TriangleNCT02669017 · OUTCOME
Overall Response Rate (ORR)
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
- Baseline to End of Study (a maximum of 18 months)
What was measured
ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with ADCT-402, before the start of subsequent anticancer therapy or procedure. Tumor response was assessed using the 2014 Lugano Classification for response. CR is defined as achieving either of the following: * Complete metabolic response. * Complete radiologic response (target node regress to \<1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). PR is defined as achieving either of the following: * Partial metabolic response (findings indicate residual disease). * Partial remission (\>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by \>50% in length and no new lesions).
Analysis population: All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment.
Groups in this outcome
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 200 μg/kg Q3W and Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 4 |
| Part 1: 90 μg/kg Q3W | 5 |
| Part 1: 120 μg/kg Q3W | 16 |
| Part 2: 120 μg/kg Q3W | 26 |
| Part 1: 150 μg/kg Q3W | 19 |
| Part 2: 150 μg/kg Q3W | 68 |
| Part 1: 200 μg/kg Q3W and Q6W | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 60 μg/kg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 90 μg/kg Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 120 μg/kg Q3W | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2: 120 μg/kg Q3W | 11 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 150 μg/kg Q3W | 12 | Not reported | Not reported | Not reported | Not reported |
| Part 2: 150 μg/kg Q3W | 25 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W and Q6W | 20 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 25
- group Id
- OG008
- value
- 20
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 26
- group Id
- OG006
- value
- 19
- group Id
- OG007
- value
- 68
- group Id
- OG008
- value
- 34
- units
- Participants
- description
- ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with ADCT-402, before the start of subsequent anticancer therapy or procedure. Tumor response was assessed using the 2014 Lugano Classification for response. CR is defined as achieving either of the following: * Complete metabolic response. * Complete radiologic response (target node regress to \<1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). PR is defined as achieving either of the following: * Partial metabolic response (findings indicate residual disease). * Partial remission (\>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by \>50% in length and no new lesions).
- groups
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG000
- title
- Part 1: 15 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG001
- title
- Part 1: 30 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG002
- title
- Part 1: 60 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG003
- title
- Part 1: 90 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG004
- title
- Part 1: 120 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG005
- title
- Part 2: 120 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG006
- title
- Part 1: 150 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG007
- title
- Part 2: 150 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
- id
- OG008
- title
- Part 1: 200 μg/kg Q3W and Q6W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- Baseline to End of Study (a maximum of 18 months)
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice