TriangleNCT00240162 · OUTCOME
Time to Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- Until the patient progresses or expires (up to 457 days)
What was measured
Time to progression is from the start of treatment until the first date that criteria for progressive disease (PD) are met. * 25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL and confirmed by at lease 1 repeated investigation. * 25% increase in the 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/ 24 hr and confirmed by at least 1 repeated investigation. * 35% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. * Increase in the size of existing bone lesions or soft tissue plasmacytomas * New lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression). * Hypercalcemia - corrected serum calcium \> 11.5 mg/dL
Analysis population: Participants were evaluable for time to progression if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.
Groups in this outcome
PTK787/ZK 222584
Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
| Group | Source count |
|---|---|
| PTK787/ZK 222584 | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PTK787/ZK 222584 | 149 | Not reported | 28 | 457 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28
- upper Limit
- 457
- value
- 149
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Time to progression is from the start of treatment until the first date that criteria for progressive disease (PD) are met. * 25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL and confirmed by at lease 1 repeated investigation. * 25% increase in the 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/ 24 hr and confirmed by at least 1 repeated investigation. * 35% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. * Increase in the size of existing bone lesions or soft tissue plasmacytomas * New lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression). * Hypercalcemia - corrected serum calcium \> 11.5 mg/dL
- dispersion Type
- Full Range
- groups
- description
- Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
- id
- OG000
- title
- PTK787/ZK 222584
- param Type
- MEDIAN
- population Description
- Participants were evaluable for time to progression if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.
- reporting Status
- POSTED
- time Frame
- Until the patient progresses or expires (up to 457 days)
- title
- Time to Progression
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice