TriangleNCT00888927 · OUTCOME
Maximum Tolerated Dose
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
- 6 weeks
What was measured
The objective was to find the maximum tolerated dose (MTD). In the dose escalation phase (Phase 1), the starting dose was 0.1 mg/kg administered intravenously once every week for four weeks, followed by a 2-week observation period in the first treatment course. Succeeding dose levels included 0.3 and 1.0 mg/kg. Standard 3+3 cohorts for safety and DLT detection were utilized. Each cohort consisted of at least three subjects. If Dose-Limiting Toxicity (DLT) was observed in 0/3 subjects, escalation to the next dose level occurred.
Analysis population: Safety Analysis set - Included all subjects who received at least one dose of KW-0761 (even a partial dose)
Groups in this outcome
Phase 1 Cohort 1
First course: 0.1 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.1 mg/kg over 1 hour every other week KW-0761: The starting dose will be 0.1 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met.
Phase 1 Cohort 2
First course: 0.3 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.3 mg/kg over 1 hour every other week KW-0761: The starting dose will be 0.3 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met.
Phase 1 Cohort 3
First course: 1.0 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 1.0 mg/kg over 1 hour every other week KW-0761: The starting dose will be 1.0 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met.
Phase 2
First course: Maximum tolerated dose once a week over 1 hour for 4 weeks Subsequent courses: Maximum tolerated dose over 1 hour every other week If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met.
| Group | Source count |
|---|---|
| Phase 1 Cohort 1 | 3 |
| Phase 1 Cohort 2 | 3 |
| Phase 1 Cohort 3 | 3 |
| Phase 2 | 33 |
Reported measurements
Subjects with any Dose-Limiting Toxicity (DLT)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 0 | Not reported | Not reported | Not reported | Not reported |
Subjects with any treatment emergent adverse event (TEAE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 32 | Not reported | Not reported | Not reported | Not reported |
Subjects with any treatment-emergent serious adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 8 | Not reported | Not reported | Not reported | Not reported |
Subjects with any TEAE(s) leading to discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 7 | 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
- title
- Subjects with any Dose-Limiting Toxicity (DLT)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 32
- title
- Subjects with any treatment emergent adverse event (TEAE)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 8
- title
- Subjects with any treatment-emergent serious adverse event
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 7
- title
- Subjects with any TEAE(s) leading to discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 33
- units
- Participants
- description
- The objective was to find the maximum tolerated dose (MTD). In the dose escalation phase (Phase 1), the starting dose was 0.1 mg/kg administered intravenously once every week for four weeks, followed by a 2-week observation period in the first treatment course. Succeeding dose levels included 0.3 and 1.0 mg/kg. Standard 3+3 cohorts for safety and DLT detection were utilized. Each cohort consisted of at least three subjects. If Dose-Limiting Toxicity (DLT) was observed in 0/3 subjects, escalation to the next dose level occurred.
- groups
- description
- First course: 0.1 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.1 mg/kg over 1 hour every other week KW-0761: The starting dose will be 0.1 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met.
- id
- OG000
- title
- Phase 1 Cohort 1
- description
- First course: 0.3 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 0.3 mg/kg over 1 hour every other week KW-0761: The starting dose will be 0.3 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met.
- id
- OG001
- title
- Phase 1 Cohort 2
- description
- First course: 1.0 mg/kg once a week over 1 hour for 4 weeks Subsequent courses: 1.0 mg/kg over 1 hour every other week KW-0761: The starting dose will be 1.0 mg/kg administered i.v. once every week for four weeks, followed by a 2-week observation period in the first treatment course. If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met.
- id
- OG002
- title
- Phase 1 Cohort 3
- description
- First course: Maximum tolerated dose once a week over 1 hour for 4 weeks Subsequent courses: Maximum tolerated dose over 1 hour every other week If a subject has demonstrated an overall CR, may continue on study for up to an additional four infusions beyond CR on an every other week infusion schedule. If a subject experiences a PR or SD, the subject may continue therapy on an every other week infusion schedule until disease progression occurs or other withdrawal criteria are met.
- id
- OG003
- title
- Phase 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis set - Included all subjects who received at least one dose of KW-0761 (even a partial dose)
- reporting Status
- POSTED
- time Frame
- 6 weeks
- title
- Maximum Tolerated Dose
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice