Belinostat + Guadecitabine/ASTX727 for Chondrosarcoma

Recruiting in Palo Alto (17 mi)

+43 other locations

Overseen byMia Weiss

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mia Weiss

Principal Investigator

Yale University Cancer Center LAO

Eligibility Criteria

This trial is for adults (18+) with a type of bone cancer called conventional chondrosarcoma that can't be surgically removed and has spread. Participants must have at least one measurable tumor, may have had any number of prior treatments or none, but their disease should not be treatable by surgery. They need to be in fair health overall (ECOG <=2) and able to undergo biopsy.

Inclusion Criteria

My cancer diagnosis will be reviewed at the study site.

I have a tumor that can be measured and hasn't been treated with radiation.

I can safely undergo a biopsy as per my doctor's assessment.

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Treatment Details

Interventions

ASTX727 (DNA Methyltransferase Inhibitor)
Belinostat (Histone Deacetylase Inhibitor)
Guadecitabine (DNA Methyltransferase Inhibitor)

Trial OverviewThe study tests belinostat combined with either guadecitabine or ASTX727 on patients with advanced chondrosarcoma. Belinostat blocks enzymes needed for cell growth; guadecitabine and ASTX727 are chemotherapy drugs aiming to kill or stop the spread of cancer cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (belinostat, guadecitabine, ASTX727)Experimental Treatment7 Interventions

Patients receive guadecitabine SC or ASTX727 PO on days 1-5. Patients also receive belinostat IV over 30 minutes on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood during screening, tumor biopsy during screening and on study, and MRI or CT throughout the trial.