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Pimicotinib for Giant Cell Tumor
Study Summary
This trial will evaluate the effectiveness and safety of Pimicotinib(ABSK021) to treat Tenosynovial Giant Cell Tumor.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Part 1- Placebo/ Pimicotinib(ABSK021)
- Group 2: Part 1/Part 2/Part 3- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
Are there still available opportunities to participate in this research project?
"According to the data on clinicaltrials.gov, this medical experiment is presently recruiting participants. It was launched on April 27th 2023 and its most recent update occurred on May 17th of that same year."
How many participants are enrolled in this clinical investigation?
"Affirmative, research published on clinicaltrials.gov asserts that the trial is in need of participants and began recruitment as early as April 27th 2023. The study requires 90 enrollees to be accepted from two separate medical centres with updates being made most recently on May 17th 2023."
Is Pimicotinib(ABSK021) safe for human consumption?
"The safety of Part 1/Part 2- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021) was rated a 3 on the Power scale due to the abundance of evidence from Phase 3 clinical trials demonstrating its efficacy and multiple rounds confirming its security."
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