TriangleNCT03717415 · OUTCOME
PK: Area Under the Concentration-time Curve 0-3 Hours (AUC 0-3 Hours) (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 hour per milliliter (ng*h/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
Measure the AUC 0-3 hours
Analysis population: Part 1 participants who received any study drug and had evaluable AUC 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 | 186 | 153 | Not reported | Not reported | Not reported |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 150 | 125 | Not reported | Not reported | Not reported |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 230 | 116 | 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 | 380 | 88.3 | Not reported | Not reported | Not reported |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | 262 | 103 | Not reported | Not reported | Not reported |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | 369 | 98.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 153
- value
- 186
- group Id
- OG001
- spread
- 125
- value
- 150
- group Id
- OG002
- spread
- 116
- value
- 230
- 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
- 88.3
- value
- 380
- group Id
- OG001
- spread
- 103
- value
- 262
- group Id
- OG002
- spread
- 98.7
- value
- 369
- 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
- Measure the AUC 0-3 hours
- 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 AUC data at each timepoint.
- reporting Status
- POSTED
- time Frame
- Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
- title
- PK: Area Under the Concentration-time Curve 0-3 Hours (AUC 0-3 Hours) (Part 1)
- type
- SECONDARY
- unit Of Measure
- Nanograms hour per milliliter (ng*h/mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice