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NCT04537715 · REGISTRY CONDITION SEARCH

Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2025-02-19

The participants of this study will have advanced malignancies (also known as advanced cancer). The main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the tazemtostat (the study drug) when administered in combination with another drug. Part 1 of the study will evaluate the interaction between the drugs tazemetostat and itraconazole. Part 2 of the study will evaluate the interaction between the drugs tazemetostat and rifampin For both Parts 1 and 2, safety and the level that effects of the study drug can be tolerated (known as tolerability) will be assessed throughout.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours of Quantifiable Concentration (AUC0-12h) of Tazemetostat

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outcome · POSTED

Part 1: Maximum Observed Plasma Concentration (Cmax) of Tazemetostat

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outcome · POSTED

Part 2: AUC0-12h of Tazemetostat

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outcome · POSTED

Part 2: Cmax of Tazemetostat

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outcome · POSTED

Part 1: AUC0-12h of EPZ-6930 After Tazemetostat Alone at Steady-State

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outcome · POSTED

Part 1: AUC0-12h of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Itraconazole

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outcome · POSTED

Part 1: Cmax of EPZ-6930 After Tazemetostat Alone at Steady-State

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outcome · POSTED

Part 1: Cmax of Tazemetostat and EPZ-6930 After Tazemetostat at Steady State With Itraconazole

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outcome · POSTED

Part 1: Observed Time at Cmax (Tmax) of Tazemetostat and EPZ-6930 After Tazemetostat Alone at Steady-State

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outcome · POSTED

Part 1: Tmax of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Itraconazole

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outcome · POSTED

Part 1: Apparent Terminal Elimination Half-Life (t1/2) of Tazemetostat and EPZ-6930 After Tazemetostat Alone at Steady-State

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outcome · POSTED

Part 1: T1/2 of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Itraconazole

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outcome · POSTED

Part 2: AUC0-12h of EPZ-6930 After Tazemetostat Alone at Steady-State

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outcome · POSTED

Part 2: AUC0-12h of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Rifampin

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outcome · POSTED

Part 2: Cmax of EPZ-6930 After Tazemetostat Alone at Steady-State

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outcome · POSTED

Part 2: Cmax of Tazemetostat and EPZ-6930 After Tazemetostat at Steady State With Rifampin

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outcome · POSTED

Part 2: Tmax of Tazemetostat and EPZ-6930 After Tazemetostat Alone at Steady-State

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outcome · POSTED

Part 2: Tmax of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Rifampin

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outcome · POSTED

Part 2: T1/2 of Tazemetostat and EPZ-6930 EPZ-6930 After Tazemetostat Alone at Steady-State

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outcome · POSTED

Part 2: T1/2 of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Rifampin

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outcome · POSTED

Part 1: Least Squares Geometric Mean Ratio of Observed Accumulation Ratio of AUC0-12h for Tazemetostat

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outcome · POSTED

Part 1: Least Squares Geometric Mean Ratio of Cmax Accumulation Ratio for Tazemetostat

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outcome · POSTED

Part 1: Least Squares Geometric Mean Ratio of AUC0-12h After Single Dose of Tazemetostat With Itraconazole

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outcome · POSTED

Part 1: Least Squares Geometric Mean Ratio of Cmax After Single Dose of Tazemetostat With Itraconazole

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outcome · POSTED

Part 1: Least Squares Geometric Mean Ratio of AUC0-12h After Tazemetostat at Steady-State With Itraconazole

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outcome · POSTED

Part 1: Least Squares Geometric Mean Ratio of Cmax After Tazemetostat at Steady-State With Itraconazole

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outcome · POSTED

Part 2: Least Squares Geometric Mean Ratio of Observed Accumulation Ratio of AUC0-12h for Tazemetostat

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outcome · POSTED

Part 2: Least Squares Geometric Mean Ratio of Cmax Accumulation Ratio for Tazemetostat

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outcome · POSTED

Part 2: Least Squares Geometric Mean Ratio of AUC0-12h After Tazemetostat at Steady State With Rifampin

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outcome · POSTED

Part 2: Least Squares Geometric Mean Ratio of Cmax After Tazemetostat at Steady State With Rifampin

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
INCLUSION CRITERIA: 1. Male or female ≥ 18 years age at the time of consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 3. Has the ability to understand informed consent, and provide signed written informed consent. 4. Life expectancy of \> 3 months. 5. Histologically and/or cytologically confirmed advanced metastatic or unresectable solid tumors has progressed after treatment for which there are no standard therapies available OR histologically and/or cytologically confirmed hematologic malignancies that have relapsed, or refractory disease, following at least 2 standard lines of systemic therapy for which there are no standard therapies available. Note: Subjects with prior radiotherapy will be included; however, radiotherapy alone will not be considered a separate systemic treatment regimen. 6. Must have evaluable or measurable disease. 7. Has all prior treatment (ie, chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ≤ Grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 or are clinically stable and not clinically significant, at time of consent. 8. All subjects must have completed any prior chemotherapy, targeted therapy and major surgery ≥ 28 days before study entry. For daily or weekly chemotherapy without the potential for delayed toxicity, a washout period of 14 days or 5 half-lives, whichever is shorter may be acceptable. 9. Has normal hepatic function (per NCI-ODWG criteria) as well as adequate hematologic (bone marrow \[BM\] and coagulation factors) and renal function. 10. Able to swallow and retain orally-administered medication and without clinically significant gastrointestinal abnormalities that could alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. 11. Females of childbearing potential (FCBP) must have a negative serum pregnancy test and must either practice complete abstinence or agree to use a highly effective method of contraception. 12. Male subjects must have had a successful vasectomy OR must either practice complete abstinence or agree to use a latex or synthetic condom during sexual contact with a female of childbearing potential (FCBP) during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation. NOTE: Male subjects must not donate sperm during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation. 13. Has a QT interval corrected by Fridericia's formula (QTcF) ≤450 msec. EXCLUSION CRITERIA: 1. Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression or primary glioblastoma multiforme. 2. Clinically significant bleeding diathesis or coagulopathy. 3. Known hypersensitivity to any of the components of Tazemetostat, itraconazole, or rifampin. 4. Use of concurrent investigational agent or anticancer therapy. 5. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Have a known active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), AND/OR human T-cell lymphotropic virus 1. 7. Subjects taking medications that are known CYP3A4 inducers or inhibitors (including St. John's Wort). 8. Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit from the diet and all foods that contain those fruits from 24 hours prior to the first dose of study drug until the last dose of study drug. 9. Any condition or medical problem in addition to the underlying malignancy and organ dysfunction that the Investigator feels would pose unacceptable risk. 10. Has a prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN) or T-cell lymphoblastic lymphoma (T-LBL)/ T-cell acute lymphoblastic leukemia (T-ALL). 11. Ingestion of alcohol within 72 hours prior to day 1 of Cycle 1 until the end of Cycle 1 (Day 39 for Part 1 and Day 26 for Part 2). Regular alcohol consumption must not exceed 16 units for males and 7 units for females per week (2 units equals 40mL \[a can\] of beer, 175mL \[a standard glass\] of wine, or 50 mL \[2 small shots\] of spirits 12. Any form of marijuana use. 13. History of drug abuse (including alcohol) within the last 6 months prior to screening.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants in Part 1 of the study will receive a single oral, 400 mg dose of tazemetostat on Day 1, 15, and Day 36. The study participants will receive tazemetostat (oral 400 mg) tablets to be taken twice daily on Days 3 - 14 and Days 21 - 35. In addition, the participants will receive oral 200 mg itraconazole once daily on Days 18 - 38. Study participants may continue tazemetostat from Day 40+ at the recommended therapeutic dose (oral 800 mg twice daily) in 28-day cycles.
    intervention Names
    1. Drug: Tazemetostat
    2. Drug: Itraconazole
    label
    Part 1: Tazemetostat and Itraconazole Drug Interaction Cycle 1
    type
    EXPERIMENTAL
  2. description
    Participants in Part 2 of the study will receive a single oral, 800 mg dose of tazemetostat on Days 1, 15, and Day 36. The study participants will receive tazemetostat (oral 800 mg dose) tablets to be taken twice daily on Days 3 - 14 and Days 17 - 23. In addition, the participants will receive oral 200 mg rifampin once daily on Days 17 - 25. Study participants may continue tazemetostat from Day 27+ at the recommended therapeutic dose (oral 800 mg twice daily) in 28-day cycles.
    intervention Names
    1. Drug: Tazemetostat
    2. Drug: Rifampin
    label
    Part 2:Tazemetostat and Rifampin Drug Interaction Cycle 1
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part 1: Tazemetostat and Itraconazole Drug Interaction Cycle 1
    description
    A single, oral, 400 mg dose of tazemetostat on Day 1, Day 15, and Day 36; and tazemetostat (oral 400 mg) tablets twice daily on Days 3 - 14 and Days 21 - 35.
    name
    Tazemetostat
    other Names
    1. EPZ-6438
    2. Tazverik
    type
    DRUG
  2. arm Group Labels
    1. Part 1: Tazemetostat and Itraconazole Drug Interaction Cycle 1
    description
    Oral 200 mg itraconazole once daily on Days 18 - 38
    name
    Itraconazole
    other Names
    1. Sporanox
    type
    DRUG
  3. arm Group Labels
    1. Part 2:Tazemetostat and Rifampin Drug Interaction Cycle 1
    description
    A single, oral, 800 mg dose of tazemetostat on Days 1, 15, and Day 24 ; and tazemetostat (oral 800 mg) twice daily on Days 3 - 14 and on Days 17 - 23.
    name
    Tazemetostat
    other Names
    1. EPZ-6438
    2. Tazverik
    type
    DRUG
  4. arm Group Labels
    1. Part 2:Tazemetostat and Rifampin Drug Interaction Cycle 1
    description
    Oral 600 mg rifampin once daily on Days 17 - 25.
    name
    Rifampin
    other Names
    1. RIF
    2. Rifampicin
    3. Rifadin
    4. Rimactane
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
CROSSOVER
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
42
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Blood samples were collected at specified timepoints. AUC0-12h accumulation ratio was assessed using non-compartmental data analysis method. AUC0-12h accumulation ratio was calculated as the ratio of AUC0-12h at steady state (Cycle 1 Day 15) divided by AUC0-12 during the initial dosing interval (Cycle 1 Day 1).
    measure
    Part 1: Least Squares Geometric Mean Ratio of Observed Accumulation Ratio of AUC0-12h for Tazemetostat
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15
  2. description
    Blood samples were collected at specified timepoints. Cmax accumulation ratio was assessed using non-compartmental data analysis method. Cmax accumulation ratio was calculated as the ratio of Cmax at steady state (Cycle 1 Day 15) divided by Cmax during the initial dosing interval (Cycle 1 Day 1).
    measure
    Part 1: Least Squares Geometric Mean Ratio of Cmax Accumulation Ratio for Tazemetostat
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8,12, 36, 48 post-dose on Cycle 1 Day 1, and 72 hours post-dose on Cycle 1 Day 15
  3. description
    Blood samples were collected at specified timepoints. Drug-drug interaction was assessed using analysis of variance (ANOVA).
    measure
    Part 1: Least Squares Geometric Mean Ratio of AUC0-12h After Single Dose of Tazemetostat With Itraconazole
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 1 (without itraconazole) and Cycle 1 Day 21 (with itraconazole)
  4. description
    Blood samples were collected at specified timepoints. Drug-drug interaction was assessed using ANOVA.
    measure
    Part 1: Least Squares Geometric Mean Ratio of Cmax After Single Dose of Tazemetostat With Itraconazole
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose on Cycle 1 Day 1 (without itraconazole) and Cycle 1 Day 21 (with itraconazole)
  5. description
    Blood samples were collected at specified timepoints. Drug-drug interaction was assessed using ANOVA.
    measure
    Part 1: Least Squares Geometric Mean Ratio of AUC0-12h After Tazemetostat at Steady-State With Itraconazole
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 15 (without itraconazole) and Cycle 1 Day 36 (with itraconazole)
  6. description
    Blood samples were collected at specified timepoints. Drug-drug interaction was assessed using ANOVA.
    measure
    Part 1: Least Squares Geometric Mean Ratio of Cmax After Tazemetostat at Steady-State With Itraconazole
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 36, and 72 hours post-dose on Cycle 1 Day 15 (without itraconazole) and Cycle 1 Day 36 (with itraconazole)
  7. description
    Blood samples were collected at specified timepoints. AUC0-12h accumulation ratio was assessed using non-compartmental data analysis method. AUC0-12h accumulation ratio was calculated as the ratio of AUC0-12h at steady state (Cycle 1 Day 15) divided by AUC0-12h during the initial dosing interval (Cycle 1 Day 1).
    measure
    Part 2: Least Squares Geometric Mean Ratio of Observed Accumulation Ratio of AUC0-12h for Tazemetostat
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8,12, 24, 36, and 48 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15
  8. description
    Blood samples were collected at specified timepoints. Cmax accumulation ratio was assessed using non-compartmental data analysis method. Cmax accumulation ratio was calculated as the ratio of Cmax at steady state (Cycle 1 Day 15) divided by Cmax during the initial dosing interval (Cycle 1 Day 1).
    measure
    Part 2: Least Squares Geometric Mean Ratio of Cmax Accumulation Ratio for Tazemetostat
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8,12, 24, 36, and 48 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15
  9. description
    Blood samples were collected at specified timepoints. Drug-drug interaction was assessed using ANOVA.
    measure
    Part 2: Least Squares Geometric Mean Ratio of AUC0-12h After Tazemetostat at Steady State With Rifampin
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 15 (without rifampin) and Cycle 1 Day 24 (with rifampin)
  10. description
    Blood samples were collected at specified timepoints. Drug-drug interaction was assessed using ANOVA.
    measure
    Part 2: Least Squares Geometric Mean Ratio of Cmax After Tazemetostat at Steady State With Rifampin
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose on Cycle 1 Day 15 (without rifampin) and Cycle 1 Day 24 (with rifampin)
primary Outcomes
  1. description
    Blood samples were collected at specified timepoints. AUC0-12h was assessed using non-compartmental data analysis method. AUC0-12h was estimated by a combination of linear trapezoidal method on concentrations going up and logarithmic trapezoidal method on concentrations going down (Linear up/Log down method).
    measure
    Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours of Quantifiable Concentration (AUC0-12h) of Tazemetostat
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15
  2. description
    Blood samples were collected at specified timepoints. Cmax was assessed using non-compartmental data analysis method.
    measure
    Part 1: Maximum Observed Plasma Concentration (Cmax) of Tazemetostat
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 36, 48, and 72 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15
  3. description
    Blood samples were collected at specified timepoints. AUC0-12h was assessed using non-compartmental data analysis method. AUC0-12h was estimated by a combination of linear trapezoidal method on concentrations going up and logarithmic trapezoidal method on concentrations going down (Linear up/Log down method).
    measure
    Part 2: AUC0-12h of Tazemetostat
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15
  4. description
    Blood samples were collected at specified timepoints. Cmax was assessed using non-compartmental data analysis method.
    measure
    Part 2: Cmax of Tazemetostat
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15
secondary Outcomes
  1. description
    Blood samples were collected at specified timepoints. AUC0-12h was assessed using non-compartmental data analysis method. AUC0-12h was estimated by a combination of linear trapezoidal method on concentrations going up and logarithmic trapezoidal method on concentrations going down (Linear up/Log down method).
    measure
    Part 1: AUC0-12h of EPZ-6930 After Tazemetostat Alone at Steady-State
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 15
  2. description
    Blood samples were collected at specified timepoints. AUC0-12h was assessed using non-compartmental data analysis method. AUC0-12h was estimated by a combination of linear trapezoidal method on concentrations going up and logarithmic trapezoidal method on concentrations going down (Linear up/Log down method).
    measure
    Part 1: AUC0-12h of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Itraconazole
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 36
  3. description
    Blood samples were collected at specified timepoints. Cmax was assessed using non-compartmental data analysis method.
    measure
    Part 1: Cmax of EPZ-6930 After Tazemetostat Alone at Steady-State
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 36, and 72 hours post-dose on Cycle 1 Day 15
  4. description
    Blood samples were collected at specified timepoints. Cmax was assessed using non-compartmental data analysis method.
    measure
    Part 1: Cmax of Tazemetostat and EPZ-6930 After Tazemetostat at Steady State With Itraconazole
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 36, and 72 hours post-dose on Cycle 1 Day 36
  5. description
    Blood samples were collected at specified timepoints. Tmax was assessed using non-compartmental data analysis method.
    measure
    Part 1: Observed Time at Cmax (Tmax) of Tazemetostat and EPZ-6930 After Tazemetostat Alone at Steady-State
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 36, and 72 hours post-dose on Cycle 1 Day 15
  6. description
    Blood samples were collected at specified timepoints. Tmax was assessed using non-compartmental data analysis method.
    measure
    Part 1: Tmax of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Itraconazole
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 36, and 72 hours post-dose on Cycle 1 Day 36
  7. description
    Blood samples were collected at specified timepoints. T1/2 was assessed using non-compartmental data analysis method.
    measure
    Part 1: Apparent Terminal Elimination Half-Life (t1/2) of Tazemetostat and EPZ-6930 After Tazemetostat Alone at Steady-State
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 36, and 72 hours post-dose on Cycle 1 Day 15
  8. description
    Blood samples were collected at specified timepoints. T1/2 was assessed using non-compartmental data analysis method.
    measure
    Part 1: T1/2 of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Itraconazole
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 36, and 72 hours post-dose on Cycle 1 Day 36
  9. description
    Blood samples were collected at specified timepoints. AUC0-12h was assessed using non-compartmental data analysis method. AUC0-12h was estimated by a combination of linear trapezoidal method on concentrations going up and logarithmic trapezoidal method on concentrations going down (Linear up/Log down method).
    measure
    Part 2: AUC0-12h of EPZ-6930 After Tazemetostat Alone at Steady-State
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 15
  10. description
    Blood samples were collected at specified timepoints. AUC0-12h was assessed using non-compartmental data analysis method. AUC0-12h was estimated by a combination of linear trapezoidal method on concentrations going up and logarithmic trapezoidal method on concentrations going down (Linear up/Log down method).
    measure
    Part 2: AUC0-12h of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Rifampin
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 24
  11. description
    Blood samples were collected at specified timepoints. Cmax was assessed using non-compartmental data analysis method.
    measure
    Part 2: Cmax of EPZ-6930 After Tazemetostat Alone at Steady-State
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose on Cycle 1 Day 15
  12. description
    Blood samples were collected at specified timepoints. Cmax was assessed using non-compartmental data analysis method.
    measure
    Part 2: Cmax of Tazemetostat and EPZ-6930 After Tazemetostat at Steady State With Rifampin
    time Frame
    Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours post-dose on Cycle 1 Day 24
Full study description
brief Summary
The participants of this study will have advanced malignancies (also known as advanced cancer). The main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the tazemtostat (the study drug) when administered in combination with another drug. Part 1 of the study will evaluate the interaction between the drugs tazemetostat and itraconazole. Part 2 of the study will evaluate the interaction between the drugs tazemetostat and rifampin For both Parts 1 and 2, safety and the level that effects of the study drug can be tolerated (known as tolerability) will be assessed throughout.
detailed Description
This two-part study is designed to characterize the steady-state PK of oral tazemetostat and its metabolite EPZ 6930 when administered as a single and twice daily dose in subjects with advanced malignancies while taken alone or in combination with either itraconazole or rifampin. Part 1: tazemetostat and Itraconazole Drug Interaction Part 1 of the study will evaluate the drug-drug interaction between tazemetostat and itraconazole in an open-label, fixed sequential cross over design. Part 2: tazemetostat and Rifampin Drug Interaction Part 2 of the study will evaluate the drug-drug interaction between tazemetostat and rifampin in an open-label, fixed sequential cross over design. For both Parts 1 and 2, safety and tolerability will be assessed throughout the subject's participation. Subjects must have an end of study visit after 30 days of the last dose of tazemetostat for safety assessment.
Source references
Source notices and limitations
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