Tazemetostat in Malignant Peripheral Nerve Sheath Tumors
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|ClinicalTrials.gov Identifier: NCT04917042|
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : August 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Nerve Sheath Tumor||Drug: Tazemetostat||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study Using Tazemetostat in Patients With Recurrent/Refractory and/or Metastatic Malignant Peripheral Nerve Sheath Tumors (MPNST)|
|Estimated Study Start Date :||September 2021|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2024|
Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
Other Name: TAZVERIK
- Objective response rate [ Time Frame: 2 years ]Assess the objective response rate, defined as the proportion of subjects who achieve either a complete response or partial response based on radiographic evaluation of treatment response via RECIST1.1
- Progression free survival [ Time Frame: 3 years ]Determine the progression free survival, defined as the length of time from the start of treatment to time of progression or death, whichever occurs first.
- Time to progression [ Time Frame: 2 years ]Determine the time to progression, defined as the length of time from the start of treatment until disease progression by RECIST 1.1 criteria.
- Clinical benefit [ Time Frame: 2 years ]Determine the clinical benefit using the Numbered Pain Rating Scale. A person rates their pain on a scale of 0 to 10 or 0 to 5. Zero means "no pain," and 5 or 10 means "the worst possible pain." These pain intensity levels may be assessed upon initial treatment, or periodically after treatment.
- Clinical benefit rate [ Time Frame: 2 years ]Assess the clinical benefit rate, defined as the proportion of subjects with complete or partial response or stable disease (by RECIST 1.1 criteria) lasting at least 4 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04917042
|Contact: Abigail Masterson||(352) 294-8322||PMO@cancer.ufl.edu|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32608|
|Contact: Ashley Bayne 352-294-8745 email@example.com|
|Principal Investigator: Joanne Lagmay, MD|
|Principal Investigator:||Joanne Lagmay, MD||University of Florida|