TriangleNCT04211337 · OUTCOME
Treatment Failure-Free Survival (TFFS) by Blinded Independent Committee Review (BICR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause Up to 39 Months
What was measured
TFFS by BICR is defined as the time from randomization to the first occurrence of: * documented radiographic disease progression per RECIST 1.1 as assessed by BICR; or * unacceptable toxicity leading to treatment discontinuation as assessed by the investigator. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. To qualify as an event, the toxicity must be from an intolerable AE (defined as any study drug-related AE that meets protocol guidance for treatment discontinuation, with the exception of alopecia); or death (due to any cause).
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. Censored participants: Selpercatinib - 166; Cabozantinib or Vandetanib - 61
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) | NA | Not reported | NA | NA | Data not available due to high censoring. |
| Cabozantinib or Vandetanib (TRT B) | 13.93 | Not reported | 11.27 | 25.10 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.153
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.423
- estimate Comment
- Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.254
- statistical Comment
- Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.153
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.423
- estimate Comment
- Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.254
- statistical Comment
- Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Data not available due to high censoring.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 11.27
- upper Limit
- 25.10
- value
- 13.93
- denoms
- counts
- group Id
- OG000
- value
- 193
- group Id
- OG001
- value
- 98
- units
- Participants
- description
- TFFS by BICR is defined as the time from randomization to the first occurrence of: * documented radiographic disease progression per RECIST 1.1 as assessed by BICR; or * unacceptable toxicity leading to treatment discontinuation as assessed by the investigator. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. To qualify as an event, the toxicity must be from an intolerable AE (defined as any study drug-related AE that meets protocol guidance for treatment discontinuation, with the exception of alopecia); or death (due to any cause).
- 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
- MEDIAN
- 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. Censored participants: Selpercatinib - 166; Cabozantinib or Vandetanib - 61
- reporting Status
- POSTED
- time Frame
- Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause Up to 39 Months
- title
- Treatment Failure-Free Survival (TFFS) by Blinded Independent Committee Review (BICR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice