TriangleNCT02014116 · OUTCOME
Maximum Tolerated Dose (MTD) of LY3009120
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- milligrams (mg)
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 (28 Days)
What was measured
Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
Analysis population: All participants in Part A who received at least one dose of study drug.
Groups in this outcome
Part A LY3009120
Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.
| Group | Source count |
|---|---|
| Part A LY3009120 | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A LY3009120 | 300 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 300
- denoms
- counts
- group Id
- OG000
- value
- 35
- units
- Participants
- description
- Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
- groups
- description
- Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.
- id
- OG000
- title
- Part A LY3009120
- param Type
- NUMBER
- population Description
- All participants in Part A who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (28 Days)
- title
- Maximum Tolerated Dose (MTD) of LY3009120
- type
- PRIMARY
- unit Of Measure
- milligrams (mg)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice