TriangleNCT01693562 · OUTCOME
Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase
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
- For MEDI4736 0.1 to MEDI4736 10 mg/kg arms: from Day 1 to Day 28 of first dose; for MEDI4736 15 mg/kg arm: from Day 1 to Day 42 of first dose
What was measured
A DLT was defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT-evaluation period including any \>= Grade 3 colitis or \>= Grade 3 immune-related adverse event (irAE; AEs of immune nature in the absence of a clear alternative etiology) including rash, pruritus, or diarrhea that did not downgrade to =\< Grade 2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids. The DLT-evaluation period for 0.1 to 10 mg/kg arms was from Day 1 to Day 28 of first dose and for 15 mg/kg arm was from Day 1 to Day 42 of first dose.
Analysis population: DLT-evaluable population included all participants in the dose-escalation phase who received at least 2 doses of study drug and completed safety follow-up through DLT-evaluable period or experienced any DLT during the DLT-evaluation period.
Groups in this outcome
Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)
Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)
Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first
Escalation Cohort (MEDI4736 1 mg/kg Q2W)
Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Escalation Cohort (MEDI4736 3 mg/kg Q2W)
Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
Escalation Cohort (MEDI4736 10 mg/kg Q2W)
Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
Escalation Cohort (MEDI4736 15 mg/kg Q3W)
Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
| Group | Source count |
|---|---|
| Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | 4 |
| Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | 4 |
| Escalation Cohort (MEDI4736 1 mg/kg Q2W) | 3 |
| Escalation Cohort (MEDI4736 3 mg/kg Q2W) | 3 |
| Escalation Cohort (MEDI4736 10 mg/kg Q2W) | 6 |
| Escalation Cohort (MEDI4736 15 mg/kg Q3W) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 1 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 3 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Escalation Cohort (MEDI4736 15 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 7
- units
- Participants
- description
- A DLT was defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT-evaluation period including any \>= Grade 3 colitis or \>= Grade 3 immune-related adverse event (irAE; AEs of immune nature in the absence of a clear alternative etiology) including rash, pruritus, or diarrhea that did not downgrade to =\< Grade 2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids. The DLT-evaluation period for 0.1 to 10 mg/kg arms was from Day 1 to Day 28 of first dose and for 15 mg/kg arm was from Day 1 to Day 42 of first dose.
- groups
- description
- Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG000
- title
- Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)
- description
- Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first
- id
- OG001
- title
- Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)
- description
- Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG002
- title
- Escalation Cohort (MEDI4736 1 mg/kg Q2W)
- description
- Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
- id
- OG003
- title
- Escalation Cohort (MEDI4736 3 mg/kg Q2W)
- description
- Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.
- id
- OG004
- title
- Escalation Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG005
- title
- Escalation Cohort (MEDI4736 15 mg/kg Q3W)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- DLT-evaluable population included all participants in the dose-escalation phase who received at least 2 doses of study drug and completed safety follow-up through DLT-evaluable period or experienced any DLT during the DLT-evaluation period.
- reporting Status
- POSTED
- time Frame
- For MEDI4736 0.1 to MEDI4736 10 mg/kg arms: from Day 1 to Day 28 of first dose; for MEDI4736 15 mg/kg arm: from Day 1 to Day 42 of first dose
- title
- Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice