Trial Outcomes & Findings for Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (NCT NCT04340843)
NCT ID: NCT04340843
Last Updated: 2026-04-13
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Within 6 months after initiating study treatment
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
Treatment (Belinostat, SGI-110)
Patients receive SGI-110 (guadecitabine) SC 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 (Belinostat, ASTX727)
Patients receive ASTX727 (decitabine/cedazuridine) 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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
13
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Belinostat, SGI-110)
Patients receive SGI-110 (guadecitabine) SC 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 (Belinostat, ASTX727)
Patients receive ASTX727 (decitabine/cedazuridine) 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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma
Baseline characteristics by cohort
| Measure |
Treatment (Belinostat, SGI-110)
n=6 Participants
Patients receive SGI-110 (guadecitabine) SC 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 (Belinostat, ASTX727)
n=13 Participants
Patients receive ASTX727 ((decitabine/cedazuridine) 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.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
49.5 years
n=193 Participants
|
67 years
n=193 Participants
|
62 years
n=386 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=193 Participants
|
10 Participants
n=193 Participants
|
14 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
17 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
17 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=193 Participants
|
13 participants
n=193 Participants
|
19 participants
n=386 Participants
|
|
Histology
Grade 1
|
2 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
|
Histology
Grade ≥ 2
|
4 Participants
n=193 Participants
|
9 Participants
n=193 Participants
|
13 Participants
n=386 Participants
|
|
Histology
Unknown
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
IDH mutation status
IDH mutation presence
|
2 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
8 Participants
n=386 Participants
|
|
IDH mutation status
IDH mutation absence
|
4 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
|
IDH mutation status
Unknown
|
0 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Prior lines of treatment
0 prior lines
|
1 Participants
n=193 Participants
|
9 Participants
n=193 Participants
|
10 Participants
n=386 Participants
|
|
Prior lines of treatment
1 prior line
|
1 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Prior lines of treatment
2 prior lines
|
2 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Prior lines of treatment
3+ prior lines
|
2 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Prior therapies (by class)
Pazopanib
|
3 participants
n=193 Participants
|
1 participants
n=193 Participants
|
4 participants
n=386 Participants
|
|
Prior therapies (by class)
Ivosidenib
|
2 participants
n=193 Participants
|
1 participants
n=193 Participants
|
3 participants
n=386 Participants
|
|
Prior therapies (by class)
Anti-PD1 monotherapy
|
2 participants
n=193 Participants
|
1 participants
n=193 Participants
|
3 participants
n=386 Participants
|
|
Prior therapies (by class)
INBRX-109
|
0 participants
n=193 Participants
|
1 participants
n=193 Participants
|
1 participants
n=386 Participants
|
|
Prior therapies (by class)
Everolimus
|
1 participants
n=193 Participants
|
0 participants
n=193 Participants
|
1 participants
n=386 Participants
|
|
Prior therapies (by class)
Olutasidenib
|
1 participants
n=193 Participants
|
1 participants
n=193 Participants
|
2 participants
n=386 Participants
|
|
Prior therapies (by class)
Regorafenib
|
1 participants
n=193 Participants
|
0 participants
n=193 Participants
|
1 participants
n=386 Participants
|
|
Prior therapies (by class)
Cabozantinib, Ipilimumab, Nivolumab
|
1 participants
n=193 Participants
|
0 participants
n=193 Participants
|
1 participants
n=386 Participants
|
|
Prior therapies (by class)
Other
|
1 participants
n=193 Participants
|
0 participants
n=193 Participants
|
1 participants
n=386 Participants
|
|
Prior surgery
|
5 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
17 Participants
n=386 Participants
|
|
Prior radiation
|
1 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: Within 6 months after initiating study treatmentBest 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.
Outcome measures
| Measure |
Treatment (Belinostat, ASTX727)
n=13 Participants
Patients receive ASTX727 ((decitabine/cedazuridine) 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.
|
|---|---|
|
Objective Response Rate (ORR) in Belinostat, ASTX727
PD
|
4 Participants
|
|
Objective Response Rate (ORR) in Belinostat, ASTX727
Not Evaluable
|
3 Participants
|
|
Objective Response Rate (ORR) in Belinostat, ASTX727
CR/PR
|
0 Participants
|
|
Objective Response Rate (ORR) in Belinostat, ASTX727
SD
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months post treatmentPopulation: Treatment-Related Adverse Events Occurring in \> 20% of patients treated with belinostat, ASTX727
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.
Outcome measures
| Measure |
Treatment (Belinostat, ASTX727)
n=13 Participants
Patients receive ASTX727 ((decitabine/cedazuridine) 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.
|
|---|---|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Anemia (Grades 3-4)
|
1 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Fatigue (Grades 1-2)
|
5 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Vomiting (Grades 1-2)
|
4 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Constipation (Grades 1-2)
|
3 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Lymphopenia (Grades 1-2)
|
1 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Nausea (Grades 1-2)
|
9 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Leukopenia (Grades 1-2)
|
5 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Leukopenia (Grades 3-4)
|
3 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Neutropenia (Grades 1-2)
|
1 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Neutropenia (Grades 3-4)
|
6 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Anemia (Grades 1-2)
|
5 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Fatigue (Grades 3-4)
|
1 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Thrombocytopenia (Grades 1-2)
|
4 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Thrombocytopenia (Grades 3-4)
|
1 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Infusion Reaction (Grades 1-2)
|
4 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, ASTX727
Lymphopenia (Grades 3-4)
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment (Belinostat, ASTX727)
n=13 Participants
Patients receive ASTX727 ((decitabine/cedazuridine) 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.
|
|---|---|
|
Progression Free Survival (PFS) in Belinostat, ASTX727
|
3.72 months
Interval 1.83 to
The upper bound Confidence Interval cannot be assessed as there are too few progression events.
|
SECONDARY outcome
Timeframe: Up to 24 months post treatmentPopulation: Treatment-Related Adverse Events Occurring in \> 20% of patients treated with belinostat, SGI-110
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.
Outcome measures
| Measure |
Treatment (Belinostat, ASTX727)
n=6 Participants
Patients receive ASTX727 ((decitabine/cedazuridine) 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.
|
|---|---|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110
Injection reaction (Grades 1-2)
|
3 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110
Vomiting (Grades 1-2)
|
3 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110
Neutropenia (Grades 1-2)
|
1 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110
Neutropenia (Grades 3-4)
|
1 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110
Pain (Grades 1-2)
|
2 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110
Fatigue (Grades 1-2)
|
3 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110
Infusion reaction (Grades 1-2)
|
3 Participants
|
|
Presence of Treatment Related Adverse Events (AEs) in Belinostat, SGI-110
Nausea (Grades 1-2)
|
4 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment (Belinostat, ASTX727)
n=6 Participants
Patients receive ASTX727 ((decitabine/cedazuridine) 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.
|
|---|---|
|
Progression Free Survival (PFS) in Belinostat, SGI-110
|
3.73 months
Interval 1.87 to
The upper bound Confidence Interval cannot be assessed as there are too few progression events.
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment (Belinostat, ASTX727)
n=6 Participants
Patients receive ASTX727 ((decitabine/cedazuridine) 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.
|
|---|---|
|
Objective Response Rate (ORR) in Belinostat, SGI-110
CR/PR
|
0 Participants
|
|
Objective Response Rate (ORR) in Belinostat, SGI-110
SD
|
6 Participants
|
|
Objective Response Rate (ORR) in Belinostat, SGI-110
PD
|
0 Participants
|
|
Objective Response Rate (ORR) in Belinostat, SGI-110
Not evaluable
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 months post treatmentWill 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 24 months post treatmentData 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 24 months post treatmentA Wilcoxon signed-rank test with continuity correction will be used to calculate P values for comparing methylation level distribution at the different time points.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 24 months post treatmentFor 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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Belinostat, SGI-110)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 3 deaths
Treatment (Belinostat, ASTX727)
Serious events: 6 serious events
Other events: 12 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Treatment (Belinostat, SGI-110)
n=6 participants at risk
Patients receive SGI-110 (guadecitabine) SC 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 (Belinostat, ASTX727)
n=13 participants at risk
Patients receive ASTX727 (decitabine/cedazuridine) 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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
15.4%
2/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Nervous system disorders
Concentration Impairment
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
Other adverse events
| Measure |
Treatment (Belinostat, SGI-110)
n=6 participants at risk
Patients receive SGI-110 (guadecitabine) SC 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 (Belinostat, ASTX727)
n=13 participants at risk
Patients receive ASTX727 (decitabine/cedazuridine) 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.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Infections and infestations
Thrush
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
46.2%
6/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
23.1%
3/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
15.4%
2/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
69.2%
9/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
30.8%
4/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
General disorders
Chills
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
46.2%
6/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
General disorders
Fever
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
0.00%
0/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
General disorders
Infusion related reaction
|
50.0%
3/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
30.8%
4/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
General disorders
Injection site reaction
|
50.0%
3/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
General disorders
Pain
|
33.3%
2/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
0.00%
0/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Infections and infestations
Phlebitis infective
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
0.00%
0/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
61.5%
8/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
15.4%
2/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
15.4%
2/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
0.00%
0/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Nervous system disorders
Concentration impairment
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
0.00%
0/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
0.00%
0/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
23.1%
3/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
53.8%
7/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
38.5%
5/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Investigations
Weight loss
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mucositis
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Skin and subcutaneous tissue disorders
Non-pruritic rash
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
0.00%
0/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Skin and subcutaneous tissue disorders
Skin pain
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
0.00%
0/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
7.7%
1/13 • Up to 24 months post treatment
Adverse events were recorded at each clinical visit and were categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be reported as counts and percentages per AE by grade and the number of patients with a given maximal grade of toxicity.
|
Additional Information
Dr. Mia Weiss
Washington University in St. Louis School of Medicine
Phone: 3147473096
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60