Trial Outcomes & Findings for Tazemetostat in Malignant Peripheral Nerve Sheath Tumors (NCT NCT04917042)
NCT ID: NCT04917042
Last Updated: 2026-02-04
Results Overview
Assess the objective response rate, defined as the proportion of subjects who achieve either a complete response or partial response based on radiographic evaluation of treatment response via RECIST1.1. A complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
143 days
Results posted on
2026-02-04
Participant Flow
Participant milestones
| Measure |
Tazemetostat
Tazemetostat: Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Tazemetostat
Tazemetostat: Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
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|---|---|
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Overall Study
Subject is still on long-term follow-up
|
1
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Baseline Characteristics
Tazemetostat in Malignant Peripheral Nerve Sheath Tumors
Baseline characteristics by cohort
| Measure |
Tazemetostat
n=10 Participants
Tazemetostat: Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
|
Age, Continuous
|
40 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 143 daysPopulation: One participant was not evaluable for this outcome measure because a RECIST response was not obtained after baseline.
Assess the objective response rate, defined as the proportion of subjects who achieve either a complete response or partial response based on radiographic evaluation of treatment response via RECIST1.1. A complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Tazemetostat
n=9 Participants
Tazemetostat: Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
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|---|---|
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Objective Response Rate
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 143 daysPopulation: One participant was not evaluable for this outcome measure because a RECIST response was not obtained after baseline.
Determine the progression free survival, defined as the length of time from the date of start of treatment to the date of disease progression per RECIST 1.1 criteria. Per RECIST 1.1 criteria, disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Outcome measures
| Measure |
Tazemetostat
n=9 Participants
Tazemetostat: Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
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|---|---|
|
Progression Free Survival
|
1.9 months
Interval 1.2 to
The upper limit of the confidence interval is not estimable because fewer than half of the participants had progressed by the end of follow-up.
|
SECONDARY outcome
Timeframe: 143 daysPopulation: One participant was not evaluable for this outcome measure because a RECIST response was not obtained after baseline.
Determine the time to progression, defined as the length of time from the start of treatment until disease progression by RECIST 1.1 criteria. Per RECIST 1.1 criteria, disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Outcome measures
| Measure |
Tazemetostat
n=9 Participants
Tazemetostat: Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
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|---|---|
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Time to Progression
|
1.9 months
Interval 1.2 to
The upper limit of the confidence interval is not estimable because fewer than half of the participants had progressed by the end of follow-up.
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SECONDARY outcome
Timeframe: 143 daysPopulation: One participant was not included as they were not evaluable.
Determine the clinical benefit using the Numbered Pain Rating Scale. For this scale, the subject rates their pain on a scale of 0 to 10. Zero means "no pain," and 10 means "the worst possible pain." For each patient, the mean pain rating scale score was computed by adding all the non-missing scores the patient had and then taking the average.
Outcome measures
| Measure |
Tazemetostat
n=9 Participants
Tazemetostat: Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
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|---|---|
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Clinical Benefit
|
3.4 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 143 daysPopulation: One participant was not evaluable for this outcome measure because a RECIST response was not obtained after baseline.
Assess the clinical benefit rate, defined as the proportion of subjects with complete or partial response or stable disease (by RECIST 1.1 criteria) lasting at least 4 months. Per RECiST 1.1 criteria, a complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Stable disease is defined as having neither sufficient shrinkage for a partial response nor sufficient increase for progressive disease, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Tazemetostat
n=9 Participants
Tazemetostat: Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
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|---|---|
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Clinical Benefit Rate
|
0 percentage of participants
|
Adverse Events
Tazemetostat
Serious events: 4 serious events
Other events: 10 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Tazemetostat
n=10 participants at risk
Tazemetostat: Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
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|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
30.0%
3/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Vascular disorders
Superior vena cava syndrome
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Infections and infestations
Lung infection
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Disease Progression
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Progressive Disease
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
Other adverse events
| Measure |
Tazemetostat
n=10 participants at risk
Tazemetostat: Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
|
|---|---|
|
Gastrointestinal disorders
Anal fissure
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Cholesterol high
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Fatigue
|
60.0%
6/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Flu-like symptoms
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
2/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Psychiatric disorders
Hallucinations
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Vascular disorders
Hot flashes
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
2/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Nervous system disorders
Movements involuntary
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
20.0%
2/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Nausea
|
70.0%
7/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Pain
|
20.0%
2/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
20.0%
2/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
2/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Weight loss
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Infections and infestations
Wound infection
|
10.0%
1/10 • Adverse events were collected from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were collected for up to 169 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the start of study therapy until 28 days after the last dose of study treatment. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place