NCT04340843|Active Not RecruitingPhase 2ResultsFDA Drug

Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma

A Phase 2 Study of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2020-0218710330UM1CA186686

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredApr 2020

StartedSep 2020

CompletionJan 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

9mo left

Started Sep 2020

Longer than P75 for phase_2

Geographic Reach

1 country

39 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.4 years study duration

Study Progress89%

Sep 2020Jan 2027

First Submitted

Initial submission to the registry

April 9, 2020

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed

5 months until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2024

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

September 16, 2025

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2027

Expected

Last Updated

April 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

April 9, 2020

Results QC Date

August 11, 2025

Last Update Submit

April 9, 2026

Conditions

Unresectable Primary Central Chondrosarcoma Locally Advanced Unresectable Primary Central Chondrosarcoma Metastatic Primary Central Chondrosarcoma

Outcome Measures

Primary Outcomes (1)

Objective Response Rate (ORR) in Belinostat, ASTX727
Best Objective Response per RECIST Version 1.1 criteria. CR, complete response defined by the disappearance of all target lesions; PR, partial response defined by at least a 30% decrease in the sum of the diameters of target lesions; SD, stable disease defined by neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; PD, progressive disease defined by at least a 20% increase in the sum of the diameters of target lesions or the appearance of one or more new lesions.
Within 6 months after initiating study treatment

Secondary Outcomes (5)

Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Up to 24 months post treatment
Progression Free Survival (PFS) in Belinostat, ASTX727
Time from first treatment with the study drug to the earliest of either disease progression or death from any cause, assessed up to 24 months.
Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110
Up to 24 months post treatment
Progression Free Survival (PFS) in Belinostat, SGI-110
Time from first treatment with the study drug to the earliest of either disease progression or death from any cause, assessed up to 24 months.
Objective Response Rate (ORR) in Belinostat, SGI-110
Within 6 months after initiating study treatment.

Other Outcomes (4)

IDH1/2 Mutational Status
Up to 24 months post treatment
Changes in Expression of Conventional Chondrosarcoma Genes
Baseline up to 24 months post treatment
Changes in Global Deoxyribonucleic Acid Methylation
Baseline up to 24 months post treatment
+1 more other outcomes

Study Arms (1)

Treatment (belinostat, guadecitabine, ASTX727)

EXPERIMENTAL

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.

Drug: BelinostatProcedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyDrug: Decitabine and CedazuridineDrug: GuadecitabineProcedure: Magnetic Resonance Imaging

Interventions

Decitabine and CedazuridineDRUG

Given PO

Also known as: ASTX 727, ASTX-727, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inaqovi, Inqovi