TriangleNCT02082977 · OUTCOME
Part 1: Number of Participants With Overall Change in Tri-methylated Histone H3 Lysine 27 (H3K27me3) Ratios Compared to Baseline
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline and up to 3.2 years
What was measured
The pre and post-treatment samples for tumor or surrogate tissue/body fluid (e.g. Peripheral blood mononuclear cell \[PBMCs\], blood, skin or hair) were collected for the analysis of H3K27me3. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was defined as any visit value minus Baseline value.
Analysis population: Pharmacodynamic Population
Groups in this outcome
Part 1:GSK2816126 50 mg Twice-weekly
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 100 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 200 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 400 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 800 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 1200 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 1800 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 2400 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 3000 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
| Group | Source count |
|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 2 |
| Part 1:GSK2816126 100 mg Twice-weekly | 1 |
| Part 1:GSK2816126 200 mg Twice-weekly | 1 |
| Part 1:GSK2816126 400 mg Twice-weekly | 1 |
| Part 1:GSK2816126 800 mg Twice-weekly | 3 |
| Part 1:GSK2816126 1200 mg Twice-weekly | 4 |
| Part 1:GSK2816126 1800 mg Twice-weekly | 10 |
| Part 1:GSK2816126 2400 mg Twice-weekly | 12 |
| Part 1:GSK2816126 3000 mg Twice-weekly | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 100 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 200 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 400 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 800 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1200 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1800 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 2400 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 3000 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 7
- units
- Participants
- description
- The pre and post-treatment samples for tumor or surrogate tissue/body fluid (e.g. Peripheral blood mononuclear cell \[PBMCs\], blood, skin or hair) were collected for the analysis of H3K27me3. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was defined as any visit value minus Baseline value.
- groups
- description
- Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG000
- title
- Part 1:GSK2816126 50 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG001
- title
- Part 1:GSK2816126 100 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG002
- title
- Part 1:GSK2816126 200 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG003
- title
- Part 1:GSK2816126 400 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG004
- title
- Part 1:GSK2816126 800 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG005
- title
- Part 1:GSK2816126 1200 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG006
- title
- Part 1:GSK2816126 1800 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG007
- title
- Part 1:GSK2816126 2400 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG008
- title
- Part 1:GSK2816126 3000 mg Twice-weekly
- param Type
- NUMBER
- population Description
- Pharmacodynamic Population
- reporting Status
- POSTED
- time Frame
- Baseline and up to 3.2 years
- title
- Part 1: Number of Participants With Overall Change in Tri-methylated Histone H3 Lysine 27 (H3K27me3) Ratios Compared to Baseline
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice