TriangleNCT04537715 · STUDY IN CONTEXT
Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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).
Blood samples were collected at specified timepoints. Cmax was assessed using non-compartmental data analysis method.
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).
Blood samples were collected at specified timepoints. Cmax was assessed using non-compartmental data analysis method.
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).
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).
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- trial label
- Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0000
- source section id
- NCT04537715-om-0000
- source outcome index
- 0
- endpoint
- Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours of Quantifiable Concentration (AUC0-12h) of Tazemetostat
- endpoint definition
- 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).
- time origin
- 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
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Pharmacokinetic (PK) population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 1 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or itraconazole.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0001
- source section id
- NCT04537715-om-0001
- source outcome index
- 1
- endpoint
- Part 1: Maximum Observed Plasma Concentration (Cmax) of Tazemetostat
- endpoint definition
- Blood samples were collected at specified timepoints. Cmax was assessed using non-compartmental data analysis method.
- time origin
- 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
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PK population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 1 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or itraconazole.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0002
- source section id
- NCT04537715-om-0002
- source outcome index
- 2
- endpoint
- Part 2: AUC0-12h of Tazemetostat
- endpoint definition
- 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).
- time origin
- 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
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PK population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 2 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or rifampin.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0003
- source section id
- NCT04537715-om-0003
- source outcome index
- 3
- endpoint
- Part 2: Cmax of Tazemetostat
- endpoint definition
- Blood samples were collected at specified timepoints. Cmax was assessed using non-compartmental data analysis method.
- time origin
- 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
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PK population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 2 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or rifampin.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0004
- source section id
- NCT04537715-om-0004
- source outcome index
- 4
- endpoint
- Part 1: AUC0-12h of EPZ-6930 After Tazemetostat Alone at Steady-State
- endpoint definition
- 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).
- time origin
- Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 15
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PK population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 1 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or itraconazole.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0005
- source section id
- NCT04537715-om-0005
- source outcome index
- 5
- endpoint
- Part 1: AUC0-12h of Tazemetostat and EPZ-6930 After Tazemetostat at Steady-State With Itraconazole
- endpoint definition
- 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).
- time origin
- Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose on Cycle 1 Day 36
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PK population included all participants who had sufficient PK concentration data to calculate steady-state PK parameters in Part 1 and did not have any major protocol deviation that was deemed to greatly alter the steady-state exposure to tazemetostat or itraconazole.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part 1: Tazemetostat
- regimen
- Participants received a single oral dose of 400 mg tazemetostat on Cycle 1 Day 1, BID dose of tazemetostat 400 mg on Days 3 to 14 and single dose of tazemetostat 400 mg on Day 15. From Days 21 to 35, they received a 400 mg BID dose of tazemetostat. On Cycle 1 Day 36, they received a single dose of 400 mg tazemetostat. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 40 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04537715-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part 1: Tazemetostat
- regimen
- Participants received a single oral dose of 400 mg tazemetostat on Cycle 1 Day 1, BID dose of tazemetostat 400 mg on Days 3 to 14 and single dose of tazemetostat 400 mg on Day 15. From Days 21 to 35, they received a 400 mg BID dose of tazemetostat. On Cycle 1 Day 36, they received a single dose of 400 mg tazemetostat. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 40 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04537715-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Part 2: Tazemetostat
- regimen
- Participants received a single oral dose of 800 mg tazemetostat on Cycle 1 Day 1, BID dose of 800 mg of tazemetostat from Days 3 to 14 and a single oral dose of 800 mg tazemetostat on Day 15. From Days 17 to 23, they received an 800 mg BID dose of tazemetostat. On Day 24, subjects received a single dose of 800 mg tazemetostat. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 27 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04537715-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Part 2: Tazemetostat
- regimen
- Participants received a single oral dose of 800 mg tazemetostat on Cycle 1 Day 1, BID dose of 800 mg of tazemetostat from Days 3 to 14 and a single oral dose of 800 mg tazemetostat on Day 15. From Days 17 to 23, they received an 800 mg BID dose of tazemetostat. On Day 24, subjects received a single dose of 800 mg tazemetostat. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 27 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04537715-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Part 1: Tazemetostat
- regimen
- Participants received a single oral dose of 400 mg tazemetostat on Cycle 1 Day 1, BID dose of tazemetostat 400 mg on Days 3 to 14 and single dose of tazemetostat 400 mg on Day 15. From Days 21 to 35, they received a 400 mg BID dose of tazemetostat. On Cycle 1 Day 36, they received a single dose of 400 mg tazemetostat. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 40 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04537715-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Part 1: Tazemetostat + Itraconazole
- regimen
- Participants received a single oral dose of 400 mg tazemetostat on Cycle 1 Day 1, BID dose of tazemetostat 400 mg on Days 3 to 14 and single dose of tazemetostat 400 mg on Day 15. A single oral dose of 200 mg itraconazole was administered daily from Day 18 to Day 20. From Days 21 to 35, they received a 400 mg BID dose of tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Itraconazole was also administered on Days 37 and 38 as a single oral 200 mg daily dose. On Cycle 1 Day 36, they received a single dose of 400 mg tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 40 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04537715-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- harm key
- EG000
- source section id
- NCT04537715-ae
- event group key
- EG000
- event group label
- Part 1: Tazemetostat + Itraconazole
- serious affected
- 8
- serious at risk
- 21
- other affected
- 19
- other at risk
- 21
- frequency threshold
- 5
- collection period
- Treatment-emergent adverse events and all-cause mortality were reported from the first dose of study treatment (Day 1) through 30 days after the end of study treatment (approximately 33 months).
- event definition
- The Safety population included all participants in the Enrolled population who received at least 1 dose or partial dose of the study treatments and had 1 post-dose safety observation recorded.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdoid-tumor
- nct id
- NCT04537715
- harm key
- EG001
- source section id
- NCT04537715-ae
- event group key
- EG001
- event group label
- Part 2: Tazemetostat + Rifampin
- serious affected
- 9
- serious at risk
- 21
- other affected
- 20
- other at risk
- 21
- frequency threshold
- 5
- collection period
- Treatment-emergent adverse events and all-cause mortality were reported from the first dose of study treatment (Day 1) through 30 days after the end of study treatment (approximately 33 months).
- event definition
- The Safety population included all participants in the Enrolled population who received at least 1 dose or partial dose of the study treatments and had 1 post-dose safety observation recorded.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice