Trial Outcomes & Findings for Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL) (NCT NCT03547700)
NCT ID: NCT03547700
Last Updated: 2026-05-06
Results Overview
MTD is the dose level with a model-estimated rate of Dose Limiting Toxicities (DLT) closest to 25% after 36 patients have been enrolled. The maximum tolerated dose could not be determined because the trial was terminated early, however the number of participants who experienced DLTs found at each dose level is reported in a new outcome measure.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
From first dose of treatment through the 1st cycle (28 days)
Results posted on
2026-05-06
Participant Flow
This study was terminated prior to opening the Phase II portion of the trial.
Participant milestones
| Measure |
Phase I Dose Level 4:Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 10mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
9
|
1
|
|
Overall Study
DLT Period (First 28 Days of Treatment)
|
1
|
9
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
9
|
1
|
Reasons for withdrawal
| Measure |
Phase I Dose Level 4:Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 10mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
3
|
0
|
|
Overall Study
Study Terminated
|
0
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Refused to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)
Baseline characteristics by cohort
| Measure |
Phase I Dose Level 4:Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
n=1 Participants
Romidepsin 10mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
n=9 Participants
Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
n=1 Participants
Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
n=54 Participants
|
62 years
n=60 Participants
|
55 years
n=114 Participants
|
62 years
n=480 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
3 Participants
n=480 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
8 Participants
n=480 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
2 Participants
n=480 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=54 Participants
|
7 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
9 Participants
n=480 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
2 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
3 Participants
n=480 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
5 Participants
n=480 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=480 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=54 Participants
|
9 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
11 Participants
n=480 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Score
ECOG Peformance Score 0
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
2 Participants
n=480 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Score
ECOG Peformance Score 1
|
0 Participants
n=54 Participants
|
8 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
8 Participants
n=480 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Score
ECOG Peformance Score 2
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=480 Participants
|
PRIMARY outcome
Timeframe: From first dose of treatment through the 1st cycle (28 days)MTD is the dose level with a model-estimated rate of Dose Limiting Toxicities (DLT) closest to 25% after 36 patients have been enrolled. The maximum tolerated dose could not be determined because the trial was terminated early, however the number of participants who experienced DLTs found at each dose level is reported in a new outcome measure.
Outcome measures
| Measure |
All Subjects Treated
n=11 Participants
Romidepsin dose of either 10mg/m², 14mg/m² IV on days 1, 8, 15, or 14mg/m² on days 1 and 8 : Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
|---|---|---|---|
|
Phase I: Maximum Tolerated Dose (MTD)
|
NA mg/m^2
Since the minimum number of subjects needed to evaluate MTD were not enrolled, the MTD could not be determined.
|
—
|
—
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Data for this primary objective was not collected or analyzed due to the early termination of the study by the funder prior to any phase II activity.
The complete response (CR) rate of this combination in relapsed/refractory PTCL is defined as complete metabolic response recorded from first day of treatment until disease progression or initiation of new antineoplastic therapy, as per the Lugano response criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: Data for this secondary outcome was not collected or analyzed due to the early termination of the study by the funder prior to the start of any Phase II activity.
OR, defined as complete or partial metabolic response recorded from first day of treatment until disease progression/recurrence or initiation of new antineoplastic therapy, as per the Lugano response criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: Data for this secondary outcome was not collected or analyzed due to the early termination of the study by the funder prior to any phase II activity.
DOR, defined as time that measurement criteria are met for complete or partial metabolic response (whichever status is recorded first) until disease progression/recurrence or initiation of new antineoplastic therapy, as per the Lugano response criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: Data for this secondary outcome was not collected or analyzed due to the early termination of the study by the funder prior to any phase II activity.
TTNT defined as the date of initiation of treatment until death or the date of initiation of the next treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: Data for this secondary outcome was not collected or analyzed due to the early termination of the study by the funder prior to any phase II activity.
OS, defined as time from first day of treatment to time of death.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: From first dose of treatment through the 1st cycle (28 days)A DLT is defined as any of the following adverse events (AEs) that are possibly, probably, or definitely related to the combination of ixazomib and romidepsin that occurs during the 1st cycle. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4 will be used. * Grade 4 Neutropenia \>=14 days * Febrile neutropenia: Grade 3 or 4 neutropenia with fever ˃ 38ºC, both sustained over a 24-hour period * Anemia Grade 3/4 * Thrombocytopenia: Grade ≥ 4 lasting greater than 7 days or Grade ≥ 3 complicated by at least a Grade 2 hemorrhage * Grade 3/4 Non-Hematologic Toxicities. (excluding alopecia, fatigue or anorexia lasting ˂ 7 days, or Grade 3 nausea and/or vomiting that persists for ˂ 2 days following appropriate supportive care). Nausea, vomiting, or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy * Grade 3/4 Infection * Any Grade 5 events * Grade ≥ 3 electrolyte abnormalities that do not resolve to ≤Grade 2 or baselinewithin 7 days
Outcome measures
| Measure |
All Subjects Treated
n=1 Participants
Romidepsin dose of either 10mg/m², 14mg/m² IV on days 1, 8, 15, or 14mg/m² on days 1 and 8 : Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
n=9 Participants
Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
n=1 Participants
Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
|---|---|---|---|
|
Count of Participants Experiencing Dose Limiting Toxicities (DLTs) at Each Dose Level.
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Phase I Dose Level 4: Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
Serious events: 3 serious events
Other events: 9 other events
Deaths: 3 deaths
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Dose Level 4: Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
n=1 participants at risk
Romidepsin 10mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
n=9 participants at risk
Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
n=1 participants at risk
Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
|---|---|---|---|
|
General disorders
FATIGUE
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 2 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
General disorders
FEVER
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Cardiac disorders
CARDIAC DISORDERS - OTHER, SPECIFY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/9 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
Other adverse events
| Measure |
Phase I Dose Level 4: Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
n=1 participants at risk
Romidepsin 10mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
n=9 participants at risk
Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
n=1 participants at risk
Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
|
|---|---|---|---|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/9 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Investigations
CREATININE INCREASED
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Gastrointestinal disorders
DIARRHEA
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
55.6%
5/9 • Number of events 6 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Nervous system disorders
DIZZINESS
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/9 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Gastrointestinal disorders
NAUSEA
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
66.7%
6/9 • Number of events 11 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Gastrointestinal disorders
VOMITING
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
66.7%
6/9 • Number of events 9 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
55.6%
5/9 • Number of events 6 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
33.3%
3/9 • Number of events 3 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
General disorders
CHILLS
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
22.2%
2/9 • Number of events 2 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 2 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
General disorders
EDEMA LIMBS
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
33.3%
3/9 • Number of events 5 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
General disorders
EDEMA TRUNK
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Eye disorders
EYE DISORDERS - OTHER, SPECIFY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
General disorders
FATIGUE
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
77.8%
7/9 • Number of events 10 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
General disorders
FEVER
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
33.3%
3/9 • Number of events 4 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
22.2%
2/9 • Number of events 2 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 2 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
22.2%
2/9 • Number of events 3 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 2 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Investigations
INVESTIGATIONS - OTHER, SPECIFY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
General disorders
LOCALIZED EDEMA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
33.3%
3/9 • Number of events 9 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Metabolism and nutrition disorders
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Infections and infestations
MUCOSAL INFECTION
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
44.4%
4/9 • Number of events 8 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
22.2%
2/9 • Number of events 2 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
55.6%
5/9 • Number of events 16 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Infections and infestations
RASH PUSTULAR
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Nervous system disorders
SINUS PAIN
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/9 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
100.0%
1/1 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 2 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
22.2%
2/9 • Number of events 2 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOR PAIN
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
22.2%
2/9 • Number of events 3 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Investigations
WEIGHT GAIN
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Investigations
WEIGHT LOSS
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
11.1%
1/9 • Number of events 1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
33.3%
3/9 • Number of events 7 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
0.00%
0/1 • AEs were recorded from time of signed informed consent until 30 days after discontinuation of study drug(s), an average of 4 months per participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place