TriangleNCT02001623 · OUTCOME
Dose Escalation and Expansion Part: Percentage Change From Baseline in CA-125
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Percentage Change
- Interval / dispersion
- Full Range
- Time frame
- Day 1 to end of follow-up, up to a maximum of 60 weeks
What was measured
In the dose escalation part, CA-125 was only assessed for participants with ovarian cancer. In the dose expansion part, CA-125 was intended to be assessed only for participants with ovarian and endometrium cancer, but was additionally assessed for some participants with NSCLC and cervical cancer.
Analysis population: Analyses includes all participants in the dose escalation and expansion parts with ovarian cancer and some participants with NSCLC and cervical cancer in the dose expansion part who have a baseline and end of study evaluable assessment.
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: 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 2.0mg/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: 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.
| 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 | 1 |
| Dose Escalation Part: 2.0 mg/kg | 1 |
| Dose Escalation Part: 2.2 mg/kg | 2 |
| Dose Expansion Part: Cervical Cancer | 8 |
| Dose Expansion Part: Endometrial Cancer | 10 |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 3 |
| Dose Expansion Part: Ovarian Cancer | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 1.2 mg/kg | 18.75 | Not reported | 18.75 | 18.75 | Not reported |
| Dose Escalation Part: 1.8 mg/kg | -13.98 | Not reported | -13.98 | -13.98 | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 113.71 | Not reported | 113.71 | 113.71 | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 11.62 | Not reported | -22.7 | 45.9 | Not reported |
| Dose Expansion Part: Cervical Cancer | -25.17 | Not reported | -88.7 | 240.5 | Not reported |
| Dose Expansion Part: Endometrial Cancer | 37.85 | Not reported | -46.1 | 666.2 | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 180.94 | Not reported | 47.1 | 980.5 | Not reported |
| Dose Expansion Part: Ovarian Cancer | 73.19 | Not reported | -89.0 | 1924.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG003
- lower Limit
- 18.75
- upper Limit
- 18.75
- value
- 18.75
- group Id
- OG005
- lower Limit
- -13.98
- upper Limit
- -13.98
- value
- -13.98
- group Id
- OG006
- lower Limit
- 113.71
- upper Limit
- 113.71
- value
- 113.71
- group Id
- OG007
- lower Limit
- -22.7
- upper Limit
- 45.9
- value
- 11.62
- group Id
- OG008
- lower Limit
- -88.7
- upper Limit
- 240.5
- value
- -25.17
- group Id
- OG009
- lower Limit
- -46.1
- upper Limit
- 666.2
- value
- 37.85
- group Id
- OG010
- lower Limit
- 47.1
- upper Limit
- 980.5
- value
- 180.94
- group Id
- OG011
- lower Limit
- -89.0
- upper Limit
- 1924.4
- value
- 73.19
- 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
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 25
- units
- Participants
- description
- In the dose escalation part, CA-125 was only assessed for participants with ovarian cancer. In the dose expansion part, CA-125 was intended to be assessed only for participants with ovarian and endometrium cancer, but was additionally assessed for some participants with NSCLC and cervical cancer.
- dispersion Type
- Full Range
- 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 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 2.0mg/kg of body weight.
- id
- OG008
- 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
- OG009
- title
- Dose Expansion Part: Endometrial Cancer
- description
- 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.
- id
- OG010
- title
- Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
- description
- 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.
- id
- OG011
- title
- Dose Expansion Part: Ovarian Cancer
- param Type
- MEDIAN
- population Description
- Analyses includes all participants in the dose escalation and expansion parts with ovarian cancer and some participants with NSCLC and cervical cancer in the dose expansion part who have a baseline and end of study evaluable assessment.
- 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: Percentage Change From Baseline in CA-125
- type
- SECONDARY
- unit Of Measure
- Percentage Change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice