NCT01072175 · OUTCOME
Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)
What was measured
Hematology parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (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 Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.
Analysis population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| 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 | 94 |
|---|
Reported measurements
Hemoglobin (Increased)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemoglobin (Anemia)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 3 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 10 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | 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 | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes (Increased)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes (Decreased)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 8 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 8 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 24 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| 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 | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| 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 | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Total Neutrophils
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 1 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 3 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 3 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 10 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| 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 | 3 | 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 | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelet Count
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 2 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 2 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
White Blood Cell Count
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 0 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 2 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 4 |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 8 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| 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 | 4 | 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 |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Hemoglobin (Increased)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 10
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 10
- units
- Participants
- title
- Hemoglobin (Anemia)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Lymphocytes (Increased)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 19
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 24
- units
- Participants
- title
- Lymphocytes (Decreased)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 10
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 10
- units
- Participants
- title
- Total Neutrophils
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- units
- Participants
- title
- Platelet Count
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 8
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 8
- units
- Participants
- title
- White Blood Cell Count
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 94
- units
- Participants
- description
- Hematology parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (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 Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
- 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 Worst-case Hematology Toxicity Grade Change From Baseline
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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