TriangleNCT00555906 · OUTCOME
Time to Tumor Progression (TTP): Phase 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib
What was measured
TTP was defined as the time from first dose of study medication to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\] per IMWGURC). PD: \>=25% increase from lowest response level in serum M-component or urine M-component, \>=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.
Analysis population: RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.
Groups in this outcome
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
| Group | Source count |
|---|---|
| Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B) | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B) | 3.9 | Not reported | 1.4 | 7.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 7.4
- value
- 3.9
- denoms
- counts
- group Id
- OG000
- value
- 30
- units
- Participants
- description
- TTP was defined as the time from first dose of study medication to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\] per IMWGURC). PD: \>=25% increase from lowest response level in serum M-component or urine M-component, \>=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
- id
- OG000
- title
- Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)
- param Type
- MEDIAN
- population Description
- RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib
- title
- Time to Tumor Progression (TTP): Phase 2
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice