MANEUVER: Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor

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

Agents: Pimicotinib (ABSK021)
Phase III
Status Recruiting
Sponsor Abbisko Therapeutics Co, Ltd

 

For further information please also consult ClinicalTrials.gov.

 

This is a Phase III Study of ABSK021 to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor

WHO is the trial for?

  • Patients of 18 years or older
  • Confirmed diagnosis of Tenosynovial Giant Cell Tumor (TGCT) which is not operable
  • Presence of at least one lesion of ≥ 2 cm
  • Overall health must be good (ECOG 0 or 1)

Patients cannot enter this trial if they:

  • had major surgery or previous anti-tumor therapy for TGCT within 4 weeks prior to randomization.
  • have additional malignancies requiring active treatment
  • had previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R such as pexidartinib.

WHAT is the key question that this trial is attempting to answer?

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.

WHY patients might want to participate?

Participation in this clinical trial provides patients with the opportunity to potentially benefit from a novel treatment, contribute to medical research, and play a role in advancing the understanding of Pimicotinib in the context of Tenosynovial Giant Cell Tumor.

WHEN will the trial be open?

This study is open for recruitment.

WHERE is the trial available?

The trial is being conducted in the US, Canada, China, the Netherlands, Italy, Poland and Spain. Further sites are planned to open soon.

For further information please check here.

Contact: YUAN LU
Email Address: clinical@abbisko.cn

STUDY DESIGN: What does the study look like?

This study consists of part 1 and part 2.

Part 1 is double-blinded (neither patient nor doctor know which treatment is given). Eligible patients will be randomized (randomly chosen by computer) to the pimicotinib (ABSK021) treatment group or the placebo group. All patients will stay on this treatment until the completion of part 1 (24 weeks). If eligible, all patients will move on to part 2. Patients on placebo will then cross over to the pimicotinib arm.

Part 2 is an open-label treatment phase (doctors and patients know what treatment is given). All patients will receive pimicotinib (ABSK021) until completion of 24 weeks of dosing or withdrawal from the study.

Pimicotinib is given orally (by mouth) at a dosage of 50mg daily. Patients do not need to be hospitalized to participate.

HOW do I get more information?

ClinicalTrials.gov, cancer societies or cancer focused patient advocacy groups in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations that might be helpful. If there are no such organization in your country, please email us for
more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken