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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Occurrence of dose limiting toxicity (DLT)

Presence of treatment related adverse events (AEs)

Progression free survival (PFS)

Other study objectives

Changes in expression of conventional chondrosarcoma genes

Changes in global deoxyribonucleic acid methylation

Changes in tumor microenvironment

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2740

Guadecitabine

2014

Completed Phase 3

~730