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DNA Methyltransferase Inhibitor

Belinostat + Guadecitabine/ASTX727 for Chondrosarcoma

Phase 2
Waitlist Available
Led By Matthew Ingham
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have at least one lesion measurable by RECIST version 1.1 criteria which has not been previously irradiated
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post treatment
Awards & highlights

Summary

This trial is studying the effect of belinostat and SGI-110 (guadecitabine) or ASTX727 in treating patients with conventional chondrosarcoma.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects include reactions related to the immune system's response, fatigue, nausea, liver issues due to enzyme inhibition, and complications from chemotherapy such as low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be measured and hasn't been treated with radiation.
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I can take care of myself but may not be able to do heavy physical work.
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My cancer has spread or cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate
Secondary outcome measures
Occurrence of dose limiting toxicity (DLT)
Presence of treatment related adverse events (AEs)
Progression free survival (PFS)
Other outcome measures
Changes in expression of conventional chondrosarcoma genes
Changes in global deoxyribonucleic acid methylation
Changes in tumor microenvironment
+1 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Guadecitabine
2014
Completed Phase 3
~570
Biospecimen Collection
2004
Completed Phase 2
~1720
Biopsy
2014
Completed Phase 4
~1090
Belinostat
2006
Completed Phase 2
~430
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,369 Total Patients Enrolled
Matthew InghamPrincipal InvestigatorYale University Cancer Center LAO
3 Previous Clinical Trials
254 Total Patients Enrolled
Mia WeissPrincipal InvestigatorYale University Cancer Center LAO
~2 spots leftby Jan 2025
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