TriangleNCT01677858 · OUTCOME
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)
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
- 28 days
What was measured
The MTD was defined as the highest carfilzomib dose at which \< 33% of participants had a treatment-related DLT during the first 28-day cycle. A DLT was categorized as nonhematologic or hematologic and defined as follows: Nonhematologic: * ≥ grade 3 nonhematological toxicity (excluding nausea, vomiting, diarrhea, fatigue lasting \< 14 days, increased serum creatinine or electrolyte abnormalities not clinically significant or requiring treatment) * ≥ grade 3 acute kidney injury (creatinine \> 3 x baseline or \> 4.0 mg/dL) lasting \> 72 hours * ≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/mm³) for \> 7 days * febrile neutropenia (ANC \< 1000/mm³ with a fever ≥ 38.3ºC) of any duration * grade 4 thrombocytopenia (\< 25 000/mm³) for \> 14 days, despite holding treatment * grade 3 or 4 thrombocytopenia (\< lower limit of normal) associated with \> grade 1 bleeding
Analysis population: Participants in phase 1 who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Groups in this outcome
Phase 1 Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
| Group | Source count |
|---|---|
| Phase 1 Carfilzomib 45 mg/m² | 3 |
| Phase 1: Carfilzomib 56 mg/m² | 3 |
| Phase 1: Carfilzomib 70 mg/m² | 15 |
| Phase 1: Carfilzomib 88 mg/m² | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Carfilzomib 45 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 56 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 70 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 88 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- OG002
- OG003
- non Inferiority Type
- OTHER
- param Type
- Maximum Tolerated Dose (mg/m²)
- param Value
- 70
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- OG002
- OG003
- non Inferiority Type
- OTHER
- param Type
- Maximum Tolerated Dose (mg/m²)
- param Value
- 70
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- The MTD was defined as the highest carfilzomib dose at which \< 33% of participants had a treatment-related DLT during the first 28-day cycle. A DLT was categorized as nonhematologic or hematologic and defined as follows: Nonhematologic: * ≥ grade 3 nonhematological toxicity (excluding nausea, vomiting, diarrhea, fatigue lasting \< 14 days, increased serum creatinine or electrolyte abnormalities not clinically significant or requiring treatment) * ≥ grade 3 acute kidney injury (creatinine \> 3 x baseline or \> 4.0 mg/dL) lasting \> 72 hours * ≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/mm³) for \> 7 days * febrile neutropenia (ANC \< 1000/mm³ with a fever ≥ 38.3ºC) of any duration * grade 4 thrombocytopenia (\< 25 000/mm³) for \> 14 days, despite holding treatment * grade 3 or 4 thrombocytopenia (\< lower limit of normal) associated with \> grade 1 bleeding
- groups
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
- id
- OG000
- title
- Phase 1 Carfilzomib 45 mg/m²
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
- id
- OG001
- title
- Phase 1: Carfilzomib 56 mg/m²
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
- id
- OG002
- title
- Phase 1: Carfilzomib 70 mg/m²
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
- id
- OG003
- title
- Phase 1: Carfilzomib 88 mg/m²
- param Type
- NUMBER
- population Description
- Participants in phase 1 who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
- reporting Status
- POSTED
- time Frame
- 28 days
- title
- Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice