TriangleNCT01072175 · OUTCOME
Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)
What was measured
Blood pressure and heart rate were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Blood pressure measurement included systolic blood pressure (SBP, millimeters of mercury \[mmHg\]) and diastolic BP (DBP). Heart rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to \<60 bpm, change to normal or no change, or increase to \>100 bpm are presented.
Analysis population: ATP Population
Groups in this outcome
Part B: Dabrafenib 75 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
| Group | Source count |
|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 6 |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 23 |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 27 |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 78 |
Reported measurements
Heart rate, Decrease to <60 bpm
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 15 | Not reported | Not reported | Not reported | Not reported |
Heart rate, Change to normal or no change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 14 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 15 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 37 | Not reported | Not reported | Not reported | Not reported |
Heart rate, Increase to >100 bpm
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 26 | Not reported | Not reported | Not reported | Not reported |
SBP, Increase to G3 or G4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 8 | Not reported | Not reported | Not reported | Not reported |
DBP, Increase to G3 or G4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 15
- title
- Heart rate, Decrease to <60 bpm
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 37
- title
- Heart rate, Change to normal or no change
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 26
- title
- Heart rate, Increase to >100 bpm
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 8
- title
- SBP, Increase to G3 or G4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- title
- DBP, Increase to G3 or G4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 78
- units
- Participants
- description
- Blood pressure and heart rate were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Blood pressure measurement included systolic blood pressure (SBP, millimeters of mercury \[mmHg\]) and diastolic BP (DBP). Heart rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to \<60 bpm, change to normal or no change, or increase to \>100 bpm are presented.
- groups
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
- id
- OG000
- title
- Part B: Dabrafenib 75 mg + Trametinib 1 mg
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
- id
- OG001
- title
- Part B: Dabrafenib 150 mg + Trametinib 1 mg
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
- id
- OG002
- title
- Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
- description
- Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
- id
- OG003
- title
- Part B: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- NUMBER
- population Description
- ATP Population
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)
- title
- Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice