NCT00112723 · OUTCOME
Maximum Tolerated Dose (MTD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/m2
- Interval / dispersion
- Not reported
- Time frame
- 28 days
What was measured
The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.
Groups in this outcome
Dose Level 1 (30+30)
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
Level 2 (30+50)
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
Level 3 (50+50)
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
| Group | Source count |
|---|---|
| Dose Level 1 (30+30) | 11 |
| Level 2 (30+50) | 12 |
| Level 3 (50+50) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 (30+30) | 60 | Not reported | Not reported | Not reported | Not reported |
| Level 2 (30+50) | 80 | Not reported | Not reported | Not reported | Not reported |
| Level 3 (50+50) | 100 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 12
- units
- Participants
- description
- The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.
- groups
- description
- PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
- id
- OG000
- title
- Dose Level 1 (30+30)
- description
- PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
- id
- OG001
- title
- Level 2 (30+50)
- description
- PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
- id
- OG002
- title
- Level 3 (50+50)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 28 days
- title
- Maximum Tolerated Dose (MTD)
- type
- PRIMARY
- unit Of Measure
- mg/m2
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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