TriangleNCT05185947 · OUTCOME
Percentage of Participants With a Clinicopathologic Response to Therapy by Response Evaluation Criteria in Solid Tumor (RECIST)v 1.1 Reported With a 95% Confidence Interval
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
- Participants were followed from baseline, every 9 weeks during treatment, and then every 3 months through study completion for 27 months, 14 days
What was measured
The percentage of participants with a clinicopathologic response will be reported for all participants along with a 95% confidence interval. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on available studies. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
Analysis population: 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment, for the duration of the study (27 months, 14 days).
Groups in this outcome
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
| Group | Source count |
|---|---|
| Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 4 |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 1 |
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | 1 |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | 1 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 100 | Not reported | 100.0 | 100.0 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 100 | Not reported | 100.0 | 100.0 | Not reported |
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | 100 | Not reported | 100.0 | 100.0 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | 100 | Not reported | 100.0 | 100.0 | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
| Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1 | 0.0 | Not reported | 0.0 | 0.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 100.0
- upper Limit
- 100.0
- value
- 100
- group Id
- OG001
- lower Limit
- 100.0
- upper Limit
- 100.0
- value
- 100
- group Id
- OG002
- lower Limit
- 100.0
- upper Limit
- 100.0
- value
- 100
- group Id
- OG003
- lower Limit
- 100.0
- upper Limit
- 100.0
- value
- 100
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 0.0
- value
- 0.0
- title
- Progressive Disease
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- The percentage of participants with a clinicopathologic response will be reported for all participants along with a 95% confidence interval. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on available studies. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
- id
- OG000
- title
- Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
- description
- Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
- id
- OG001
- title
- Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
- description
- Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
- id
- OG002
- title
- Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
- description
- Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
- id
- OG003
- title
- Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
- param Type
- NUMBER
- population Description
- 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment, for the duration of the study (27 months, 14 days).
- reporting Status
- POSTED
- time Frame
- Participants were followed from baseline, every 9 weeks during treatment, and then every 3 months through study completion for 27 months, 14 days
- title
- Percentage of Participants With a Clinicopathologic Response to Therapy by Response Evaluation Criteria in Solid Tumor (RECIST)v 1.1 Reported With a 95% Confidence Interval
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice