TriangleNCT03157128 · OUTCOME
Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
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
- Approximately for up to 7 years 8 months
What was measured
Objective Response Rate was defined as the percentage of participants with best overall response of confirmed response (CR), or Partial response (PR). Response was confirmed by a repeat assessment no less than 28 days. * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of diameter (LD for non-nodal lesions and short axis diameter \[SAD\] for nodal lesions) of target lesions, taking as reference the baseline sum LD. ORR was assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 95% confidence interval was calculated using Clopper-Pearson method.
Analysis population: All phase 2 participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
Groups in this outcome
Phase 2, Cohort 1: RET Fusion Solid Tumor
Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Phase 2, Cohort 3: RET Mutant MTC
Participants with RET mutant medullary thyroid cancer (MTC) progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy
Participants with RET mutant MTC without prior standard first line therapy or other kinase inhibitor(s) with anti-RET activity received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Phase 2, Cohort 5: Advanced RET Altered Solid Tumor
Participants with RET altered solid tumor (cohorts 1-4, disease not measurable; MTC not eligible for Cohort 3 or 4; MTC syndrome spectrum cancer; circulating free tumor DNA \[cfDNA+\] for RET alteration not known to be present in tumor) received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants
Participants otherwise eligible for Cohorts 1-5 who discontinued other RET inhibitors received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
| Group | Source count |
|---|---|
| Phase 2, Cohort 1: RET Fusion Solid Tumor | 307 |
| Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy | 74 |
| Phase 2, Cohort 3: RET Mutant MTC | 143 |
| Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy | 116 |
| Phase 2, Cohort 5: Advanced RET Altered Solid Tumor | 201 |
| Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2, Cohort 1: RET Fusion Solid Tumor | 62.9 | Not reported | 57.2 | 68.3 | Not reported |
| Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy | 79.7 | Not reported | 68.8 | 88.2 | Not reported |
| Phase 2, Cohort 3: RET Mutant MTC | 77.6 | Not reported | 69.9 | 84.2 | Not reported |
| Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy | 82.8 | Not reported | 74.6 | 89.1 | Not reported |
| Phase 2, Cohort 5: Advanced RET Altered Solid Tumor | 57.2 | Not reported | 50.1 | 64.2 | Not reported |
| Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants | 31.3 | Not reported | 11.0 | 58.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 57.2
- upper Limit
- 68.3
- value
- 62.9
- group Id
- OG001
- lower Limit
- 68.8
- upper Limit
- 88.2
- value
- 79.7
- group Id
- OG002
- lower Limit
- 69.9
- upper Limit
- 84.2
- value
- 77.6
- group Id
- OG003
- lower Limit
- 74.6
- upper Limit
- 89.1
- value
- 82.8
- group Id
- OG004
- lower Limit
- 50.1
- upper Limit
- 64.2
- value
- 57.2
- group Id
- OG005
- lower Limit
- 11.0
- upper Limit
- 58.7
- value
- 31.3
- denoms
- counts
- group Id
- OG000
- value
- 307
- group Id
- OG001
- value
- 74
- group Id
- OG002
- value
- 143
- group Id
- OG003
- value
- 116
- group Id
- OG004
- value
- 201
- group Id
- OG005
- value
- 16
- units
- Participants
- description
- Objective Response Rate was defined as the percentage of participants with best overall response of confirmed response (CR), or Partial response (PR). Response was confirmed by a repeat assessment no less than 28 days. * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of diameter (LD for non-nodal lesions and short axis diameter \[SAD\] for nodal lesions) of target lesions, taking as reference the baseline sum LD. ORR was assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 95% confidence interval was calculated using Clopper-Pearson method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- OG000
- title
- Phase 2, Cohort 1: RET Fusion Solid Tumor
- description
- Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- OG001
- title
- Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
- description
- Participants with RET mutant medullary thyroid cancer (MTC) progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- OG002
- title
- Phase 2, Cohort 3: RET Mutant MTC
- description
- Participants with RET mutant MTC without prior standard first line therapy or other kinase inhibitor(s) with anti-RET activity received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- OG003
- title
- Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy
- description
- Participants with RET altered solid tumor (cohorts 1-4, disease not measurable; MTC not eligible for Cohort 3 or 4; MTC syndrome spectrum cancer; circulating free tumor DNA \[cfDNA+\] for RET alteration not known to be present in tumor) received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- OG004
- title
- Phase 2, Cohort 5: Advanced RET Altered Solid Tumor
- description
- Participants otherwise eligible for Cohorts 1-5 who discontinued other RET inhibitors received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- OG005
- title
- Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants
- param Type
- NUMBER
- population Description
- All phase 2 participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
- reporting Status
- POSTED
- time Frame
- Approximately for up to 7 years 8 months
- title
- Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice