NCT03031730 · OUTCOME
Evaluate Safety and Tolerability of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Dose Limiting Toxicity
- Interval / dispersion
- Not reported
- Time frame
- at least 6 months of treatment, an average of 1 year
Analysis population: Only included DLT-evaluable patients. 6 of 6 patients enrolled on Dose Level 1 and 5 of 10 patients at dose level 2 were DLT-evaluable. Therefore, the primary outcome of determining the safety and tolerability beyond dose level one was not possible, and the MTD and recommended phase 2 dose could not be evaluated prior to study closure.
Groups in this outcome
Part A: Dose Level 1
KRT-232 60 mg + KRd
Part A: Dose Level 2
KRT-232 90 mg + KRd
| Group | Source count |
|---|---|
| Part A: Dose Level 1 | 6 |
| Part A: Dose Level 2 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Dose Level 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A: Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- units
- Participants
- groups
- description
- KRT-232 60 mg + KRd
- id
- OG000
- title
- Part A: Dose Level 1
- description
- KRT-232 90 mg + KRd
- id
- OG001
- title
- Part A: Dose Level 2
- param Type
- NUMBER
- population Description
- Only included DLT-evaluable patients. 6 of 6 patients enrolled on Dose Level 1 and 5 of 10 patients at dose level 2 were DLT-evaluable. Therefore, the primary outcome of determining the safety and tolerability beyond dose level one was not possible, and the MTD and recommended phase 2 dose could not be evaluated prior to study closure.
- reporting Status
- POSTED
- time Frame
- at least 6 months of treatment, an average of 1 year
- title
- Evaluate Safety and Tolerability of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomdie, and Dexamethasone (KRd)
- type
- PRIMARY
- unit Of Measure
- Dose Limiting Toxicity
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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