TriangleNCT02001623 · OUTCOME
Dose Expansion Part: Anti-Tumor Activity Measured by Maximum Reduction Among Available Post-Baseline Sum of Lesion Measurements
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- millimeter(s)
- Interval / dispersion
- Full Range
- Time frame
- Day 1 to end of follow-up, up to a maximum of 60 weeks
What was measured
Anti-tumor activity measured by maximum reduction among available post-baseline sum of lesion measurements was not planned to be collected for the dose escalation part.
Analysis population: The number of participants analyzed includes all participants with baseline and one post-baseline evaluable tumor assessment
Groups in this outcome
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 Expansion Part: Bladder Cancer | 14 |
| Dose Expansion Part: Cervical Cancer | 50 |
| Dose Expansion Part: Endometrial Cancer | 12 |
| Dose Expansion Part: Esophageal Cancer | 11 |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 14 |
| Dose Expansion Part: Ovarian Cancer | 33 |
| Dose Expansion Part: Prostate Cancer | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Expansion Part: Bladder Cancer | 6.00 | Not reported | -127.0 | 41.0 | Not reported |
| Dose Expansion Part: Cervical Cancer | -8.50 | Not reported | -64.0 | 50.0 | Not reported |
| Dose Expansion Part: Endometrial Cancer | 1.00 | Not reported | -11.0 | 26.0 | Not reported |
| Dose Expansion Part: Esophageal Cancer | -2.00 | Not reported | -51.0 | 40.0 | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 0.00 | Not reported | -59.0 | 31.0 | Not reported |
| Dose Expansion Part: Ovarian Cancer | -4.00 | Not reported | -41.0 | 115.0 | Not reported |
| Dose Expansion Part: Prostate Cancer | -1.00 | Not reported | -11.0 | 15.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -127.0
- upper Limit
- 41.0
- value
- 6.00
- group Id
- OG001
- lower Limit
- -64.0
- upper Limit
- 50.0
- value
- -8.50
- group Id
- OG002
- lower Limit
- -11.0
- upper Limit
- 26.0
- value
- 1.00
- group Id
- OG003
- lower Limit
- -51.0
- upper Limit
- 40.0
- value
- -2.00
- group Id
- OG004
- lower Limit
- -59.0
- upper Limit
- 31.0
- value
- 0.00
- group Id
- OG005
- lower Limit
- -41.0
- upper Limit
- 115.0
- value
- -4.00
- group Id
- OG006
- lower Limit
- -11.0
- upper Limit
- 15.0
- value
- -1.00
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 14
- group Id
- OG005
- value
- 33
- group Id
- OG006
- value
- 12
- units
- Participants
- description
- Anti-tumor activity measured by maximum reduction among available post-baseline sum of lesion measurements was not planned to be collected for the dose escalation part.
- dispersion Type
- Full Range
- groups
- 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
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- title
- Dose Expansion Part: Esophageal 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
- OG004
- 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
- OG005
- title
- Dose Expansion Part: Ovarian Cancer
- description
- 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.
- id
- OG006
- title
- Dose Expansion Part: Prostate Cancer
- param Type
- MEDIAN
- population Description
- The number of participants analyzed includes all participants with baseline and one post-baseline evaluable tumor assessment
- reporting Status
- POSTED
- time Frame
- Day 1 to end of follow-up, up to a maximum of 60 weeks
- title
- Dose Expansion Part: Anti-Tumor Activity Measured by Maximum Reduction Among Available Post-Baseline Sum of Lesion Measurements
- type
- SECONDARY
- unit Of Measure
- millimeter(s)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice