TriangleNCT03037385 · OUTCOME
Phase 2: Tlast
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days)
What was measured
The maximum values for Tlast slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol.
Analysis population: PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Groups in this outcome
RET- Fusion Positive NSCLC Participants
Participants who had RET-fusion positive NSCLC received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.
Tumor-agnostic Participants
Participants who had RET-fusion positive NSCLC or TC, or RET-mutation positive MTC, each with different genetic mutations received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.
RET-altered Solid Tumors Participants
Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.
RET-mutation Positive Tumors Other Than MTC Participants
Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.
| Group | Source count |
|---|---|
| RET- Fusion Positive NSCLC Participants | 98 |
| Tumor-agnostic Participants | 5 |
| RET-altered Solid Tumors Participants | 3 |
| RET-mutation Positive Tumors Other Than MTC Participants | 4 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| RET- Fusion Positive NSCLC Participants | 98 |
| Tumor-agnostic Participants | 5 |
| RET-altered Solid Tumors Participants | 3 |
| RET-mutation Positive Tumors Other Than MTC Participants | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RET- Fusion Positive NSCLC Participants | 23.9 | Not reported | 2.40 | 24.8 | Not reported |
| Tumor-agnostic Participants | 8.00 | Not reported | 7.8 | 23.5 | Not reported |
| RET-altered Solid Tumors Participants | 23.10 | Not reported | 8.0 | 24.0 | Not reported |
| RET-mutation Positive Tumors Other Than MTC Participants | 8.05 | Not reported | 8.0 | 24.0 | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| RET- Fusion Positive NSCLC Participants | 87 |
| Tumor-agnostic Participants | 5 |
| RET-altered Solid Tumors Participants | 3 |
| RET-mutation Positive Tumors Other Than MTC Participants | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RET- Fusion Positive NSCLC Participants | 23.8 | Not reported | 7.80 | 26.5 | Not reported |
| Tumor-agnostic Participants | 23.70 | Not reported | 7.9 | 24.0 | Not reported |
| RET-altered Solid Tumors Participants | 24.00 | Not reported | 7.9 | 24.0 | Not reported |
| RET-mutation Positive Tumors Other Than MTC Participants | 24.00 | Not reported | 23.8 | 24.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.40
- upper Limit
- 24.8
- value
- 23.9
- group Id
- OG001
- lower Limit
- 7.8
- upper Limit
- 23.5
- value
- 8.00
- group Id
- OG002
- lower Limit
- 8.0
- upper Limit
- 24.0
- value
- 23.10
- group Id
- OG003
- lower Limit
- 8.0
- upper Limit
- 24.0
- value
- 8.05
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.80
- upper Limit
- 26.5
- value
- 23.8
- group Id
- OG001
- lower Limit
- 7.9
- upper Limit
- 24.0
- value
- 23.70
- group Id
- OG002
- lower Limit
- 7.9
- upper Limit
- 24.0
- value
- 24.00
- group Id
- OG003
- lower Limit
- 23.8
- upper Limit
- 24.0
- value
- 24.00
- denoms
- counts
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- units
- Participants
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- units
- Participants
- description
- The maximum values for Tlast slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol.
- dispersion Type
- Full Range
- groups
- description
- Participants who had RET-fusion positive NSCLC received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.
- id
- OG000
- title
- RET- Fusion Positive NSCLC Participants
- description
- Participants who had RET-fusion positive NSCLC or TC, or RET-mutation positive MTC, each with different genetic mutations received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.
- id
- OG001
- title
- Tumor-agnostic Participants
- description
- Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.
- id
- OG002
- title
- RET-altered Solid Tumors Participants
- description
- Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data.
- id
- OG003
- title
- RET-mutation Positive Tumors Other Than MTC Participants
- param Type
- MEDIAN
- population Description
- PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days)
- title
- Phase 2: Tlast
- type
- SECONDARY
- unit Of Measure
- hours
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Preserved source evidence · Not medical advice