BTX-A51 in Patients With Liposarcoma or CIC-rearranged Sarcoma (NCT06414434) | Clinical Trial Compass
Active — Not RecruitingPhase 1
BTX-A51 in Patients With Liposarcoma or CIC-rearranged Sarcoma
United States24 participantsStarted 2024-09-30
Plain-language summary
This study is testing two different doses of BTX-A51 to determine if it is safe and tolerable in participants with liposarcoma with MDM2 amplification, myxoid liposarcoma, and CIC-rearranged sarcoma.
The name of the study drug used in this research study is:
-BTX-A51 (a type of kinase inhibitor)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Study participants must have histologically-confirmed metastatic and/or recurrent liposarcoma (limited to the subtypes of well-differentiated and/or dedifferentiated liposarcoma, which are associated with MDM2 amplifications), or myxoid liposarcoma, or CIC-rearranged sarcoma.
* ECOG performance status ≤2
* Adequate organ and marrow function as defined by the following metrics resulted within 7 days of study enrollment:
* WBC \>3000/mm3
* Platelets \>75,000μl
* ANC \>1500μl
* Hgb \>9g/dl
* Creatinine \<1.5 x ULN or measured CrCl of \>60ml/m2/1.73 m2
* Total bilirubin \<2 x ULN
* AST/ALT \<3 x ULN
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as
≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.
* Patients must have recovered from toxicity related to prior therapy to grade \<=1 (defined by CTCAE v5.0) (except alopecia and neuropathy, or immunotherapy related hypothyroidism)
* As the effect of this study drug on the developing human fetus is not known, women of child-bearing potential and men must agree to use at least 2 methods of contraception (abstinence; hormonal or barrier method of birth control) for the study and at least 2 month…
What they're measuring
1
Number of participants with adverse events, with laboratory abnormalities, with dose modifications, delays, interruptions, or premature discontinuation of BTX-A51 due to an adverse event
Timeframe: All AEs will be recorded from the time the subject signs informed consent until 30 days after the last dose of study BTX-A51.