ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma (NCT05116683) | Clinical Trial Compass
TerminatedPhase 2
ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma
Stopped: Study terminated by PI
United States4 participantsStarted 2022-01-11
Plain-language summary
The purpose of this study is to evaluate the effectiveness of a new investigational drug, ATX-101, for the treatment of dedifferentiated liposarcoma (LPS) and leiomyosarcoma (LMS). ATX-101 is an intravenous (IV) drug which blocks the interaction of a protein called PCNA with a number of "stress response" proteins. These interactions are thought to be important for cancer cell survival and growth. ATX-101 may disrupt these interactions and therefore help treat the cancer. In this study, all patients will receive the same treatment. Most of the exams, tests, and procedures are part of the usual approach to medical care for this condition. However, some additional tests or procedures may be performed, and other tests may be performed more frequently than usual.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed dedifferentiated liposarcoma (LPS) or leiomyosarcoma
* ATX-101 in Sarcoma Phase II
* (LMS). Pathology review occurs at the center enrolling the patient on this trial.
* Disease must be locally advanced and unresectable or metastatic. Disease which may be resected but with an associated level of morbidity deemed unacceptable by the treating clinician is considered eligible.
* Patients must have measurable disease by RECIST criteria version 1.1. In addition, the first 10 patients enrolled on the study must have a site of disease amenable to image-guided biopsy at minimal risk or less, and must agree to undergo this biopsy.
* Patients must evidence of disease progression, either clinically or radiographically, within the 12 weeks prior to study enrollment, as determined by the investigator enrolling the patient on the study.
* Patients must have been treated with at least one prior systemic regimen for advanced sarcoma: LMS: Anthracycline-based chemotherapy, or gemcitabine/docetaxel. LPS: No specification as to the prior treatment received. Neoadjuvant or adjuvant systemic therapy does not qualify as prior treatment unless completed within 6 months of disease relapse.
* Patients must be age 18 years or older. Because the safety of ATX-101 in patients less than 18 years of age has not been characterized, children are excluded from the present study.
* Patients must demonstrate an Eastern Cooperative Oncology Group (ECOG) performance…