TriangleNCT01942135 · OUTCOME
Ctrough for Fulvestrant
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
- Cycles 2/Day 1 and Cycle 3/Day 1
What was measured
Ctrough was defined as steady-state predose concentration. Observed directly from data. For fulvestrant, a steady-state trough was to be defined when a patient had received all prior planned doses and the sample was collected predose.
Analysis population: The 40 participants who participated in the early safety review, who are treated with palbociclib + fulvestrant ± goserelin or placebo + fulvestrant ± goserelin and have at least one measured plasma drug concentration.
Groups in this outcome
Palbociclib + Fulvestrant
Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
Placebo + Fulvestrant
Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
| Group | Source count |
|---|---|
| Palbociclib + Fulvestrant | 64 |
| Placebo + Fulvestrant | 33 |
Reported measurements
Cycle 2/Day 1
| Group | Source count |
|---|---|
| Palbociclib + Fulvestrant | 35 |
| Placebo + Fulvestrant | 19 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | 11.75 | 41 | Not reported | Not reported | Not reported |
| Placebo + Fulvestrant | 9.31 | 52 | Not reported | Not reported | Not reported |
Cycle 3/Day 1
| Group | Source count |
|---|---|
| Palbociclib + Fulvestrant | 29 |
| Placebo + Fulvestrant | 14 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | 9.90 | 42 | Not reported | Not reported | Not reported |
| Placebo + Fulvestrant | 7.60 | 72 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 41
- value
- 11.75
- group Id
- OG001
- spread
- 52
- value
- 9.31
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 19
- units
- Participants
- title
- Cycle 2/Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 42
- value
- 9.90
- group Id
- OG001
- spread
- 72
- value
- 7.60
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 14
- units
- Participants
- title
- Cycle 3/Day 1
- denoms
- counts
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 33
- units
- Participants
- description
- Ctrough was defined as steady-state predose concentration. Observed directly from data. For fulvestrant, a steady-state trough was to be defined when a patient had received all prior planned doses and the sample was collected predose.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
- id
- OG000
- title
- Palbociclib + Fulvestrant
- description
- Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
- id
- OG001
- title
- Placebo + Fulvestrant
- param Type
- GEOMETRIC_MEAN
- population Description
- The 40 participants who participated in the early safety review, who are treated with palbociclib + fulvestrant ± goserelin or placebo + fulvestrant ± goserelin and have at least one measured plasma drug concentration.
- reporting Status
- POSTED
- time Frame
- Cycles 2/Day 1 and Cycle 3/Day 1
- title
- Ctrough for Fulvestrant
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice