Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of… (NCT04340843) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma
United States19 participantsStarted 2020-09-08
Plain-language summary
This phase II trial studies the effect of belinostat and SGI-110 (guadecitabine) or ASTX727 in treating patients with conventional chondrosarcoma that cannot be removed by surgery (unresectable) and has spread from where it first started (primary site) to other places in the body (metastatic). Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as guadecitabine and ASTX727, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving belinostat in combination with guadecitabine or ASTX727 may lower the chance of unresectable and metastatic chondrosarcoma growing or spreading.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have biopsy-proven conventional chondrosarcoma (CS) which is:
* Either metastatic or locally advanced and unresectable, and
* Measurable at study entry according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, and
* Amenable to biopsy with imaging guidance at no or acceptable risk to the patient as defined by institutional guidelines for research-related biopsies or the treating investigator's assessment
* In addition, the following criteria must be met:
* Patients must have at least one lesion measurable by RECIST version 1.1 criteria which has not been previously irradiated
* Patients who have histologic evidence of grade 1 chondrosarcoma only must either be symptomatic from their disease in the opinion of the treating investigator or demonstrate radiographic evidence of disease progression in the 3 months prior to initiation of study treatment
* Note: Pathology review and confirmation of diagnosis will occur at the site enrolling the patient on this study
* Patients may have been treated with any number of prior systemic therapies. Because there are no Food and Drug Administration (FDA)-approved treatments for this disease, patients who have received no prior systemic therapy are also eligible. However, disease must be deemed surgically unresectable
* Age \>= 18 years. Chondrosarcoma is rarely encountered in children and adolescents
* Eastern Cooperative Oncology Group (ECOG) performanc…
What they're measuring
1
Objective Response Rate (ORR) in Belinostat, ASTX727
Timeframe: Within 6 months after initiating study treatment