TriangleNCT02001623 · OUTCOME
Dose Escalation and Expansion Part: Progression Free Survival (PFS)
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
PFS was defined as the time in weeks from Day 1 in Cycle 1 to first disease progression or death, whichever occurred earliest, as assessed by the investigator. Only deaths that occurred within 60 days of the last visit were considered in the analysis and result are presented based on Kaplan-Meier estimates. Progression as defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase from nadir in the sum of diameters of target lesions, unequivocal progression in non-target lesions, or the appearance of new lesions
Analysis population: Participants with documented disease progression and/or death are included.
Groups in this outcome
Dose Escalation Part: 0.3 mg/kg
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
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
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 | 3 |
| Dose Escalation Part: 0.6 mg/kg | 3 |
| Dose Escalation Part: 0.9 mg/kg | 2 |
| Dose Escalation Part: 1.2 mg/kg | 2 |
| Dose Escalation Part: 1.5 mg/kg | 3 |
| Dose Escalation Part: 1.8 mg/kg | 2 |
| Dose Escalation Part: 2.0 mg/kg | 3 |
| Dose Escalation Part: 2.2 mg/kg | 3 |
| Dose Expansion Part: Bladder Cancer | 10 |
| Dose Expansion Part: Cervical Cancer | 41 |
| Dose Expansion Part: Endometrial Cancer | 4 |
| Dose Expansion Part: Esophageal Cancer | 10 |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 9 |
| Dose Expansion Part: Ovarian Cancer | 26 |
| Dose Expansion Part: Prostate Cancer | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 5.1 | Not reported | 4.9 | 5.4 | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 6.0 | Not reported | 3.9 | 49.1 | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 6.1 | Not reported | 4.9 | NA | Upper limit was not estimable because of insufficient number of participants with events prior to censoring. |
| Dose Escalation Part: 1.2 mg/kg | 27.1 | Not reported | 6.0 | NA | Upper limit was not estimable because of insufficient number of participants with events prior to censoring. |
| Dose Escalation Part: 1.5 mg/kg | 6.1 | Not reported | 5.3 | 10.4 | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 17.1 | Not reported | 11.3 | NA | Upper limit was not estimable because of insufficient number of participants with events prior to censoring |
| Dose Escalation Part: 2.0 mg/kg | 12.3 | Not reported | 5.0 | 14.1 | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 11.3 | Not reported | 2.1 | 11.3 | Not reported |
| Dose Expansion Part: Bladder Cancer | 11.0 | Not reported | 5.1 | 43.0 | Not reported |
| Dose Expansion Part: Cervical Cancer | 18.1 | Not reported | 9.3 | 23.0 | Not reported |
| Dose Expansion Part: Endometrial Cancer | NA | Not reported | 5.1 | NA | Median and upper limit were not estimable because of insufficient number of participants with events prior to censoring. |
| Dose Expansion Part: Esophageal Cancer | 10.1 | Not reported | 5.3 | 17.0 | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 13.0 | Not reported | 5.1 | 17.3 | Not reported |
| Dose Expansion Part: Ovarian Cancer | 13.0 | Not reported | 12.1 | 18.3 | Not reported |
| Dose Expansion Part: Prostate Cancer | 12.9 | Not reported | 7.1 | 23.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.9
- upper Limit
- 5.4
- value
- 5.1
- group Id
- OG001
- lower Limit
- 3.9
- upper Limit
- 49.1
- value
- 6.0
- comment
- Upper limit was not estimable because of insufficient number of participants with events prior to censoring.
- group Id
- OG002
- lower Limit
- 4.9
- upper Limit
- NA
- value
- 6.1
- comment
- Upper limit was not estimable because of insufficient number of participants with events prior to censoring.
- group Id
- OG003
- lower Limit
- 6.0
- upper Limit
- NA
- value
- 27.1
- group Id
- OG004
- lower Limit
- 5.3
- upper Limit
- 10.4
- value
- 6.1
- comment
- Upper limit was not estimable because of insufficient number of participants with events prior to censoring
- group Id
- OG005
- lower Limit
- 11.3
- upper Limit
- NA
- value
- 17.1
- group Id
- OG006
- lower Limit
- 5.0
- upper Limit
- 14.1
- value
- 12.3
- group Id
- OG007
- lower Limit
- 2.1
- upper Limit
- 11.3
- value
- 11.3
- group Id
- OG008
- lower Limit
- 5.1
- upper Limit
- 43.0
- value
- 11.0
- group Id
- OG009
- lower Limit
- 9.3
- upper Limit
- 23.0
- value
- 18.1
- comment
- Median and upper limit were not estimable because of insufficient number of participants with events prior to censoring.
- group Id
- OG010
- lower Limit
- 5.1
- upper Limit
- NA
- value
- NA
- group Id
- OG011
- lower Limit
- 5.3
- upper Limit
- 17.0
- value
- 10.1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 10
- group Id
- OG009
- value
- 41
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 10
- units
- Participants
- description
- PFS was defined as the time in weeks from Day 1 in Cycle 1 to first disease progression or death, whichever occurred earliest, as assessed by the investigator. Only deaths that occurred within 60 days of the last visit were considered in the analysis and result are presented based on Kaplan-Meier estimates. Progression as defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase from nadir in the sum of diameters of target lesions, unequivocal progression in non-target lesions, or the appearance of new lesions
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 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
- 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
- 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
- Participants with documented disease progression and/or death are included.
- reporting Status
- POSTED
- time Frame
- Day 1 to end of follow-up, up to a maximum of 60 weeks
- title
- Dose Escalation and Expansion Part: Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Weeks
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Preserved source evidence · Not medical advice