TriangleNCT02711345 · OUTCOME
Changes From Baseline in Relative Quantity (RQ) of Dual Specificity Phosphatase 6 (DUSP6) in Tumor Tissue and in Blood
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Ratio
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Days 1, 2, 3, 15 and 16
What was measured
Assessment of Pharmacodynamic (PD) effects of LTT462 in tumor, pre- and post- treatment tumor biopsies were examined for expression of DUSP6. For assessment of PD effects in blood, levels of DUSP6 were measured in blood samples.
Analysis population: The full analysis set included all participants who had received at least one dose of LTT462.
Groups in this outcome
LTT462 45 mg QD
Participants received 45 mg LTT462 QD as oral capsules.
LTT462 100 mg QD
Participants received 100 mg LTT462 QD as oral capsules.
LTT462 150 mg QD
Participants received 150 mg LTT462 QD as oral capsules.
LTT462 200 mg QD
Participants received 200 mg LTT462 QD as oral capsules.
LTT462 300 mg QD
Participants received 300 mg LTT462 QD as oral capsules.
LTT462 400 mg QD
Participants received 400 mg LTT462 QD as oral capsules.
LTT462 450 mg QD
Participants received 450 mg LTT462 QD as oral capsules.
LTT462 600 mg QD
Participants received 600 mg LTT462 QD as oral capsules.
LTT462 150 mg BID
Participants received 150 mg LTT462 twice daily (BID) as oral capsules.
LTT462 200 mg BID
Participants received 200 mg LTT462 BID as oral capsules.
| Group | Source count |
|---|---|
| LTT462 45 mg QD | 2 |
| LTT462 100 mg QD | 3 |
| LTT462 150 mg QD | 6 |
| LTT462 200 mg QD | 4 |
| LTT462 300 mg QD | 8 |
| LTT462 400 mg QD | 6 |
| LTT462 450 mg QD | 12 |
| LTT462 600 mg QD | 6 |
| LTT462 150 mg BID | 6 |
| LTT462 200 mg BID | 12 |
Reported measurements
Tumor Sample
| Group | Source count |
|---|---|
| LTT462 45 mg QD | 1 |
| LTT462 100 mg QD | 2 |
| LTT462 150 mg QD | 4 |
| LTT462 200 mg QD | 1 |
| LTT462 300 mg QD | 4 |
| LTT462 400 mg QD | 1 |
| LTT462 450 mg QD | 4 |
| LTT462 600 mg QD | 1 |
| LTT462 150 mg BID | 2 |
| LTT462 200 mg BID | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LTT462 45 mg QD | -0.2 | NA | Not reported | Not reported | Standard deviation was not calculated due to single participant in the arm. |
| LTT462 100 mg QD | 0.8 | 1.11 | Not reported | Not reported | Not reported |
| LTT462 150 mg QD | -1.1 | 29.46 | Not reported | Not reported | Not reported |
| LTT462 200 mg QD | -28.8 | NA | Not reported | Not reported | Standard deviation was not calculated due to single participant in the arm. |
| LTT462 300 mg QD | -31.0 | 31.06 | Not reported | Not reported | Not reported |
| LTT462 400 mg QD | -56.5 | NA | Not reported | Not reported | Standard deviation was not calculated due to single participant in the arm. |
| LTT462 450 mg QD | -22.2 | 28.67 | Not reported | Not reported | Not reported |
| LTT462 600 mg QD | -79.9 | NA | Not reported | Not reported | Standard deviation was not calculated due to single participant in the arm. |
| LTT462 150 mg BID | -61.8 | 4.16 | Not reported | Not reported | Not reported |
| LTT462 200 mg BID | -14.4 | 22.27 | Not reported | Not reported | Not reported |
Blood Sample
| Group | Source count |
|---|---|
| LTT462 45 mg QD | 2 |
| LTT462 100 mg QD | 3 |
| LTT462 150 mg QD | 6 |
| LTT462 200 mg QD | 3 |
| LTT462 300 mg QD | 8 |
| LTT462 400 mg QD | 6 |
| LTT462 450 mg QD | 12 |
| LTT462 600 mg QD | 6 |
| LTT462 150 mg BID | 6 |
| LTT462 200 mg BID | 11 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LTT462 45 mg QD | -50.8 | 6.14 | Not reported | Not reported | Not reported |
| LTT462 100 mg QD | -66.1 | 40.22 | Not reported | Not reported | Not reported |
| LTT462 150 mg QD | -35.2 | 27.33 | Not reported | Not reported | Not reported |
| LTT462 200 mg QD | -34.7 | 22.02 | Not reported | Not reported | Not reported |
| LTT462 300 mg QD | -42.5 | 16.56 | Not reported | Not reported | Not reported |
| LTT462 400 mg QD | -43.0 | 13.67 | Not reported | Not reported | Not reported |
| LTT462 450 mg QD | -40.1 | 9.92 | Not reported | Not reported | Not reported |
| LTT462 600 mg QD | -40.4 | 21.04 | Not reported | Not reported | Not reported |
| LTT462 150 mg BID | -39.2 | 12.98 | Not reported | Not reported | Not reported |
| LTT462 200 mg BID | -32.9 | 18.71 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Standard deviation was not calculated due to single participant in the arm.
- group Id
- OG000
- spread
- NA
- value
- -0.2
- group Id
- OG001
- spread
- 1.11
- value
- 0.8
- group Id
- OG002
- spread
- 29.46
- value
- -1.1
- comment
- Standard deviation was not calculated due to single participant in the arm.
- group Id
- OG003
- spread
- NA
- value
- -28.8
- group Id
- OG004
- spread
- 31.06
- value
- -31.0
- comment
- Standard deviation was not calculated due to single participant in the arm.
- group Id
- OG005
- spread
- NA
- value
- -56.5
- group Id
- OG006
- spread
- 28.67
- value
- -22.2
- comment
- Standard deviation was not calculated due to single participant in the arm.
- group Id
- OG007
- spread
- NA
- value
- -79.9
- group Id
- OG008
- spread
- 4.16
- value
- -61.8
- group Id
- OG009
- spread
- 22.27
- value
- -14.4
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 3
- units
- Participants
- title
- Tumor Sample
- categories
- measurements
- group Id
- OG000
- spread
- 6.14
- value
- -50.8
- group Id
- OG001
- spread
- 40.22
- value
- -66.1
- group Id
- OG002
- spread
- 27.33
- value
- -35.2
- group Id
- OG003
- spread
- 22.02
- value
- -34.7
- group Id
- OG004
- spread
- 16.56
- value
- -42.5
- group Id
- OG005
- spread
- 13.67
- value
- -43.0
- group Id
- OG006
- spread
- 9.92
- value
- -40.1
- group Id
- OG007
- spread
- 21.04
- value
- -40.4
- group Id
- OG008
- spread
- 12.98
- value
- -39.2
- group Id
- OG009
- spread
- 18.71
- value
- -32.9
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 11
- units
- Participants
- title
- Blood Sample
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 12
- units
- Participants
- description
- Assessment of Pharmacodynamic (PD) effects of LTT462 in tumor, pre- and post- treatment tumor biopsies were examined for expression of DUSP6. For assessment of PD effects in blood, levels of DUSP6 were measured in blood samples.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received 45 mg LTT462 QD as oral capsules.
- id
- OG000
- title
- LTT462 45 mg QD
- description
- Participants received 100 mg LTT462 QD as oral capsules.
- id
- OG001
- title
- LTT462 100 mg QD
- description
- Participants received 150 mg LTT462 QD as oral capsules.
- id
- OG002
- title
- LTT462 150 mg QD
- description
- Participants received 200 mg LTT462 QD as oral capsules.
- id
- OG003
- title
- LTT462 200 mg QD
- description
- Participants received 300 mg LTT462 QD as oral capsules.
- id
- OG004
- title
- LTT462 300 mg QD
- description
- Participants received 400 mg LTT462 QD as oral capsules.
- id
- OG005
- title
- LTT462 400 mg QD
- description
- Participants received 450 mg LTT462 QD as oral capsules.
- id
- OG006
- title
- LTT462 450 mg QD
- description
- Participants received 600 mg LTT462 QD as oral capsules.
- id
- OG007
- title
- LTT462 600 mg QD
- description
- Participants received 150 mg LTT462 twice daily (BID) as oral capsules.
- id
- OG008
- title
- LTT462 150 mg BID
- description
- Participants received 200 mg LTT462 BID as oral capsules.
- id
- OG009
- title
- LTT462 200 mg BID
- param Type
- MEAN
- population Description
- The full analysis set included all participants who had received at least one dose of LTT462.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Days 1, 2, 3, 15 and 16
- title
- Changes From Baseline in Relative Quantity (RQ) of Dual Specificity Phosphatase 6 (DUSP6) in Tumor Tissue and in Blood
- type
- SECONDARY
- unit Of Measure
- Ratio
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice