Trial · NCT04340843
Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma
NCT04340843, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma. Trials, record NCT04340843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04340843
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma
- NCT number
- NCT04340843
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Locally Advanced Unresectable Primary Central Chondrosarcoma, Metastatic Primary Central Chondrosarcoma, Unresectable Primary Central Chondrosarcoma
- Interventions
- Belinostat, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Decitabine and Cedazuridine, Guadecitabine, Magnetic Resonance Imaging
- First posted
- 2020-04-10
- Last updated
- 2026-09-08
- Results first posted
- 2025-09-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) in Belinostat, ASTX727 | Within 6 months after initiating study treatment | 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. |
| Secondary | Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727 | Up to 24 months post treatment | Adverse events (AEs) in belinostat, ASTX727 were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The attribution of AEs to each of the study drugs was recorded and categorized as possibly, probably, or definitely related to treatment. AEs are reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity. |
| Secondary | 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. | PFS is defined as the time from first treatment with the study drug to the earliest of either disease progression or death from any cause. Patients who are alive and progression free will be censored at the time of their last follow-up. The Kaplan-Meier method was used to evaluate time to event endpoints. Median PFS was reported with a 95% confidence interval. Data will be presented as Kaplan Meier plots. |
| Secondary | Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110 | Up to 24 months post treatment | Adverse events (AEs) from belinostat, SGI-110 were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The attribution of AEs to each of the study drugs was recorded and categorized as possibly, probably, or definitely related to treatment. AEs are reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity. |
| Secondary | 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. | PFS is defined as the time from first treatment with the study drug to the earliest of either disease progression or death from any cause. Patients who are alive and progression free will be censored at the time of their last follow-up. The Kaplan-Meier method was used to evaluate time to event endpoints. Median PFS was reported with a 95% confidence interval. Data will be presented as Kaplan Meier plots. |
| Secondary | Objective Response Rate (ORR) in Belinostat, SGI-110 | Within 6 months after initiating study treatment. | 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. |
| Other | IDH1/2 Mutational Status | Up to 24 months post treatment | Will compare the difference in the objective response rate among patients with IDH1/2 mutations as compared those without IDH1/2 mutations using Fisher's exact test. |
| Other | Changes in Expression of Conventional Chondrosarcoma Genes | Baseline up to 24 months post treatment | Data from ribonucleic acid sequencing will be analyzed. Differential expression profiles between baseline and on-treatment samples will be analyzed at the gene level and gene expression changes defined as significant based on absolute log2 fold changes \> 2 and adjusted p values \< 0.005 for each comparison with consideration of the false discovery rate. |
| Other | Changes in Global Deoxyribonucleic Acid Methylation | Baseline up to 24 months post treatment | A Wilcoxon signed-rank test with continuity correction will be used to calculate P values for comparing methylation level distribution at the different time points. |
| Other | Changes in Tumor Microenvironment | Baseline up to 24 months post treatment | For quantitative immune multiplexing, data is derived from inForm software, and changes in defined immune cell subsets and expression between baseline and on-treatment samples will be assessed using paired T-tests. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) in Belinostat, ASTX727 | Within 6 months after initiating study treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727 | Up to 24 months post treatment | Treatment-Related Adverse Events Occurring in \> 20% of patients treated with belinostat, ASTX727 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | months | MEDIAN | |
| SECONDARY | Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110 | Up to 24 months post treatment | Treatment-Related Adverse Events Occurring in \> 20% of patients treated with belinostat, SGI-110 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | months | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) in Belinostat, SGI-110 | Within 6 months after initiating study treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | IDH1/2 Mutational Status | Up to 24 months post treatment | |||
| OTHER_PRE_SPECIFIED | Changes in Expression of Conventional Chondrosarcoma Genes | Baseline up to 24 months post treatment | |||
| OTHER_PRE_SPECIFIED | Changes in Global Deoxyribonucleic Acid Methylation | Baseline up to 24 months post treatment | |||
| OTHER_PRE_SPECIFIED | Changes in Tumor Microenvironment | Baseline up to 24 months post treatment |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) in Belinostat, ASTX727 | Treatment (Belinostat, ASTX727) | CR/PR | 0 | Participants | |
| Objective Response Rate (ORR) in Belinostat, ASTX727 | Treatment (Belinostat, ASTX727) | SD | 6 | Participants | |
| Objective Response Rate (ORR) in Belinostat, ASTX727 | Treatment (Belinostat, ASTX727) | PD | 4 | Participants | |
| Objective Response Rate (ORR) in Belinostat, ASTX727 | Treatment (Belinostat, ASTX727) | Not Evaluable | 3 | Participants | |
| Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727 | Treatment (Belinostat, ASTX727) | Nausea (Grades 1-2) | 9 | Participants | |
| Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727 | Treatment (Belinostat, ASTX727) | Leukopenia (Grades 1-2) | 5 | Participants | |
| Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727 | Treatment (Belinostat, ASTX727) | Leukopenia (Grades 3-4) | 3 | Participants | |
| Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727 | Treatment (Belinostat, ASTX727) | Neutropenia (Grades 1-2) | 1 | Participants | |
| Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727 | Treatment (Belinostat, ASTX727) | Neutropenia (Grades 3-4) | 6 | Participants | |
| Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727 | Treatment (Belinostat, ASTX727) | Anemia (Grades 1-2) | 5 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Belinostat, SGI-110) | 6 | |
| Overall Study | STARTED | Treatment (Belinostat, ASTX727) | 13 | |
| Overall Study | COMPLETED | Treatment (Belinostat, SGI-110) | 6 | |
| Overall Study | COMPLETED | Treatment (Belinostat, ASTX727) | 9 | |
| Overall Study | NOT COMPLETED | Treatment (Belinostat, SGI-110) | 0 | |
| Overall Study | NOT COMPLETED | Treatment (Belinostat, ASTX727) | 4 |
Source ClinicalTrials.gov
Adverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Belinostat, SGI-110) | 1 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Belinostat, ASTX727) | 6 | 13 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Treatment (Belinostat, SGI-110) | 0 | 6 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Treatment (Belinostat, ASTX727) | 1 | 13 | |
| other | Electrocardiogram QT corrected interval prolonged | Cardiac disorders | Treatment (Belinostat, SGI-110) | 0 | 6 | |
| other | Electrocardiogram QT corrected interval prolonged | Cardiac disorders | Treatment (Belinostat, ASTX727) | 1 | 13 | |
| other | Ear pain | Ear and labyrinth disorders | Treatment (Belinostat, SGI-110) | 0 | 6 | |
| other | Ear pain | Ear and labyrinth disorders | Treatment (Belinostat, ASTX727) | 1 | 13 | |
| other | Constipation | Gastrointestinal disorders | Treatment (Belinostat, SGI-110) | 1 | 6 | |
| other | Constipation | Gastrointestinal disorders | Treatment (Belinostat, ASTX727) | 3 | 13 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Belinostat, SGI-110) | 3 | 6 |
| Total, all-cause mortality | Treatment (Belinostat, ASTX727) | 6 | 13 |
| Total, other adverse events | Treatment (Belinostat, SGI-110) | 6 | 6 |
| Total, other adverse events | Treatment (Belinostat, ASTX727) | 12 | 13 |
| Total, serious adverse events | Treatment (Belinostat, SGI-110) | 0 | 6 |
| Total, serious adverse events | Treatment (Belinostat, ASTX727) | 6 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34552007 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186686 | NCI Experimental Therapeutics-Clinical Trials Network with Phase 1 Emphasis | ADJEI, ALEX A. | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 2014 to 2019 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment (Belinostat, SGI-110) vs Treatment (Belinostat, ASTX727): deaths from any cause | Trial comparisons |
| Treatment (Belinostat, SGI-110) vs Treatment (Belinostat, ASTX727): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04340843
GET https://conductscience.org/api/trials/v1/NCT04340843/results?page=2