TriangleNCT01524978 · OUTCOME
Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- milligrams (mg)
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 3 years
What was measured
Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m\^2) loading dose of cetuximab by infusion and then 200 mg/m\^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m\^2 loading dose of cetuximab and then 250 mg/m\^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m\^2 loading dose of cetuximab and then 250 mg/m\^2 weekly. Reported here are the maximum tolerated doses for each vemurafenib and cetuximab.
Analysis population: All participants from Cohort 3b who received at least one dose of study medication.
Groups in this outcome
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
Participants with NSCLC were treated with vemurafenib monotherapy.
Cohort 2: Ovarian Cancer - Vemurafenib
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Cohort 3a: Colorectal Cancer - Vemurafenib
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Cohort 4: Cholangiocarcinoma - Vemurafenib
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Cohort 6: Multiple Myeloma - Vemurafenib
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Cohort 7a: ECD/LCH - Vemurafenib
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
| Group | Source count |
|---|---|
| Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib | 0 |
| Cohort 2: Ovarian Cancer - Vemurafenib | 0 |
| Cohort 3a: Colorectal Cancer - Vemurafenib | 0 |
| Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 14 |
| Cohort 4: Cholangiocarcinoma - Vemurafenib | 0 |
| Cohort 6: Multiple Myeloma - Vemurafenib | 0 |
| Cohort 7a: ECD/LCH - Vemurafenib | 0 |
| Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | 0 |
| Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | 0 |
| Cohort 7d: Early Stage Astrocytoma - Vemurafenib | 0 |
| Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | 0 |
Reported measurements
vemurafenib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 960 | Not reported | Not reported | Not reported | Not reported |
cetuximab
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 400 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG003
- value
- 960
- title
- vemurafenib
- categories
- measurements
- group Id
- OG003
- value
- 400
- title
- cetuximab
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- units
- Participants
- description
- Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m\^2) loading dose of cetuximab by infusion and then 200 mg/m\^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m\^2 loading dose of cetuximab and then 250 mg/m\^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m\^2 loading dose of cetuximab and then 250 mg/m\^2 weekly. Reported here are the maximum tolerated doses for each vemurafenib and cetuximab.
- groups
- description
- Participants with NSCLC were treated with vemurafenib monotherapy.
- id
- OG000
- title
- Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
- description
- Participants with ovarian cancer were treated with vemurafenib monotherapy.
- id
- OG001
- title
- Cohort 2: Ovarian Cancer - Vemurafenib
- description
- Participants with colorectal cancer were treated with vemurafenib monotherapy.
- id
- OG002
- title
- Cohort 3a: Colorectal Cancer - Vemurafenib
- description
- Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
- id
- OG003
- title
- Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
- description
- Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
- id
- OG004
- title
- Cohort 4: Cholangiocarcinoma - Vemurafenib
- description
- Participants with multiple myeloma were treated with vemurafenib monotherapy.
- id
- OG005
- title
- Cohort 6: Multiple Myeloma - Vemurafenib
- description
- Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
- id
- OG006
- title
- Cohort 7a: ECD/LCH - Vemurafenib
- description
- Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
- id
- OG007
- title
- Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
- description
- Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
- id
- OG008
- title
- Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
- description
- Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
- id
- OG009
- title
- Cohort 7d: Early Stage Astrocytoma - Vemurafenib
- description
- Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
- id
- OG010
- title
- Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
- param Type
- NUMBER
- population Description
- All participants from Cohort 3b who received at least one dose of study medication.
- reporting Status
- POSTED
- time Frame
- Up to approximately 3 years
- title
- Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab
- type
- SECONDARY
- unit Of Measure
- milligrams (mg)
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Preserved source evidence · Not medical advice