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Tyrosine Kinase Inhibitor
Pimicotinib for Giant Cell Tumor
Phase 3
Waitlist Available
Research Sponsored by Abbisko Therapeutics Co, Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Study Summary
This trial will evaluate the effectiveness and safety of Pimicotinib(ABSK021) to treat Tenosynovial Giant Cell Tumor.
Who is the study for?
Adults over 18 with a confirmed diagnosis of Tenosynovial Giant Cell Tumor (TGCT) that can't be surgically removed and have at least one measurable lesion. They must understand the study, sign consent, have stable pain medication needs, adequate organ and bone marrow function, and an ECOG performance status of 0 or 1.Check my eligibility
What is being tested?
The trial is testing Pimicotinib (ABSK021), comparing it to a placebo to see if it's effective and safe for TGCT patients. Part one lasts about 24 weeks with either Pimicotinib or placebo; part two continues with Pimicotinib for another 24 weeks.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the drug components, issues related to oral absorption affecting digestion, changes in liver function tests indicating liver health concerns, as well as general risks associated with taking new medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Objective Response Rate (ORR) per Tumor Volume Score (TVS)
Physical Function
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 1/Part 2/Part 3- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)Experimental Treatment1 Intervention
Participants receive the blinded treatment of ABSK021 for 24 weeks in Part 1 and continue on the open-label Pimicotinib(ABSK021) in Part 2 and Part 3.
Group II: Part 1- Placebo/ Pimicotinib(ABSK021)Placebo Group2 Interventions
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.
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Who is running the clinical trial?
Abbisko Therapeutics Co, LtdLead Sponsor
18 Previous Clinical Trials
1,213 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.I have been treated with specific inhibitors but not those targeting CSF-1/CSF-1R, except imatinib and nilotinib are okay.I am not taking any strong medications that affect liver enzymes as listed in the study.My cancer has spread beyond the original site.I haven't had major surgery or cancer treatment for TGCT in the last 4 weeks.I have heart problems that affect my daily activities.I do not have active HIV, hepatitis B, hepatitis C, or tuberculosis.I have a liver condition that could affect my liver test results.My pain medication dose has been stable.I have another cancer that is being treated and could interfere with this study.I agree to use birth control during the study.I have conditions that affect how my body absorbs pills.My organs and bone marrow are working well.My tumor is confirmed TGCT, cannot be surgically removed, and has a lesion over 2 cm.I do not have severe joint problems, serious illnesses, or uncontrolled infections.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1- Placebo/ Pimicotinib(ABSK021)
- Group 2: Part 1/Part 2/Part 3- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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