TriangleNCT02001623 · OUTCOME
Dose Expansion Part: 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
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 to end of follow-up, up to a maximum of 60 weeks
What was measured
DOR was defined as the median time in weeks from when confirmed response was first documented until the first documented disease progression, or death from any cause, whichever was earliest as assessed by the investigator. A responder was defined as any participant with a best overall response of confirmed CR or PR.
Analysis population: All participants who had a confirmed response of either CR or PR and were considered a responder for the study.
Groups in this outcome
Dose Escalation Part: 0.3 mg/kg
Dose Escalation Part: 0.3 mg/kgEdit Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
Dose Escalation Part: 0.6 mg/kg
Dose Escalation Part: 0.6 mg/kgEdit Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
Dose Escalation Part: 0.9 mg/kg
Dose Escalation Part: 0.9 mg/kgEdit Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
Dose Escalation Part: 1.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
Dose Escalation Part: 1.5 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
Dose Escalation Part: 1.8 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
Dose Escalation Part: 2.0 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Escalation Part: 2.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
Dose Expansion Part: Bladder Cancer
Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 |
| Dose Escalation Part: 0.6 mg/kg | 0 |
| Dose Escalation Part: 0.9 mg/kg | 0 |
| Dose Escalation Part: 1.2 mg/kg | 1 |
| Dose Escalation Part: 1.5 mg/kg | 0 |
| Dose Escalation Part: 1.8 mg/kg | 0 |
| Dose Escalation Part: 2.0 mg/kg | 0 |
| Dose Escalation Part: 2.2 mg/kg | 0 |
| Dose Expansion Part: Bladder Cancer | 4 |
| Dose Expansion Part: Cervical Cancer | 13 |
| Dose Expansion Part: Endometrial Cancer | 1 |
| Dose Expansion Part: Esophageal Cancer | 2 |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 2 |
| Dose Expansion Part: Ovarian Cancer | 5 |
| Dose Expansion Part: Prostate Cancer | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 1.2 mg/kg | NA | Not reported | NA | NA | Duration of response could not be estimated because DOR was censored for the single responder. |
| Dose Expansion Part: Bladder Cancer | 32.0 | Not reported | 11.0 | 32.0 | Not reported |
| Dose Expansion Part: Cervical Cancer | 18.4 | Not reported | 13.1 | 41.7 | Not reported |
| Dose Expansion Part: Endometrial Cancer | NA | Not reported | NA | NA | Duration of response could not be estimated because DOR was censored for the single responder. |
| Dose Expansion Part: Esophageal Cancer | 18.3 | Not reported | 11.6 | 25.0 | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | NA | Not reported | 12.0 | NA | Duration of response and the upper CI limit could not be estimated because DOR for one responder was censored later than the observed DOR for the other responder. |
| Dose Expansion Part: Ovarian Cancer | 21.4 | Not reported | 13.1 | 29.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Duration of response could not be estimated because DOR was censored for the single responder.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG008
- lower Limit
- 11.0
- upper Limit
- 32.0
- value
- 32.0
- group Id
- OG009
- lower Limit
- 13.1
- upper Limit
- 41.7
- value
- 18.4
- comment
- Duration of response could not be estimated because DOR was censored for the single responder.
- group Id
- OG010
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG011
- lower Limit
- 11.6
- upper Limit
- 25.0
- value
- 18.3
- comment
- Duration of response and the upper CI limit could not be estimated because DOR for one responder was censored later than the observed DOR for the other responder.
- group Id
- OG012
- lower Limit
- 12.0
- upper Limit
- NA
- value
- NA
- group Id
- OG013
- lower Limit
- 13.1
- upper Limit
- 29.6
- value
- 21.4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 13
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 2
- units
- Participants
- description
- DOR was defined as the median time in weeks from when confirmed response was first documented until the first documented disease progression, or death from any cause, whichever was earliest as assessed by the investigator. A responder was defined as any participant with a best overall response of confirmed CR or PR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Dose Escalation Part: 0.3 mg/kgEdit Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
- id
- OG000
- title
- Dose Escalation Part: 0.3 mg/kg
- description
- Dose Escalation Part: 0.6 mg/kgEdit Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
- id
- OG001
- title
- Dose Escalation Part: 0.6 mg/kg
- description
- Dose Escalation Part: 0.9 mg/kgEdit Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
- id
- OG002
- title
- Dose Escalation Part: 0.9 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
- id
- OG003
- title
- Dose Escalation Part: 1.2 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
- id
- OG004
- title
- Dose Escalation Part: 1.5 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
- id
- OG005
- title
- Dose Escalation Part: 1.8 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG006
- title
- Dose Escalation Part: 2.0 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
- id
- OG007
- title
- Dose Escalation Part: 2.2 mg/kg
- description
- Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG008
- title
- Dose Expansion Part: Bladder Cancer
- description
- Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG009
- title
- Dose Expansion Part: Cervical Cancer
- description
- Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG010
- title
- Dose Expansion Part: Endometrial Cancer
- description
- Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG011
- title
- Dose Expansion Part: Esophageal Cancer
- param Type
- MEDIAN
- population Description
- All participants who had a confirmed response of either CR or PR and were considered a responder for the study.
- reporting Status
- POSTED
- time Frame
- Day 1 to end of follow-up, up to a maximum of 60 weeks
- title
- Dose Expansion Part: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Weeks
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Preserved source evidence · Not medical advice