TriangleNCT03899792 · OUTCOME
Phase 2: Percentage of Participants With Overall Response Rate (ORR) in Study
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
- Not reported
- Time frame
- Date of first dose to disease progression or death (Up to 62.4 Months)
What was measured
ORR: Percentage of participants who achieve best overall response Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Analysis population: All participants who received at least one dose of study drug.
Groups in this outcome
Cohort 1 (Phase 2): MTC Group
Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
Cohort 2 (Phase 2): PTC Group
Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
Cohort 3 (Phase 2): Other Cancer Group
Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
| Group | Source count |
|---|---|
| Cohort 1 (Phase 2): MTC Group | 15 |
| Cohort 2 (Phase 2): PTC Group | 15 |
| Cohort 3 (Phase 2): Other Cancer Group | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Phase 2): MTC Group | 60.0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 (Phase 2): PTC Group | 53.3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 (Phase 2): Other Cancer Group | 33.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 60.0
- group Id
- OG001
- value
- 53.3
- group Id
- OG002
- value
- 33.3
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- ORR: Percentage of participants who achieve best overall response Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
- groups
- description
- Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
- id
- OG000
- title
- Cohort 1 (Phase 2): MTC Group
- description
- Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
- id
- OG001
- title
- Cohort 2 (Phase 2): PTC Group
- description
- Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle. The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
- id
- OG002
- title
- Cohort 3 (Phase 2): Other Cancer Group
- param Type
- NUMBER
- population Description
- All participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Date of first dose to disease progression or death (Up to 62.4 Months)
- title
- Phase 2: Percentage of Participants With Overall Response Rate (ORR) in Study
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice