Liposarcoma Clinical Trial
Official title:
A Pilot Study of BTX-A51 in Patients With Metastatic and/or Recurrent Liposarcomas Characterized by MDM2 Amplifications
This study is testing if the recommended dose of BTX-A51 is safe and tolerable in participants with liposarcoma. The name of the study drug used in this research study is: -BTX-A51 (a type of kinase inhibitor)
Status | Not yet recruiting |
Enrollment | 12 |
Est. completion date | June 1, 2027 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). - 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 months after completion. - Female patient of childbearing potential has a negative serum pregnancy test within 7 days of study enrollment. - Ability to understand and the willingness to sign a written informed consent document. - Age =18 years - Patients must have completed all prior anti-cancer treatment for liposarcoma, including radiation, = 14 days prior to registration. Exclusion Criteria: - Patient with current evidence of active and uncontrolled infection, NYHA Class III-IV CHF, documented Child's class B-C cirrhosis, or uncontrolled medical disease which in the opinion of the investigator or the sponsor could compromise safety and/or assessment of efficacy. - Active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment; those who are PCR positive will be excluded. - Major surgical procedure or open surgical biopsy within 28 days of first dose of study drug - Active central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade =3 drug-related CNS toxicity. Subject with known CNS metastases that are treated and stable (without evidence of CNS toxicity) and are not requiring systemic steroids are allowed to be enrolled. - Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial - Myocardial infarction within 12 months of screening - Use of any other concurrent investigational agents or anticancer agents, excluding hormonal therapy for breast or prostate cancer - Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BTX- A51, breastfeeding should be discontinued if the mother is treated with BTX-A51. - Inability to swallow pills or inadequate GI absorption in the opinion of the treating investigator. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Michael Wagner | Edgewood Oncology Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Safety and tolerability will be monitored through continuous reporting of treatment-emergent and treatment-related adverse events, laboratory abnormalities, and incidence of subjects experiencing dose modifications, delays, interruptions, or premature discontinuation of BTX-A51 due to an adverse event. Toxicities are to be assessed according to the CTCAEv5. | All AEs will be recorded from the time the subject signs informed consent until 30 days after the last dose of study BTX-A51. | |
Secondary | Overall Response Rate (ORR) | The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria. | ORR expected to be observed up to 3 years | |
Secondary | 1-year Progression-Free Survival (PFS) Rate | 1-year PFS is a probability estimated using progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last disease assessment. | 1 year | |
Secondary | 1-year Overall Survival (OS) | 1-year OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive. | 1 year |
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