TriangleNCT03837899 · OUTCOME
Dose-Expansion Phase: T½λz of Durvalumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- days
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 8, and 12
What was measured
Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.
Analysis population: The PK analysis set included all participants who received at least 1 dose of study treatment per the CSP for whom any post-dose data were available who did not violate or deviate from the CSP in ways that would significantly affect the PK analysis. Only data from the participants analyzed were reported.
Groups in this outcome
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
| Group | Source count |
|---|---|
| SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 8 |
| STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 17.4 | 26.2 | Not reported | Not reported | Not reported |
| STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 14.2 | 48.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 26.2
- value
- 17.4
- group Id
- OG001
- spread
- 48.6
- value
- 14.2
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
- id
- OG000
- title
- SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
- description
- Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
- id
- OG001
- title
- STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK analysis set included all participants who received at least 1 dose of study treatment per the CSP for whom any post-dose data were available who did not violate or deviate from the CSP in ways that would significantly affect the PK analysis. Only data from the participants analyzed were reported.
- reporting Status
- POSTED
- time Frame
- Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 8, and 12
- title
- Dose-Expansion Phase: T½λz of Durvalumab
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice