TriangleNCT00112723 · OUTCOME
Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- patients
- Interval / dispersion
- Not reported
- Time frame
- 28 days
What was measured
Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.
Groups in this outcome
Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)
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.
Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)
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.
Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)
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 (Flavopiridol 30 mg/m2 + 30 mg/m2) | 11 |
| Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) | 19 |
| Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2) | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2) | 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
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 14
- units
- Participants
- description
- Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.
- 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.
- id
- OG000
- title
- Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)
- 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
- Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)
- 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
- Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 28 days
- title
- Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)
- type
- PRIMARY
- unit Of Measure
- patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice