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.
Time Frame
Baseline to Week 25
Title
Duration of Response (DOR)
Description
Duration of Response as measured by RECIST Version 1.1 and Tumor Volume Score (TVS)
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YUAN LU
Phone
+86-21-68910052
Email
clinical@abbisko.cn
Facility Information:
Facility Name
Precision NextGen Oncology
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamlesh Sankhala
First Name & Middle Initial & Last Name & Degree
Kamlesh Sankhala
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dale Shepard
First Name & Middle Initial & Last Name & Degree
Dale Shepard, PhD
Facility Name
The University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinod Ravi
First Name & Middle Initial & Last Name & Degree
Vinod Ravi, M.D.
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Loggers
First Name & Middle Initial & Last Name & Degree
Elizabeth Loggers, Ph.D
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Chen
First Name & Middle Initial & Last Name & Degree
Xiaodong Chen
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Guo
First Name & Middle Initial & Last Name & Degree
Wei Guo
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Zhu
First Name & Middle Initial & Last Name & Degree
Xia Zhu
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Zhang
First Name & Middle Initial & Last Name & Degree
Yu Zhang
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gehui Hou
First Name & Middle Initial & Last Name & Degree
Gehui Hou
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingnan Shen
First Name & Middle Initial & Last Name & Degree
Jingnan Shen
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuan Ye
First Name & Middle Initial & Last Name & Degree
Chuan Ye
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weitao Yao
First Name & Middle Initial & Last Name & Degree
Weitao Yao
Facility Name
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
City
Enshi
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Lai
First Name & Middle Initial & Last Name & Degree
Lin Lai
Facility Name
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongtao Tian
First Name & Middle Initial & Last Name & Degree
Hongtao Tian
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Wang
First Name & Middle Initial & Last Name & Degree
Jing Wang
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tang Liu
First Name & Middle Initial & Last Name & Degree
Tang Liu
Facility Name
Nanjing Drum Tower hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoufeng Wang
First Name & Middle Initial & Last Name & Degree
Shoufeng Wang
Facility Name
Liaoning Cancer Hospital&Institute
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojing Zhang
First Name & Middle Initial & Last Name & Degree
Xiaojing Zhang
Facility Name
Weifang People's Hospital
City
Weifang
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bingwu Wang
First Name & Middle Initial & Last Name & Degree
Bingwu Wang
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingqi Hua
First Name & Middle Initial & Last Name & Degree
Yingqi Hua
Facility Name
The Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Feng
First Name & Middle Initial & Last Name & Degree
Yi Feng
Facility Name
Xi'an Honghui Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhichao Tong
First Name & Middle Initial & Last Name & Degree
Zhichao Tong
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Zhou
First Name & Middle Initial & Last Name & Degree
Yong Zhou
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Tian
First Name & Middle Initial & Last Name & Degree
Zheng Tian
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaoming Ye
First Name & Middle Initial & Last Name & Degree
Zhaoming Ye
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Li
First Name & Middle Initial & Last Name & Degree
Tao Li
Facility Name
Beijing Jishuitan Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohui Niu
First Name & Middle Initial & Last Name & Degree
Xiaohui Niu
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Martin-Broto
First Name & Middle Initial & Last Name & Degree
Javier Martin-Broto

12. IPD Sharing Statement

Learn more about this trial

Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)

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