TriangleNCT01496118 · OUTCOME
Number of Phase I Patients (Dose Level 1-6) Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage
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
- 28 days from the start of study treatment
What was measured
Using a traditional 3+3 dose escalation design, successive cohorts of subjects will receive a fixed dose level of the drug combination. The MTD is defined as the highest dose level at which ≤1 of 6 subjects experiences a dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.0. DLT is defined as any of the following that are determined to be related to study treatment during Cycle 1: Grade 4 neutropenia for \>7 days, Febrile neutropenia, Grade 3 thrombocytopenia with ≥ Grade 2 bleeding, Grade 4 thrombocytopenia \> 7 days, ≥ Grade 2 neuropathy with uncontrolled pain, ≥ Grade 3 non-hematologic drug-related toxicity (excluding alopecia), despite optimal supportive care lasting \>72 hours or requiring a dose reduction in the first cycle and Patients who are unable to receive 75% of the required doses of both agents secondary to toxicity. Number of Participants With such Dose Limiting Toxicities (DLT) at each level are reported here.
Analysis population: Includes all Phase 1 patients receiving assigned study dosing
Groups in this outcome
Dose Level 1
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
Dose Level 2
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
Dose Level 3
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
Dose Level 4
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
Dose Level 5
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
Dose Level 6
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
| Group | Source count |
|---|---|
| Dose Level 1 | 4 |
| Dose Level 2 | 3 |
| Dose Level 3 | 3 |
| Dose Level 4 | 3 |
| Dose Level 5 | 3 |
| Dose Level 6 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 6 | 0 | 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
- 0
- group Id
- OG005
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- Using a traditional 3+3 dose escalation design, successive cohorts of subjects will receive a fixed dose level of the drug combination. The MTD is defined as the highest dose level at which ≤1 of 6 subjects experiences a dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.0. DLT is defined as any of the following that are determined to be related to study treatment during Cycle 1: Grade 4 neutropenia for \>7 days, Febrile neutropenia, Grade 3 thrombocytopenia with ≥ Grade 2 bleeding, Grade 4 thrombocytopenia \> 7 days, ≥ Grade 2 neuropathy with uncontrolled pain, ≥ Grade 3 non-hematologic drug-related toxicity (excluding alopecia), despite optimal supportive care lasting \>72 hours or requiring a dose reduction in the first cycle and Patients who are unable to receive 75% of the required doses of both agents secondary to toxicity. Number of Participants With such Dose Limiting Toxicities (DLT) at each level are reported here.
- groups
- description
- Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 27 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 27 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
- id
- OG000
- title
- Dose Level 1
- description
- Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 36 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 36 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
- id
- OG001
- title
- Dose Level 2
- description
- Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
- id
- OG002
- title
- Dose Level 3
- description
- Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
- id
- OG003
- title
- Dose Level 4
- description
- Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
- id
- OG004
- title
- Dose Level 5
- description
- Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19 panobinostat: Specified dose on specified days carfilzomib: Specified dose on specified days
- id
- OG005
- title
- Dose Level 6
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Includes all Phase 1 patients receiving assigned study dosing
- reporting Status
- POSTED
- time Frame
- 28 days from the start of study treatment
- title
- Number of Phase I Patients (Dose Level 1-6) Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice