TriangleNCT00932698 · OUTCOME
CL/F: Blood Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Ixazomib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
What was measured
CL/F is apparent clearance of the drug from the plasma.
Analysis population: CL/F was not reported as this PK parameter could not be calculated.
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 | 0 |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 0 |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 0 |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 0 |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 0 |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 0 |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 0 |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 0 |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- units
- Participants
- description
- CL/F is apparent clearance of the drug from the plasma.
- 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
- population Description
- CL/F was not reported as this PK parameter could not be calculated.
- reporting Status
- POSTED
- time Frame
- Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
- title
- CL/F: Blood Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Ixazomib
- type
- SECONDARY
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Preserved source evidence · Not medical advice