TriangleNCT04211337 · OUTCOME
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR
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
- Baseline through Disease Progression or Death Up to 39 Months
What was measured
ORR is defined as the number of participants who achieved the best overall response (BOR) of CR or PR divided by the total number of participants randomized to each treatment arm. ORR per RECIST 1.1 as assessed by BICR.
Analysis population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.
Groups in this outcome
Selpercatinib (TRT A)
160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
Cabozantinib or Vandetanib (TRT B)
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: * 0.7 - \<0.9 - 100 mg every other day (QOD) * 0.9 - \<1.2 - 100 mg QD * 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg * ≥1.6 - 200 QD
| Group | Source count |
|---|---|
| Selpercatinib (TRT A) | 193 |
| Cabozantinib or Vandetanib (TRT B) | 98 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Selpercatinib (TRT A) | 69.4 | Not reported | 62.4 | 75.8 | Not reported |
| Cabozantinib or Vandetanib (TRT B) | 38.8 | Not reported | 29.1 | 49.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 2.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.3
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib)
- param Type
- Odds Ratio (OR)
- param Value
- 3.7
- statistical Method
- Clopper-Pearson method
Complete source fields
- analyses
- ci Lower Limit
- 2.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.3
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib)
- param Type
- Odds Ratio (OR)
- param Value
- 3.7
- statistical Method
- Clopper-Pearson method
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 62.4
- upper Limit
- 75.8
- value
- 69.4
- group Id
- OG001
- lower Limit
- 29.1
- upper Limit
- 49.2
- value
- 38.8
- denoms
- counts
- group Id
- OG000
- value
- 193
- group Id
- OG001
- value
- 98
- units
- Participants
- description
- ORR is defined as the number of participants who achieved the best overall response (BOR) of CR or PR divided by the total number of participants randomized to each treatment arm. ORR per RECIST 1.1 as assessed by BICR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
- id
- OG000
- title
- Selpercatinib (TRT A)
- description
- 140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: * 0.7 - \<0.9 - 100 mg every other day (QOD) * 0.9 - \<1.2 - 100 mg QD * 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg * ≥1.6 - 200 QD
- id
- OG001
- title
- Cabozantinib or Vandetanib (TRT B)
- param Type
- NUMBER
- population Description
- All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.
- reporting Status
- POSTED
- time Frame
- Baseline through Disease Progression or Death Up to 39 Months
- title
- Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice