TriangleNCT02669017 · OUTCOME
Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to End of Study (a maximum of 18 months)
What was measured
DoR is defined among responders (complete response \[CR\] and partial response \[PR\]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response. Disease progression is defined as progressive metabolic disease or one of the follow: * Target node progression. * An individual extranodal lesion must be abnormal with length \>1.5cm and/or increase of length \>50%. * New or clear progression of nonmeasured lesions. * Regrowth of previously resolved lesions or new nodes \>1.5 cm in length. * New or recurrent bone marrow involvement. DoR is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
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. Results are pooled for all arms as specified in the protocol.
Groups in this outcome
Parts 1 and 2: ADCT-402
In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed: * Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W) * Dose Level 2: 30 μg/kg Day 1 Q3W * Dose Level 3: 60 μg/kg Day 1 Q3W * Dose Level 4: 90 μg/kg Day 1 Q3W * Dose Level 5: 120 μg/kg Day 1 Q3W * Dose Level 6: 150 μg/kg Day 1 Q3W * Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W). In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
| Group | Source count |
|---|---|
| Parts 1 and 2: ADCT-402 | 180 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Parts 1 and 2: ADCT-402 | 5.36 | Not reported | 4.04 | NA | Upper limit of the confidence interval was not reached. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of the confidence interval was not reached.
- group Id
- OG000
- lower Limit
- 4.04
- upper Limit
- NA
- value
- 5.36
- denoms
- counts
- group Id
- OG000
- value
- 180
- units
- Participants
- description
- DoR is defined among responders (complete response \[CR\] and partial response \[PR\]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response. Disease progression is defined as progressive metabolic disease or one of the follow: * Target node progression. * An individual extranodal lesion must be abnormal with length \>1.5cm and/or increase of length \>50%. * New or clear progression of nonmeasured lesions. * Regrowth of previously resolved lesions or new nodes \>1.5 cm in length. * New or recurrent bone marrow involvement. DoR is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed: * Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W) * Dose Level 2: 30 μg/kg Day 1 Q3W * Dose Level 3: 60 μg/kg Day 1 Q3W * Dose Level 4: 90 μg/kg Day 1 Q3W * Dose Level 5: 120 μg/kg Day 1 Q3W * Dose Level 6: 150 μg/kg Day 1 Q3W * Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W). In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
- id
- OG000
- title
- Parts 1 and 2: ADCT-402
- param Type
- MEDIAN
- 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. Results are pooled for all arms as specified in the protocol.
- reporting Status
- POSTED
- time Frame
- Baseline to End of Study (a maximum of 18 months)
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice