TriangleNCT02001623 · OUTCOME
Dose Escalation and Expansion Part: Objective Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 to end of follow-up, up to a maximum of 60 weeks
What was measured
Objective Response Rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Response assessment was investigator based for the escalation part and Independent Review Committee (IRC) based for the expansion part.
Analysis population: Full analysis set: all participants who had been exposed to tisotumab vedotin in either the dose escalation or expansion parts.
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 | 3 |
| Dose Escalation Part: 1.2 mg/kg | 3 |
| Dose Escalation Part: 1.5 mg/kg | 3 |
| Dose Escalation Part: 1.8 mg/kg | 3 |
| Dose Escalation Part: 2.0 mg/kg | 3 |
| Dose Escalation Part: 2.2 mg/kg | 6 |
| Dose Expansion Part: Bladder Cancer | 15 |
| Dose Expansion Part: Cervical Cancer | 55 |
| Dose Expansion Part: Endometrial Cancer | 14 |
| Dose Expansion Part: Esophageal Cancer | 15 |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 15 |
| Dose Expansion Part: Ovarian Cancer | 36 |
| Dose Expansion Part: Prostate Cancer | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 0 | Not reported | 0 | 46 | Not reported |
| Dose Expansion Part: Bladder Cancer | 27 | Not reported | 8 | 55 | Not reported |
| Dose Expansion Part: Cervical Cancer | 24 | Not reported | 13 | 37 | Not reported |
| Dose Expansion Part: Endometrial Cancer | 7 | Not reported | 0 | 34 | Not reported |
| Dose Expansion Part: Esophageal Cancer | 13 | Not reported | 2 | 40 | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 13 | Not reported | 2 | 40 | Not reported |
| Dose Expansion Part: Ovarian Cancer | 14 | Not reported | 5 | 29 | Not reported |
| Dose Expansion Part: Prostate Cancer | 0 | Not reported | 0 | 19 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG004
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG005
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG006
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG007
- lower Limit
- 0
- upper Limit
- 46
- value
- 0
- group Id
- OG008
- lower Limit
- 8
- upper Limit
- 55
- value
- 27
- group Id
- OG009
- lower Limit
- 13
- upper Limit
- 37
- value
- 24
- group Id
- OG010
- lower Limit
- 0
- upper Limit
- 34
- value
- 7
- group Id
- OG011
- lower Limit
- 2
- upper Limit
- 40
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 15
- group Id
- OG009
- value
- 55
- group Id
- OG010
- value
- 14
- group Id
- OG011
- value
- 15
- units
- Participants
- description
- Objective Response Rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Response assessment was investigator based for the escalation part and Independent Review Committee (IRC) based for the expansion part.
- 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
- NUMBER
- population Description
- Full analysis set: all participants who had been exposed to tisotumab vedotin in either the dose escalation or expansion parts.
- 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: Objective Response Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice