TriangleNCT03717415 · OUTCOME
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Nanograms per milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
What was measured
Cmax of rebastinib
Analysis population: Part 1 participants who received any study drug and had evaluable Cmax data at each timepoint.
Groups in this outcome
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | 3 |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 13 |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 3 |
Reported measurements
C1 D1
| Group | Source count |
|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | 3 |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 13 |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | 92.2 | 157 | Not reported | Not reported | Not reported |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 120 | 106 | Not reported | Not reported | Not reported |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 144 | 103 | Not reported | Not reported | Not reported |
C2 D1
| Group | Source count |
|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | 3 |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 8 |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | 190 | 106 | Not reported | Not reported | Not reported |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 151 | 67.8 | Not reported | Not reported | Not reported |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 323 | 18.2 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 157
- value
- 92.2
- group Id
- OG001
- spread
- 106
- value
- 120
- group Id
- OG002
- spread
- 103
- value
- 144
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 3
- units
- Participants
- title
- C1 D1
- categories
- measurements
- group Id
- OG000
- spread
- 106
- value
- 190
- group Id
- OG001
- spread
- 67.8
- value
- 151
- group Id
- OG002
- spread
- 18.2
- value
- 323
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 3
- units
- Participants
- title
- C2 D1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- Cmax of rebastinib
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
- id
- OG000
- title
- Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
- description
- Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
- id
- OG001
- title
- Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
- description
- Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
- id
- OG002
- title
- Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
- param Type
- GEOMETRIC_MEAN
- population Description
- Part 1 participants who received any study drug and had evaluable Cmax data at each timepoint.
- reporting Status
- POSTED
- time Frame
- Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
- title
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
- type
- SECONDARY
- unit Of Measure
- Nanograms per milliliter (ng/mL)
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Preserved source evidence · Not medical advice