Hematologic Malignancy, Malignant Lymphoma
Conditions
Keywords
ROMI-001, romi, Romidepsin, Istodax, advanced malignancy, PK, pharmacokinetics
Brief summary
The purpose of this study is to evaluate the effect and safety of multiple doses of rifampin on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.
Interventions
DRUGRomidepsin
14 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8.
DRUGRifampin
600 mg oral once daily on Days 4-8
Sponsors
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females 18 years of age or older at the time of signing the informed consent document. 2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Must have diagnosis of advanced malignancy and must have failed other available therapies considered standard of care for their disease. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 6. Negative urine or serum pregnancy test on females of childbearing potential; and 7. All females of childbearing potential must use an effective barrier method of contraception (either an intrauterine contraceptive device \[IUCD\] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male subjects should use a barrier method of contraception during the treatment period and for at least 3 months thereafter. Female subjects should avoid the use of estrogen-containing contraceptives, since romidepsin may reduce the effectiveness of estrogen-containing contraceptives. An in vitro binding assay determined that romidepsin competes with β-estradiol for binding to estrogen receptors.
Exclusion criteria
1. Any significant medical condition or psychiatric illness that would prevent the subject from participating in the study. 2. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 3. Subjects with significant gastrointestinal disease that may impair drug absorption, such as subjects with a history of Cohn's disease, colectomy, gastrectomy, celiac disease, or other diseases with known malabsorption. 4. Serum potassium \< 3.8 mmol/L or serum magnesium \< 0.85 mmol/L (magnesium converts to 2.1 mg/dl or 1.7 mEq/L) (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria). 5. Concomitant use of drugs that may cause a significant prolongation of the corrected measurement of the time between the start of the cardiac Q wave and the end of the T wave (QTc). 6. Concomitant use of Cytochrome P 450 3A4 (CYP3A4) strong inhibitors within 1 week of trial medications. 7. Concomitant use of CYP3A4 strong inducers within 2 weeks of trial medications. 8. Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted. 9. Clinically significant active infection. 10. Known infection with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C. 11. Inadequate bone marrow or other organ function as evidenced by: * Hemoglobin \< 9 g/dL (transfusions and/or erythropoietin are permitted); * Absolute neutrophil count (ANC) ≤ 1.0 \* 10\^9 cells/L \[subjects with neutropenia (ANC 1-1.5) as a function of their disease may be supported with granulocyte-colony stimulating factor (G-CSF)\]; * Platelet count \< 100 \* 10\^9 cells/L or platelet count \< 75 \* 10\^9 cells/L if bone marrow disease involvement is documented; * Total bilirubin \> 1.5 \* upper limit of normal (ULN) or \> 2.0 \* ULN in the presence of demonstrable liver metastases; * Serum aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) \> 1.5 \* ULN or \> 2.0 \* ULN in the presence of demonstrable liver metastases; or * Serum creatinine \> 2.0 \* ULN; 12. Prior chemotherapy treatment within 3 weeks prior to the first day of romidepsin treatment (6 weeks for nitrosoureas) or prior treatment with an investigational agent within 4 weeks prior to the first day of romidepsin treatment. 13. Prior radiotherapy within 4 weeks prior to the first day of treatment. Subjects who have not fully recovered or whose acute toxicity related to prior radiotherapy has not returned to baseline are ineligible. 14. Major surgery within 2 weeks of study entry (day 1). 15. Concomitant use of any other anti-cancer therapy. 16. Concomitant use of any investigational agent. 17. Prior exposure to romidepsin (other histone deacetylase \[HDAC\] inhibitors are allowed). 18. Any known cardiac abnormalities, such as: * Congenital long measure of the time between the start of the Q wave and the end of the T wave (QT) syndrome; * Mean QTc formula (QTcF) interval \> 450 msec; * A myocardial infarction within 12 months of study entry; * A history of coronary artery disease (CAD), e.g., angina Canadian Class II-IV. A stress imaging study should be performed for any subject whose cardiac status is uncertain. If abnormal, an angiography should be completed to define whether or not CAD is present. * An electrocardiogram (ECG) recorded at screening showing evidence of cardiac ischemia (ST depression of ≥ 2 mm, measured from isoelectric line to ST segment). A stress imaging study should be performed for any subject whose cardiac status is uncertain. If abnormal, an angiography should be completed to define whether or not CAD is present. * Congestive Heart Failure (CHF) that meets the New York Heart Association (NYHA) Class II to IV definitions (see Appendix F) and/or ejection fraction \< 40% by multi gated acquisition (MUGA) scan or \< 50% by echocardiogram and/or magnetic resonance imaging (MRI); * A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), torsades de pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD); * Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above); * Uncontrolled hypertension, i.e., blood pressure (BP) of ≥ 160/95; or * Any cardiac arrhythmia requiring anti-arrhythmic medication. 19. Subjects who are pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Total Volume of Distribution (Vz). | Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion. | Apparent total volume of distribution (Vz) was calculated as \[(CL)/λz\] for Romidepsin and co-administered with Rifampin. |
| Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin | Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion. | AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. |
| Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC0-24) for Romidepsin | Day 1 and Day 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion. | Individual and mean romidepsin plasma concentrations by treatment and scheduled time data were collected. AUC0-24: area under the plasma concentration time-curve from Time 0 to 24 hours, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. |
| Area Under the Plasma Concentration Time-curve From Time Zero Extrapolated to Infinity (AUC0-∞). | Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion. | AUC0-∞: area under the plasma concentration time-curve from Time 0 extrapolated to infinity, calculated as \[AUCt + Ct/λz\]. λz is the apparent terminal rate constant. No AUC extrapolation was performed with unreliable λz. If the percentage of AUC extrapolated is ≥ 25%, AUC0-∞ will not be reported. |
| Maximum Observed Plasma Concentration (Cmax)of Romidepsin | Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion. | Maximum observed plasma concentration (Cmax)was obtained directly from the observed concentration versus time data. |
| Time to Maximum Observed Plasma Concentration (Tmax) | Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion. | Time to maximum observed plasma concentration (Tmax) was obtained directly from the observed concentration versus time data. |
| Estimate of the Terminal Elimination Half-life in Plasma (t1/2) | Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion. | The terminal elimination half-life (t1/2) in plasma, was calculated as \[(ln 2)/λz\]. This was only calculated when a reliable estimate for λz could be obtained. |
| Clearance (CL): Apparent Total Plasma Clearance. | Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion. | The apparent total plasma clearance (CL) was calculated as \[Dose/AUC0-∞\] for Romidepsin alone and co-administered with rifampin plasma concentrations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | Day 1 up to Day 36 (28 days after the last treatment) | AEs were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. |
Countries
United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 3 study centers (2 in the United States and 1 in the United Kingdom). The first subject was enrolled in April 2011 and the last subject completed the study in Feb 2012.
Participants by arm
| Arm | Count |
|---|---|
| Romidepsin and Rifampin Romidepsin 14 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8.
Rifampin 600 mg oral once daily on Days 4-8 | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Romidepsin and Rifampin |
|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 12.57 |
| Body Surface Area (BSA) | 1.9 Metered Squares m^2 STANDARD_DEVIATION 0.22 |
| Eastern Cooperative Oncology Group Performance Status (ECOG) 0 = Fully active | 7 Participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG) 1 = Restricted in physical strenuous activity | 7 Participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG) 2 = Ambulaotry but unable to work | 0 Participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG) 3 = Limited Self-Care | 0 Participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG) 4 = Completely Disabled | 0 Participants |
| Height | 167.6 Centimeters STANDARD_DEVIATION 9.54 |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 14 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized White | 13 Participants |
| Region of Enrollment United Kingdom | 5 participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
| Weight | 78.2 kilograms STANDARD_DEVIATION 18.85 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 14 |
| serious Total, serious adverse events | 2 / 14 |
Outcome results
Primary
Apparent Total Volume of Distribution (Vz).
Apparent total volume of distribution (Vz) was calculated as \[(CL)/λz\] for Romidepsin and co-administered with Rifampin.
Time frame: Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.
Population: The PK population was to consist of all participants who received at least 1 dose of study drug and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Romidepsin Day 1 | Apparent Total Volume of Distribution (Vz). | 161.48 Liters | Geometric Coefficient of Variation 78.6 |
| Romidepsin and Rifampin Day 8 | Apparent Total Volume of Distribution (Vz). | 77.6 Liters | Geometric Coefficient of Variation 93.8 |
Primary
Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC0-24) for Romidepsin
Individual and mean romidepsin plasma concentrations by treatment and scheduled time data were collected. AUC0-24: area under the plasma concentration time-curve from Time 0 to 24 hours, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.
Time frame: Day 1 and Day 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.
Population: The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Romidepsin Day 1 | Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC0-24) for Romidepsin | 2204.2 ng*hr/mL | Geometric Coefficient of Variation 72 |
| Romidepsin and Rifampin Day 8 | Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC0-24) for Romidepsin | 3903.9 ng*hr/mL | Geometric Coefficient of Variation 78 |
90% CI: [159.4, 199.4]ANOVA
Primary
Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin
AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.
Time frame: Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.
Population: The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Romidepsin Day 1 | Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin | 2225.1 ng*hr/mL | Geometric Coefficient of Variation 71.4 |
| Romidepsin and Rifampin Day 8 | Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin | 3966.3 ng*hr/mL | Geometric Coefficient of Variation 76.5 |
90% CI: [160.3, 200.7]ANOVA
Primary
Area Under the Plasma Concentration Time-curve From Time Zero Extrapolated to Infinity (AUC0-∞).
AUC0-∞: area under the plasma concentration time-curve from Time 0 extrapolated to infinity, calculated as \[AUCt + Ct/λz\]. λz is the apparent terminal rate constant. No AUC extrapolation was performed with unreliable λz. If the percentage of AUC extrapolated is ≥ 25%, AUC0-∞ will not be reported.
Time frame: Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.
Population: The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Romidepsin Day 1 | Area Under the Plasma Concentration Time-curve From Time Zero Extrapolated to Infinity (AUC0-∞). | 2229.8 ng*hr/mL | Geometric Coefficient of Variation 71.3 |
| Romidepsin and Rifampin Day 8 | Area Under the Plasma Concentration Time-curve From Time Zero Extrapolated to Infinity (AUC0-∞). | 3980.7 ng*hr/mL | Geometric Coefficient of Variation 76.1 |
90% CI: [160.5, 201]ANOVA
Primary
Clearance (CL): Apparent Total Plasma Clearance.
The apparent total plasma clearance (CL) was calculated as \[Dose/AUC0-∞\] for Romidepsin alone and co-administered with rifampin plasma concentrations.
Time frame: Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.
Population: The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Romidepsin Day 1 | Clearance (CL): Apparent Total Plasma Clearance. | 11.59 L/hr | Geometric Coefficient of Variation 78.1 |
| Romidepsin and Rifampin Day 8 | Clearance (CL): Apparent Total Plasma Clearance. | 6.45 L/hr | Geometric Coefficient of Variation 82.2 |
Primary
Estimate of the Terminal Elimination Half-life in Plasma (t1/2)
The terminal elimination half-life (t1/2) in plasma, was calculated as \[(ln 2)/λz\]. This was only calculated when a reliable estimate for λz could be obtained.
Time frame: Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.
Population: The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Romidepsin Day 1 | Estimate of the Terminal Elimination Half-life in Plasma (t1/2) | 9.666 hours | Geometric Coefficient of Variation 27.9 |
| Romidepsin and Rifampin Day 8 | Estimate of the Terminal Elimination Half-life in Plasma (t1/2) | 8.341 hours | Geometric Coefficient of Variation 24 |
Primary
Maximum Observed Plasma Concentration (Cmax)of Romidepsin
Maximum observed plasma concentration (Cmax)was obtained directly from the observed concentration versus time data.
Time frame: Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.
Population: The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Romidepsin Day 1 | Maximum Observed Plasma Concentration (Cmax)of Romidepsin | 571.2 ng/mL | Geometric Coefficient of Variation 81 |
| Romidepsin and Rifampin Day 8 | Maximum Observed Plasma Concentration (Cmax)of Romidepsin | 900.1 ng/mL | Geometric Coefficient of Variation 104.9 |
90% CI: [135.8, 186.5]ANOVA
Primary
Time to Maximum Observed Plasma Concentration (Tmax)
Time to maximum observed plasma concentration (Tmax) was obtained directly from the observed concentration versus time data.
Time frame: Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.
Population: The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Romidepsin Day 1 | Time to Maximum Observed Plasma Concentration (Tmax) | 3.0 hours | Full Range 51.5 |
| Romidepsin and Rifampin Day 8 | Time to Maximum Observed Plasma Concentration (Tmax) | 3.00 hours | Full Range 50.7 |
Comparison: Note: The median, median difference (romidepsin + rifampin minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test.p-value: 0.79190% CI: [-1, 1.01]Wilcoxon signed-rank
Secondary
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
AEs were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Day 1 up to Day 36 (28 days after the last treatment)
Population: The safety population included all subjects who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 Serious TEAE | 2 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 TEAE | 13 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 TEAE related to any study drug | 13 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 TEAE related to Romidepsin | 13 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 TEAE related to Rifampin | 2 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 Serious TEAE related to any drug | 1 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 Serious TEAE related to Romidepsin | 1 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 Serious TEAE related to Rifampin | 1 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 TEAE leading to discontinuation | 0 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 TEAE related discontinuation to any drug | 0 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 Romidepsin related TEAE discontinuation | 0 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | = > 1 Rifampin related TEAE discontinuation | 0 participants |
| Romidepsin Day 1 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants who died | 0 participants |