TriangleNCT02119468 · OUTCOME
Number of Patients With Dose-Limiting Toxicities (Phase I)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the initial treatment to Day 28 (Cycle #1)
What was measured
Dose Limiting Toxicity (DLT) is defined as any of the toxicities in Section 7.3 that are at least possibly related to either Pomalidomide or MLN9708 that occur during cycle 1. Toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.03. The highest dose level that produces 1/6 dose-limiting toxicities (DLTs) in course 1 will be the maximum tolerated dose (MTD). The RP2D of ixazomib and pomalidomide will generally be the MTD, but it may be less than the MTD based on a review of available data/cumulative toxicities from phase I.
Analysis population: Patients were considered evaluable for DLT if receiving at least 75% of both Pomalidomide and MLN9708 and followed for the full 28 days during cycle 1 or experience a DLT. All patients who are not evaluable for DLT were replaced.
Groups in this outcome
Dose Level #1: 3mg MLN9708
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Dose Level #2: 4mg MLN9708
Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Dose Level #1: 3mg MLN9708 | 6 |
| Dose Level #2: 4mg MLN9708 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level #1: 3mg MLN9708 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level #2: 4mg MLN9708 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Dose Limiting Toxicity (DLT) is defined as any of the toxicities in Section 7.3 that are at least possibly related to either Pomalidomide or MLN9708 that occur during cycle 1. Toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.03. The highest dose level that produces 1/6 dose-limiting toxicities (DLTs) in course 1 will be the maximum tolerated dose (MTD). The RP2D of ixazomib and pomalidomide will generally be the MTD, but it may be less than the MTD based on a review of available data/cumulative toxicities from phase I.
- groups
- description
- Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Dose Level #1: 3mg MLN9708
- description
- Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Dose Level #2: 4mg MLN9708
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Patients were considered evaluable for DLT if receiving at least 75% of both Pomalidomide and MLN9708 and followed for the full 28 days during cycle 1 or experience a DLT. All patients who are not evaluable for DLT were replaced.
- reporting Status
- POSTED
- time Frame
- From the initial treatment to Day 28 (Cycle #1)
- title
- Number of Patients With Dose-Limiting Toxicities (Phase I)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice