Trial Title:
Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
NCT ID:
NCT05804045
Condition:
Tenosynovial Giant Cell Tumor
Pigmented Villonodular Synovitis
Giant Cell Tumor of Tendon Sheath
Conditions: Official terms:
Neoplasms
Giant Cell Tumors
Giant Cell Tumor of Tendon Sheath
Synovitis, Pigmented Villonodular
Synovitis
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Pimicotinib(ABSK021)
Description:
capsule
Arm group label:
Part 1- Placebo/ Pimicotinib(ABSK021)
Arm group label:
Part 1/Part 2/Part 3- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)
Intervention type:
Drug
Intervention name:
Placebo
Description:
capsule
Arm group label:
Part 1- Placebo/ Pimicotinib(ABSK021)
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.
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Precision NextGen Oncology
Address:
City:
Beverly Hills
Zip:
90212
Country:
United States
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Facility:
Name:
The Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Facility:
Name:
The Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
The University of Texas M.D. Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Facility:
Name:
McGill University Health Center
Address:
City:
Montréal
Country:
Canada
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Country:
Canada
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Country:
China
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Facility:
Name:
The First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Country:
China
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Facility:
Name:
The First Affiliated Hospital of Jinan University
Address:
City:
Guangzhou
Country:
China
Facility:
Name:
The First Affiliated Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Facility:
Name:
The Affiliated Hospital of Guizhou Medical University
Address:
City:
Guiyang
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Facility:
Name:
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Address:
City:
Enshi
Country:
China
Facility:
Name:
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Facility:
Name:
Hunan Provincial People's Hospital
Address:
City:
Changsha
Country:
China
Facility:
Name:
The Second Xiangya Hospital of Central South University
Address:
City:
Changsha
Country:
China
Facility:
Name:
Nanjing Drum Tower hospital
Address:
City:
Nanjing
Country:
China
Facility:
Name:
Liaoning Cancer Hospital&Institute
Address:
City:
Shenyang
Country:
China
Facility:
Name:
Weifang People's Hospital
Address:
City:
Weifang
Country:
China
Facility:
Name:
Shanghai General Hospital
Address:
City:
Shanghai
Country:
China
Facility:
Name:
The Second Hospital of Shanxi Medical University
Address:
City:
Taiyuan
Country:
China
Facility:
Name:
Xi'an Honghui Hospital
Address:
City:
Xi'an
Country:
China
Facility:
Name:
West China Hospital Sichuan University
Address:
City:
Chengdu
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xinjiang Medical University
Address:
City:
Ürümqi
Country:
China
Facility:
Name:
The Second Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Facility:
Name:
Beijing Jishuitan Hospital
Address:
City:
Beijing
Country:
China
Facility:
Name:
IRCCS Istituto Ortopedico Rizzoli
Address:
City:
Bologna
Country:
Italy
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Country:
Italy
Facility:
Name:
Ospedale di Prato
Address:
City:
Prato
Country:
Italy
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2333
Country:
Netherlands
Facility:
Name:
Maria Sklodowska-Curie National Research Institute of Oncology
Address:
City:
Warsaw
Country:
Poland
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Country:
Spain
Facility:
Name:
Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Start date:
April 27, 2023
Completion date:
June 2028
Lead sponsor:
Agency:
Abbisko Therapeutics Co, Ltd
Agency class:
Industry
Source:
Abbisko Therapeutics Co, Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05804045
