TriangleNCT03037385 · OUTCOME
Phase 1: ORR
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 28 months
What was measured
ORR was defined as the percentage of participants with a confirmed CR or PR for at least two assessments with at least 28 days apart and no PD in between. Per RECIST v1.1, CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). ORR and its two-sided 95% CI, based on the exact binomial distribution (Clopper-Pearson), was presented.
Analysis population: Efficacy population included all participants who have been exposed to at least one dose of the study drug on or prior to 11 July 2019.
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 | Not reported | NA | NA | The 95% confidence interval (CI) was not estimable due to insufficient number of participants with events. |
| Phase I: Pralsetinib 60 mg | 50.0 | Not reported | 11.8 | 88.2 | Not reported |
| Phase I: Pralsetinib 100 mg | 40.0 | Not reported | 5.3 | 85.3 | Not reported |
| Phase I: Pralsetinib 200 mg | 38.5 | Not reported | 13.9 | 68.4 | Not reported |
| Phase I: Pralsetinib 300 mg | 45.5 | Not reported | 16.7 | 76.6 | Not reported |
| Phase I: Pralsetinib 400 mg | 41.7 | Not reported | 15.2 | 72.3 | Not reported |
| Phase I: Pralsetinib 600 mg | 25.0 | Not reported | 0.99 | 80.6 | Not reported |
| Phase I: Pralsetinib 100/100 mg | 80.0 | Not reported | 28.4 | 99.5 | Not reported |
| Phase I: Pralsetinib 200/100 mg | 75.0 | Not reported | 19.4 | 99.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG001
- lower Limit
- 11.8
- upper Limit
- 88.2
- value
- 50.0
- group Id
- OG002
- lower Limit
- 5.3
- upper Limit
- 85.3
- value
- 40.0
- group Id
- OG003
- lower Limit
- 13.9
- upper Limit
- 68.4
- value
- 38.5
- group Id
- OG004
- lower Limit
- 16.7
- upper Limit
- 76.6
- value
- 45.5
- group Id
- OG005
- lower Limit
- 15.2
- upper Limit
- 72.3
- value
- 41.7
- group Id
- OG006
- lower Limit
- 0.99
- upper Limit
- 80.6
- value
- 25.0
- group Id
- OG007
- lower Limit
- 28.4
- upper Limit
- 99.5
- value
- 80.0
- group Id
- OG008
- lower Limit
- 19.4
- upper Limit
- 99.4
- value
- 75.0
- 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
- ORR was defined as the percentage of participants with a confirmed CR or PR for at least two assessments with at least 28 days apart and no PD in between. Per RECIST v1.1, CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). ORR and its two-sided 95% CI, based on the exact binomial distribution (Clopper-Pearson), was presented.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- Efficacy population included all participants who have been exposed to at least one dose of the study drug on or prior to 11 July 2019.
- reporting Status
- POSTED
- time Frame
- Up to approximately 28 months
- title
- Phase 1: ORR
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice