TriangleNCT02171260 · OUTCOME
Number of Participants With Best Overall Response
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
- First dose of study drug (Baseline) up to approximately Cycle 8 (21-days treatment cycle)
What was measured
Best Overall Response (BOR): best response recorded from start of study treatment until disease progression (PD) or recurrence based on response evaluation criteria in solid tumors (RECIST) version 1.1 for target and non-target lesions. Participants with evaluable disease were also eligible for assessment.
Analysis population: The SAS included all participants who received at least one dose of study drug.
Groups in this outcome
Part A1: Eribulin Mesylate 1.1 mg/m^2
Participants received eribulin mesylate 1.1 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
Part A1: Eribulin Mesylate 1.4 mg/m^2
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
Part A1: Eribulin Mesylate 1.8 mg/m2
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
Part A1: Eribulin Mesylate PK Expansion
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
| Group | Source count |
|---|---|
| Part A1: Eribulin Mesylate 1.1 mg/m^2 | 6 |
| Part A1: Eribulin Mesylate 1.4 mg/m^2 | 6 |
| Part A1: Eribulin Mesylate 1.8 mg/m2 | 5 |
| Part A1: Eribulin Mesylate PK Expansion | 5 |
Reported measurements
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A1: Eribulin Mesylate 1.1 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate 1.4 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate 1.8 mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate PK Expansion | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A1: Eribulin Mesylate 1.1 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate 1.4 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate 1.8 mg/m2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A1: Eribulin Mesylate PK Expansion | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Partial Response
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- Best Overall Response (BOR): best response recorded from start of study treatment until disease progression (PD) or recurrence based on response evaluation criteria in solid tumors (RECIST) version 1.1 for target and non-target lesions. Participants with evaluable disease were also eligible for assessment.
- groups
- description
- Participants received eribulin mesylate 1.1 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
- id
- OG000
- title
- Part A1: Eribulin Mesylate 1.1 mg/m^2
- description
- Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
- id
- OG001
- title
- Part A1: Eribulin Mesylate 1.4 mg/m^2
- description
- Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
- id
- OG002
- title
- Part A1: Eribulin Mesylate 1.8 mg/m2
- description
- Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
- id
- OG003
- title
- Part A1: Eribulin Mesylate PK Expansion
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The SAS included all participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- First dose of study drug (Baseline) up to approximately Cycle 8 (21-days treatment cycle)
- title
- Number of Participants With Best Overall Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice