TriangleNCT01736683 · OUTCOME
Pharmacokinetic Parameters of Sotatercept: Serum Concentration at Various Study Timepoints
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day 8 and !5 up to Cycle 2 Day 1
What was measured
Maximum observed serum concentration, obtained directly from the observed concentration versus time data.
Analysis population: Pharmacokinetic (PK) population includes participants with a sufficient amount of post-dose quantifiable PK sotatercept profile.
Groups in this outcome
Sotatercept 0.1 mg/kg
Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
Sotatercept 0.3 mg/kg
Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
Sotatercept 0.5 mg/kg
Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/ kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
Sotatercept 1.0 mg/kg
Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/ kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
Sotatercept 2.0 mg/kg
Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 7 |
| Sotatercept 0.3 mg/kg | 6 |
| Sotatercept 0.5 mg/kg | 21 |
| Sotatercept 1.0 mg/kg | 35 |
| Sotatercept 2.0 mg/kg | 5 |
Reported measurements
Cycle 1 Day 8
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 7 |
| Sotatercept 0.3 mg/kg | 6 |
| Sotatercept 0.5 mg/kg | 21 |
| Sotatercept 1.0 mg/kg | 34 |
| Sotatercept 2.0 mg/kg | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.1 mg/kg | 288.06 | 70.94 | Not reported | Not reported | Not reported |
| Sotatercept 0.3 mg/kg | 1426.00 | 27.76 | Not reported | Not reported | Not reported |
| Sotatercept 0.5 mg/kg | 2237.46 | 40.77 | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 6525.37 | 28.31 | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 12886.14 | 30.47 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 6 |
| Sotatercept 0.3 mg/kg | 6 |
| Sotatercept 0.5 mg/kg | 21 |
| Sotatercept 1.0 mg/kg | 33 |
| Sotatercept 2.0 mg/kg | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.1 mg/kg | 240.31 | 75.32 | Not reported | Not reported | Not reported |
| Sotatercept 0.3 mg/kg | 1207.68 | 16.14 | Not reported | Not reported | Not reported |
| Sotatercept 0.5 mg/kg | 1869.52 | 36.97 | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 5149.74 | 36.04 | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 8303.73 | 43.57 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 6 |
| Sotatercept 0.3 mg/kg | 6 |
| Sotatercept 0.5 mg/kg | 20 |
| Sotatercept 1.0 mg/kg | 35 |
| Sotatercept 2.0 mg/kg | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.1 mg/kg | 252.20 | 28.43 | Not reported | Not reported | Not reported |
| Sotatercept 0.3 mg/kg | 957.58 | 18.63 | Not reported | Not reported | Not reported |
| Sotatercept 0.5 mg/kg | 1323.91 | 44.40 | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 3467.58 | 57.06 | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 5329.63 | 38.27 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 70.94
- value
- 288.06
- group Id
- OG001
- spread
- 27.76
- value
- 1426.00
- group Id
- OG002
- spread
- 40.77
- value
- 2237.46
- group Id
- OG003
- spread
- 28.31
- value
- 6525.37
- group Id
- OG004
- spread
- 30.47
- value
- 12886.14
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 34
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- Cycle 1 Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 75.32
- value
- 240.31
- group Id
- OG001
- spread
- 16.14
- value
- 1207.68
- group Id
- OG002
- spread
- 36.97
- value
- 1869.52
- group Id
- OG003
- spread
- 36.04
- value
- 5149.74
- group Id
- OG004
- spread
- 43.57
- value
- 8303.73
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 33
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 28.43
- value
- 252.20
- group Id
- OG001
- spread
- 18.63
- value
- 957.58
- group Id
- OG002
- spread
- 44.40
- value
- 1323.91
- group Id
- OG003
- spread
- 57.06
- value
- 3467.58
- group Id
- OG004
- spread
- 38.27
- value
- 5329.63
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 35
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 35
- group Id
- OG004
- value
- 5
- units
- Participants
- description
- Maximum observed serum concentration, obtained directly from the observed concentration versus time data.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
- id
- OG000
- title
- Sotatercept 0.1 mg/kg
- description
- Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
- id
- OG001
- title
- Sotatercept 0.3 mg/kg
- description
- Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/ kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
- id
- OG002
- title
- Sotatercept 0.5 mg/kg
- description
- Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/ kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
- id
- OG003
- title
- Sotatercept 1.0 mg/kg
- description
- Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.
- id
- OG004
- title
- Sotatercept 2.0 mg/kg
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK) population includes participants with a sufficient amount of post-dose quantifiable PK sotatercept profile.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 8 and !5 up to Cycle 2 Day 1
- title
- Pharmacokinetic Parameters of Sotatercept: Serum Concentration at Various Study Timepoints
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice