TriangleNCT00932698 · OUTCOME
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
Analysis population: PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.
Groups in this outcome
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
| Group | Source count |
|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 3 |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 3 |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 2 |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 2 |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 3 |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 6 |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 3 |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 17 |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 9 |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 6 |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 1 |
Reported measurements
Day 1
| Group | Source count |
|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 3 |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 2 |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 2 |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 2 |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 3 |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 6 |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 3 |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 14 |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 9 |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 6 |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 1.000 | Not reported | 0.57 | 2.00 | Not reported |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 1.000 | Not reported | 0.50 | 1.50 | Not reported |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 0.775 | Not reported | 0.55 | 1.00 | Not reported |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 0.775 | Not reported | 0.50 | 1.05 | Not reported |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 1.000 | Not reported | 1.00 | 2.02 | Not reported |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 1.000 | Not reported | 0.25 | 1.08 | Not reported |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 1.000 | Not reported | 0.72 | 1.08 | Not reported |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 1.000 | Not reported | 0.52 | 2.00 | Not reported |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0.617 | Not reported | 0.50 | 3.97 | Not reported |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 0.525 | Not reported | 0.25 | 1.05 | Not reported |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 1.000 | Not reported | 1.00 | 1.00 | Not reported |
Day 11
| Group | Source count |
|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 3 |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 3 |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 2 |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 2 |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 3 |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 5 |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 2 |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 14 |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 7 |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 5 |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 1.100 | Not reported | 1.05 | 4.07 | Not reported |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 1.000 | Not reported | 0.50 | 1.17 | Not reported |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 1.275 | Not reported | 0.55 | 2.00 | Not reported |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 0.500 | Not reported | 0.50 | 0.50 | Not reported |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 1.000 | Not reported | 0.57 | 1.05 | Not reported |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 0.667 | Not reported | 0.50 | 1.50 | Not reported |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 0.832 | Not reported | 0.53 | 1.13 | Not reported |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 1.010 | Not reported | 0.50 | 23.60 | Not reported |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0.583 | Not reported | 0.50 | 1.03 | Not reported |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 1.500 | Not reported | 0.62 | 1.53 | Not reported |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 1.500 | Not reported | 1.5 | 1.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.57
- upper Limit
- 2.00
- value
- 1.000
- group Id
- OG001
- lower Limit
- 0.50
- upper Limit
- 1.50
- value
- 1.000
- group Id
- OG002
- lower Limit
- 0.55
- upper Limit
- 1.00
- value
- 0.775
- group Id
- OG003
- lower Limit
- 0.50
- upper Limit
- 1.05
- value
- 0.775
- group Id
- OG004
- lower Limit
- 1.00
- upper Limit
- 2.02
- value
- 1.000
- group Id
- OG005
- lower Limit
- 0.25
- upper Limit
- 1.08
- value
- 1.000
- group Id
- OG006
- lower Limit
- 0.72
- upper Limit
- 1.08
- value
- 1.000
- group Id
- OG007
- lower Limit
- 0.52
- upper Limit
- 2.00
- value
- 1.000
- group Id
- OG008
- lower Limit
- 0.50
- upper Limit
- 3.97
- value
- 0.617
- group Id
- OG009
- lower Limit
- 0.25
- upper Limit
- 1.05
- value
- 0.525
- group Id
- OG010
- lower Limit
- 1.00
- upper Limit
- 1.00
- value
- 1.000
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 1
- units
- Participants
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.05
- upper Limit
- 4.07
- value
- 1.100
- group Id
- OG001
- lower Limit
- 0.50
- upper Limit
- 1.17
- value
- 1.000
- group Id
- OG002
- lower Limit
- 0.55
- upper Limit
- 2.00
- value
- 1.275
- group Id
- OG003
- lower Limit
- 0.50
- upper Limit
- 0.50
- value
- 0.500
- group Id
- OG004
- lower Limit
- 0.57
- upper Limit
- 1.05
- value
- 1.000
- group Id
- OG005
- lower Limit
- 0.50
- upper Limit
- 1.50
- value
- 0.667
- group Id
- OG006
- lower Limit
- 0.53
- upper Limit
- 1.13
- value
- 0.832
- group Id
- OG007
- lower Limit
- 0.50
- upper Limit
- 23.60
- value
- 1.010
- group Id
- OG008
- lower Limit
- 0.50
- upper Limit
- 1.03
- value
- 0.583
- group Id
- OG009
- lower Limit
- 0.62
- upper Limit
- 1.53
- value
- 1.500
- group Id
- OG010
- lower Limit
- 1.5
- upper Limit
- 1.5
- value
- 1.500
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 7
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 1
- units
- Participants
- title
- Day 11
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 17
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 1
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
- id
- OG000
- title
- Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
- description
- Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
- id
- OG001
- title
- Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
- description
- Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
- id
- OG002
- title
- Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
- description
- Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
- id
- OG003
- title
- Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
- description
- Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
- id
- OG004
- title
- Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
- id
- OG005
- title
- Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
- description
- Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
- id
- OG006
- title
- Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
- id
- OG007
- title
- Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
- id
- OG008
- title
- Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.
- id
- OG009
- title
- Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
- id
- OG010
- title
- Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
- param Type
- MEDIAN
- population Description
- PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.
- reporting Status
- POSTED
- time Frame
- Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
- title
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice