NCT03345485 · OUTCOME
Area Under the Curve [AUC(0-t)] in Phase 2 and Sub Studies.
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Source last updated 2024-10-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng.h/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Blood samples were collected over a period of 24hr (phase 2 and sub-study 1) and 30hr (sub-study 2) on Cycle 1 Day 1 and Day 15.
Analysis population: All enrolled subjects in the Safety Population with at least 1 quantifiable pre-dose and 1 quantifiable post-dose PK plasma concentration in Cycle 1 were included in the PK Population. PK analyses were performed using the PK population. 48 subjects of the Safety Population were included in the PK Population.
Groups in this outcome
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
A dose of 60 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
A dose of 80 mg/m2 administered over 80 minutes on D1 and D15 of 4-week cycles.
Phase 2 All Cohorts
A dose of 80 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 6 |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 7 |
|---|
| Phase 2 All Cohorts | 35 |
|---|
Reported measurements
EDO-S101 concentration, Cycle 1 D1
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 6 |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 7 |
|---|
| Phase 2 All Cohorts | 35 |
|---|
Values in ng.h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 938 | 41.9 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 1680 | 22.6 | Not reported | Not reported | Not reported |
|---|
| Phase 2 All Cohorts | 1490 | 40.9 | Not reported | Not reported | Not reported |
|---|
EDO-S101 concentration, Cycle 1 D15
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 5 |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 6 |
|---|
| Phase 2 All Cohorts | 34 |
|---|
Values in ng.h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 943 | 53.7 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 1390 | 28.7 | Not reported | Not reported | Not reported |
|---|
| Phase 2 All Cohorts | 1520 | 41.7 | Not reported | Not reported | Not reported |
|---|
M2 metabolite concentration, Cycle 1 D1
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 5 |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 5 |
|---|
| Phase 2 All Cohorts | 24 |
|---|
Values in ng.h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 5.19 | 420 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 12.4 | 1430 | Not reported | Not reported | Not reported |
|---|
| Phase 2 All Cohorts | 0.865 | 248 | Not reported | Not reported | Not reported |
|---|
M2 metabolite concentration, Cycle 1 D15
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 3 |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 1 |
|---|
| Phase 2 All Cohorts | 24 |
|---|
Values in ng.h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 2.32 | 9060 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 48.6 | NA | Not reported | Not reported | Not calculated due to insufficient data |
|---|
| Phase 2 All Cohorts | 1.32 | 163 | Not reported | Not reported | Not reported |
|---|
M8 metabolite concentration, Cycle 1 D1
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 6 |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 7 |
|---|
| Phase 2 All Cohorts | 35 |
|---|
Values in ng.h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 36.0 | 80.5 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 54.4 | 61.2 | Not reported | Not reported | Not reported |
|---|
| Phase 2 All Cohorts | 47.7 | 48.3 | Not reported | Not reported | Not reported |
|---|
M8 metabolite concentration, Cycle 1 D15
Analysis denominator · Participants
| Group | Source count |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 5 |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 6 |
|---|
| Phase 2 All Cohorts | 34 |
|---|
Values in ng.h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tinostamustine (EDO-S101) - Sub Study 1 (SS1) | 40.9 | 94.1 | Not reported | Not reported | Not reported |
|---|
| Tinostamustine (EDO-S101) - Sub Study 2 (SS2) | 35.2 | 33.7 | Not reported | Not reported | Not reported |
|---|
| Phase 2 All Cohorts | 53.3 | 44.8 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 41.9
- value
- 938
- group Id
- OG001
- spread
- 22.6
- value
- 1680
- group Id
- OG002
- spread
- 40.9
- value
- 1490
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 35
- units
- Participants
- title
- EDO-S101 concentration, Cycle 1 D1
- categories
- measurements
- group Id
- OG000
- spread
- 53.7
- value
- 943
- group Id
- OG001
- spread
- 28.7
- value
- 1390
- group Id
- OG002
- spread
- 41.7
- value
- 1520
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 34
- units
- Participants
- title
- EDO-S101 concentration, Cycle 1 D15
- categories
- measurements
- group Id
- OG000
- spread
- 420
- value
- 5.19
- group Id
- OG001
- spread
- 1430
- value
- 12.4
- group Id
- OG002
- spread
- 248
- value
- 0.865
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- M2 metabolite concentration, Cycle 1 D1
- categories
- measurements
- group Id
- OG000
- spread
- 9060
- value
- 2.32
- comment
- Not calculated due to insufficient data
- group Id
- OG001
- spread
- NA
- value
- 48.6
- group Id
- OG002
- spread
- 163
- value
- 1.32
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- M2 metabolite concentration, Cycle 1 D15
- categories
- measurements
- group Id
- OG000
- spread
- 80.5
- value
- 36.0
- group Id
- OG001
- spread
- 61.2
- value
- 54.4
- group Id
- OG002
- spread
- 48.3
- value
- 47.7
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 35
- units
- Participants
- title
- M8 metabolite concentration, Cycle 1 D1
- categories
- measurements
- group Id
- OG000
- spread
- 94.1
- value
- 40.9
- group Id
- OG001
- spread
- 33.7
- value
- 35.2
- group Id
- OG002
- spread
- 44.8
- value
- 53.3
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 34
- units
- Participants
- title
- M8 metabolite concentration, Cycle 1 D15
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 35
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- A dose of 60 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles
- id
- OG000
- title
- Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
- description
- A dose of 80 mg/m2 administered over 80 minutes on D1 and D15 of 4-week cycles.
- id
- OG001
- title
- Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
- description
- A dose of 80 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles.
- id
- OG002
- title
- Phase 2 All Cohorts
- param Type
- GEOMETRIC_MEAN
- population Description
- All enrolled subjects in the Safety Population with at least 1 quantifiable pre-dose and 1 quantifiable post-dose PK plasma concentration in Cycle 1 were included in the PK Population. PK analyses were performed using the PK population. 48 subjects of the Safety Population were included in the PK Population.
- reporting Status
- POSTED
- time Frame
- Blood samples were collected over a period of 24hr (phase 2 and sub-study 1) and 30hr (sub-study 2) on Cycle 1 Day 1 and Day 15.
- title
- Area Under the Curve [AUC(0-t)] in Phase 2 and Sub Studies.
- type
- SECONDARY
- unit Of Measure
- ng.h/mL
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