TriangleNCT05047536 · OUTCOME
Progression-free Survival of Participants Treated With KZR-261
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 4 months and 6 months
What was measured
The number of participants with progression-free survival (PFS), defined as the date of initiation of study treatment to the date of documented PD or death from any cause, whichever occurs first, at 4 months and 6 months. PFS is based on the number of subjects in each group in the response evaluable population at the specific timepoints (4 or 6 months).
Analysis population: The Response Evaluable Population is defined as all subjects who receive at least 1 dose of study treatment (KZR-261) and who have a baseline and at least 1 post-baseline anti-tumor response assessment. For participants who have neither progressed nor died, PFS is censored at the date of the last disease assessment. PFS at 4 months and 6 months are defined as subjects alive and progression-free at 4 months and at 6 months, respectively, after the initiation of study treatment.
Groups in this outcome
Dose 1
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 2
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 3
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 4
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 5
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 6
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 7
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 8
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Dose 9
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
Melanoma Expansion Cohort
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
| Group | Source count |
|---|---|
| Dose 1 | 2 |
| Dose 2 | 2 |
| Dose 3 | 2 |
| Dose 4 | 5 |
| Dose 5 | 4 |
| Dose 6 | 5 |
| Dose 7 | 5 |
| Dose 8 | 14 |
| Dose 9 | 6 |
| Melanoma Expansion Cohort | 6 |
Reported measurements
4 Months
| Group | Source count |
|---|---|
| Dose 1 | 2 |
| Dose 2 | 2 |
| Dose 3 | 2 |
| Dose 4 | 5 |
| Dose 5 | 4 |
| Dose 6 | 4 |
| Dose 7 | 5 |
| Dose 8 | 14 |
| Dose 9 | 6 |
| Melanoma Expansion Cohort | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 5 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose 6 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose 7 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose 8 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Melanoma Expansion Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
6 Months
| Group | Source count |
|---|---|
| Dose 1 | 2 |
| Dose 2 | 2 |
| Dose 3 | 2 |
| Dose 4 | 5 |
| Dose 5 | 4 |
| Dose 6 | 3 |
| Dose 7 | 5 |
| Dose 8 | 14 |
| Dose 9 | 6 |
| Melanoma Expansion Cohort | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 5 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 7 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Melanoma Expansion Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 6
- units
- Participants
- title
- 4 Months
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 6
- units
- Participants
- title
- 6 Months
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 6
- units
- Participants
- description
- The number of participants with progression-free survival (PFS), defined as the date of initiation of study treatment to the date of documented PD or death from any cause, whichever occurs first, at 4 months and 6 months. PFS is based on the number of subjects in each group in the response evaluable population at the specific timepoints (4 or 6 months).
- groups
- description
- Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG000
- title
- Dose 1
- description
- Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG001
- title
- Dose 2
- description
- Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG002
- title
- Dose 3
- description
- Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG003
- title
- Dose 4
- description
- Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG004
- title
- Dose 5
- description
- Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG005
- title
- Dose 6
- description
- Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG006
- title
- Dose 7
- description
- Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG007
- title
- Dose 8
- description
- Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG008
- title
- Dose 9
- description
- Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
- id
- OG009
- title
- Melanoma Expansion Cohort
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Response Evaluable Population is defined as all subjects who receive at least 1 dose of study treatment (KZR-261) and who have a baseline and at least 1 post-baseline anti-tumor response assessment. For participants who have neither progressed nor died, PFS is censored at the date of the last disease assessment. PFS at 4 months and 6 months are defined as subjects alive and progression-free at 4 months and at 6 months, respectively, after the initiation of study treatment.
- reporting Status
- POSTED
- time Frame
- 4 months and 6 months
- title
- Progression-free Survival of Participants Treated With KZR-261
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice