TriangleNCT03037385 · OUTCOME
Phase 1: Percent Change From Baseline in Sprout Receptor Tyrosine Kinase Signaling Antagonist 4 (SPRY4)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Week 4
What was measured
The dose dependent change in a MAPK pathway expression signature was analyzed for all available samples of MTC and NSCLC participants. Participants with archived sample (used as baseline) and on treatment Cycle 2 Day 1 (1 cycle = 28 days) tumor tissues with greater than 20% tumor cells are included in the analysis. The changes in tumor biomarker SPRY4 levels was explored.
Analysis population: Safety Population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels.
Groups in this outcome
Phase I: Pralsetinib 30 mg
Participants received pralsetinib 30 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 60 mg
Participants received pralsetinib 60 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 100 mg
Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 200 mg
Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 300 mg
Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 400 mg
Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 600 mg
Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 100/100 mg
Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 200/100 mg
Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons.
| Group | Source count |
|---|---|
| Phase I: Pralsetinib 30 mg | 2 |
| Phase I: Pralsetinib 60 mg | 6 |
| Phase I: Pralsetinib 100 mg | 5 |
| Phase I: Pralsetinib 200 mg | 13 |
| Phase I: Pralsetinib 300 mg | 11 |
| Phase I: Pralsetinib 400 mg | 12 |
| Phase I: Pralsetinib 600 mg | 4 |
| Phase I: Pralsetinib 100/100 mg | 5 |
| Phase I: Pralsetinib 200/100 mg | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Pralsetinib 30 mg | 0 | 0 | Not reported | Not reported | Not reported |
| Phase I: Pralsetinib 60 mg | 210.16 | 309.468 | Not reported | Not reported | Not reported |
| Phase I: Pralsetinib 100 mg | 0 | 0 | Not reported | Not reported | Not reported |
| Phase I: Pralsetinib 200 mg | -34.98 | 29.569 | Not reported | Not reported | Not reported |
| Phase I: Pralsetinib 300 mg | -69.00 | 28.731 | Not reported | Not reported | Not reported |
| Phase I: Pralsetinib 400 mg | -3.26 | 99.349 | Not reported | Not reported | Not reported |
| Phase I: Pralsetinib 600 mg | 0 | 0 | Not reported | Not reported | Not reported |
| Phase I: Pralsetinib 100/100 mg | -75.65 | 10.944 | Not reported | Not reported | Not reported |
| Phase I: Pralsetinib 200/100 mg | 124.93 | 311.210 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 0
- group Id
- OG001
- spread
- 309.468
- value
- 210.16
- group Id
- OG002
- spread
- 0
- value
- 0
- group Id
- OG003
- spread
- 29.569
- value
- -34.98
- group Id
- OG004
- spread
- 28.731
- value
- -69.00
- group Id
- OG005
- spread
- 99.349
- value
- -3.26
- group Id
- OG006
- spread
- 0
- value
- 0
- group Id
- OG007
- spread
- 10.944
- value
- -75.65
- group Id
- OG008
- spread
- 311.210
- value
- 124.93
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 12
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 4
- units
- Participants
- description
- The dose dependent change in a MAPK pathway expression signature was analyzed for all available samples of MTC and NSCLC participants. Participants with archived sample (used as baseline) and on treatment Cycle 2 Day 1 (1 cycle = 28 days) tumor tissues with greater than 20% tumor cells are included in the analysis. The changes in tumor biomarker SPRY4 levels was explored.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received pralsetinib 30 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG000
- title
- Phase I: Pralsetinib 30 mg
- description
- Participants received pralsetinib 60 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG001
- title
- Phase I: Pralsetinib 60 mg
- description
- Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG002
- title
- Phase I: Pralsetinib 100 mg
- description
- Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG003
- title
- Phase I: Pralsetinib 200 mg
- description
- Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG004
- title
- Phase I: Pralsetinib 300 mg
- description
- Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG005
- title
- Phase I: Pralsetinib 400 mg
- description
- Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG006
- title
- Phase I: Pralsetinib 600 mg
- description
- Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG007
- title
- Phase I: Pralsetinib 100/100 mg
- description
- Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG008
- title
- Phase I: Pralsetinib 200/100 mg
- param Type
- MEAN
- population Description
- Safety Population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 4
- title
- Phase 1: Percent Change From Baseline in Sprout Receptor Tyrosine Kinase Signaling Antagonist 4 (SPRY4)
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice