TriangleNCT00697346 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Baseline and every 2 cycles up to Month 12 until disease progression, 30 days after end of treatment (up to 422 days)
What was measured
DOR is defined as the time from the date of first documentation of a response (either CR or PR) to the date of first documentation of progressive disease (PD) according to International Working Group (IWG) criteria. CR is defined as the disappearance of all evidence of disease and the definition for PR includes at least a 50% decrease in sum of the product of the diameters and no new lesions. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
Analysis population: Participants from the Response-Evaluable Population who had a response of CR or PR.
Groups in this outcome
Part 1: PIC Dose Escalation
Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
Part 1: ECT Dose Escalation
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
Part 2: PTCL
Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
| Group | Source count |
|---|---|
| Part 1: PIC Dose Escalation | 3 |
| Part 1: ECT Dose Escalation | 2 |
| Part 2: PTCL | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PIC Dose Escalation | 0.03 | Not reported | 0.03 | 3.65 | Not reported |
| Part 1: ECT Dose Escalation | 2.07 | Not reported | 0.03 | 4.18 | Not reported |
| Part 2: PTCL | 0.03 | Not reported | 0.03 | 0.03 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- upper Limit
- 3.65
- value
- 0.03
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 4.18
- value
- 2.07
- group Id
- OG002
- lower Limit
- 0.03
- upper Limit
- 0.03
- value
- 0.03
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- DOR is defined as the time from the date of first documentation of a response (either CR or PR) to the date of first documentation of progressive disease (PD) according to International Working Group (IWG) criteria. CR is defined as the disappearance of all evidence of disease and the definition for PR includes at least a 50% decrease in sum of the product of the diameters and no new lesions. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
- dispersion Type
- Full Range
- groups
- description
- Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
- id
- OG000
- title
- Part 1: PIC Dose Escalation
- description
- Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
- id
- OG001
- title
- Part 1: ECT Dose Escalation
- description
- Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
- id
- OG002
- title
- Part 2: PTCL
- param Type
- MEDIAN
- population Description
- Participants from the Response-Evaluable Population who had a response of CR or PR.
- reporting Status
- POSTED
- time Frame
- Baseline and every 2 cycles up to Month 12 until disease progression, 30 days after end of treatment (up to 422 days)
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice