TriangleNCT01063907 · OUTCOME
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- 21 day cycle, up to 52 weeks
What was measured
The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses. The ORR, was defined as the best response over a specified number of cycles (calculated and summarized). Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized).
Analysis population: All subjects who received at least 1 dose, including a partial dose, of KW-2478 were evaluated for safety.
Groups in this outcome
Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine. The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m\^2) and Bortezomib (1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts. The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
| Group | Source count |
|---|---|
| Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 95 |
| Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2 | 3 |
| Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2 | 3 |
| Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2 | 3 |
| Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 6 |
| Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 80 |
Reported measurements
Subjects with Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 95 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 80 | Not reported | Not reported | Not reported | Not reported |
Related TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 88 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 74 | Not reported | Not reported | Not reported | Not reported |
Moderate (CTCAE 2) TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 22 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 22 | Not reported | Not reported | Not reported | Not reported |
Severe (CTCAE 3) TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 54 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 42 | Not reported | Not reported | Not reported | Not reported |
Life Threatening TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 13 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 12 | Not reported | Not reported | Not reported | Not reported |
Serious Treatment-Emergent AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 48 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 36 | Not reported | Not reported | Not reported | Not reported |
Subjects with Any DLT
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 80
- title
- Subjects with Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 74
- title
- Related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 22
- title
- Moderate (CTCAE 2) TEAE
- categories
- measurements
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 42
- title
- Severe (CTCAE 3) TEAE
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 12
- title
- Life Threatening TEAE
- categories
- measurements
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 36
- title
- Serious Treatment-Emergent AE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Subjects with Any DLT
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 80
- units
- Participants
- description
- The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses. The ORR, was defined as the best response over a specified number of cycles (calculated and summarized). Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized).
- groups
- description
- The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine. The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m\^2) and Bortezomib (1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts. The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
- id
- OG000
- title
- Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
- description
- Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
- id
- OG001
- title
- Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
- description
- Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
- id
- OG002
- title
- Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
- description
- Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
- id
- OG003
- title
- Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
- description
- Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
- id
- OG004
- title
- Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
- description
- Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
- id
- OG005
- title
- Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
- param Type
- NUMBER
- population Description
- All subjects who received at least 1 dose, including a partial dose, of KW-2478 were evaluated for safety.
- reporting Status
- POSTED
- time Frame
- 21 day cycle, up to 52 weeks
- title
- To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
- type
- PRIMARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice