TriangleNCT00112736 · OUTCOME
Pharmacokinetics (Phase I)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Days 1, 2 of cycle 1, prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration
What was measured
Tersirolimus Cmax (ng/mL) for cycle 1 is presented in the outcome measure table below for the 3 dose levels blood samples (5ml) was collected in EDTA containing tubes on days 1 and 2 of cycle 1 Collection time points: prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration
Analysis population: per protocol
Groups in this outcome
Phase 1 - 15mg
PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
Phase 1 - 25 mg
Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
Phase 1 - 50mg
Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase 1 - 15mg | 11 |
| Phase 1 - 25 mg | 6 |
| Phase 1 - 50mg | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 - 15mg | 460 | 219 | Not reported | Not reported | Not reported |
| Phase 1 - 25 mg | 428 | 115 | Not reported | Not reported | Not reported |
| Phase 1 - 50mg | 451 | 281 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 219
- value
- 460
- group Id
- OG001
- spread
- 115
- value
- 428
- group Id
- OG002
- spread
- 281
- value
- 451
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- Tersirolimus Cmax (ng/mL) for cycle 1 is presented in the outcome measure table below for the 3 dose levels blood samples (5ml) was collected in EDTA containing tubes on days 1 and 2 of cycle 1 Collection time points: prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration
- dispersion Type
- Standard Deviation
- groups
- description
- PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Phase 1 - 15mg
- description
- Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Phase 1 - 25 mg
- description
- Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
- id
- OG002
- title
- Phase 1 - 50mg
- param Type
- MEAN
- population Description
- per protocol
- reporting Status
- POSTED
- time Frame
- Days 1, 2 of cycle 1, prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration
- title
- Pharmacokinetics (Phase I)
- type
- PRIMARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice