TriangleNCT00697346 · OUTCOME
Best Overall Response Rate Based on Investigator's Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- 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
Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using 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.
Analysis population: The response-evaluable population is defined as all participants who received at least 1 dose of alisertib and have measurable disease at baseline and have at least 1 post baseline response assessment.
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 | 23 |
| Part 1: ECT Dose Escalation | 23 |
| Part 2: PTCL | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PIC Dose Escalation | 13 | Not reported | Not reported | Not reported | Not reported |
| Part 1: ECT Dose Escalation | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2: PTCL | 100 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using 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.
- 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
- NUMBER
- population Description
- The response-evaluable population is defined as all participants who received at least 1 dose of alisertib and have measurable disease at baseline and have at least 1 post baseline response assessment.
- 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
- Best Overall Response Rate Based on Investigator's Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice