TriangleNCT02642965 · OUTCOME
Liposome-encapsulated Cytarabine Area Under the Curve
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- (NANOGRAM x HOUR) / MILLILITER
- Interval / dispersion
- Full Range
- Time frame
- Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1
What was measured
Geometric mean liposome-encapsulated cytarabine area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration will be determined for patients in the dose-finding phase.
Analysis population: Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.
Groups in this outcome
Treatment (CPX-351 and FLAG)
COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2. COURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5.
| Group | Source count |
|---|---|
| Treatment (CPX-351 and FLAG) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (CPX-351 and FLAG) | 4418582.5 | Not reported | 2765108.0 | 6382600.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2765108.0
- upper Limit
- 6382600.0
- value
- 4418582.5
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- Geometric mean liposome-encapsulated cytarabine area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration will be determined for patients in the dose-finding phase.
- dispersion Type
- Full Range
- groups
- description
- COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2. COURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5.
- id
- OG000
- title
- Treatment (CPX-351 and FLAG)
- param Type
- GEOMETRIC_MEAN
- population Description
- Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.
- reporting Status
- POSTED
- time Frame
- Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1
- title
- Liposome-encapsulated Cytarabine Area Under the Curve
- type
- SECONDARY
- unit Of Measure
- (NANOGRAM x HOUR) / MILLILITER
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice