TriangleNCT03547700 · OUTCOME
Count of Participants Experiencing Dose Limiting Toxicities (DLTs) at Each Dose Level.
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 first dose of treatment through the 1st cycle (28 days)
What was measured
A DLT is defined as any of the following adverse events (AEs) that are possibly, probably, or definitely related to the combination of ixazomib and romidepsin that occurs during the 1st cycle. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4 will be used. * Grade 4 Neutropenia \>=14 days * Febrile neutropenia: Grade 3 or 4 neutropenia with fever ˃ 38ºC, both sustained over a 24-hour period * Anemia Grade 3/4 * Thrombocytopenia: Grade ≥ 4 lasting greater than 7 days or Grade ≥ 3 complicated by at least a Grade 2 hemorrhage * Grade 3/4 Non-Hematologic Toxicities. (excluding alopecia, fatigue or anorexia lasting ˂ 7 days, or Grade 3 nausea and/or vomiting that persists for ˂ 2 days following appropriate supportive care). Nausea, vomiting, or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy * Grade 3/4 Infection * Any Grade 5 events * Grade ≥ 3 electrolyte abnormalities that do not resolve to ≤Grade 2 or baselinewithin 7 days
Groups in this outcome
Phase I Dose Level 4:Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 10mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
| Group | Source count |
|---|---|
| Phase I Dose Level 4:Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15 | 1 |
| Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15 | 9 |
| Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Level 4:Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- A DLT is defined as any of the following adverse events (AEs) that are possibly, probably, or definitely related to the combination of ixazomib and romidepsin that occurs during the 1st cycle. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4 will be used. * Grade 4 Neutropenia \>=14 days * Febrile neutropenia: Grade 3 or 4 neutropenia with fever ˃ 38ºC, both sustained over a 24-hour period * Anemia Grade 3/4 * Thrombocytopenia: Grade ≥ 4 lasting greater than 7 days or Grade ≥ 3 complicated by at least a Grade 2 hemorrhage * Grade 3/4 Non-Hematologic Toxicities. (excluding alopecia, fatigue or anorexia lasting ˂ 7 days, or Grade 3 nausea and/or vomiting that persists for ˂ 2 days following appropriate supportive care). Nausea, vomiting, or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy * Grade 3/4 Infection * Any Grade 5 events * Grade ≥ 3 electrolyte abnormalities that do not resolve to ≤Grade 2 or baselinewithin 7 days
- groups
- description
- Romidepsin 10mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
- id
- OG000
- title
- Phase I Dose Level 4:Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
- description
- Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
- id
- OG001
- title
- Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15
- description
- Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
- id
- OG002
- title
- Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From first dose of treatment through the 1st cycle (28 days)
- title
- Count of Participants Experiencing Dose Limiting Toxicities (DLTs) at Each Dose Level.
- type
- POST_HOC
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice