Trial · NCT01524978
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
NCT01524978, Phase 2, Completed, Hoffmann-La Roche; results first posted 2017-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers. Trials, record NCT01524978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01524978
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
- NCT number
- NCT01524978
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 208 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Multiple Myeloma, Neoplasms
- Interventions
- cetuximab, vemurafenib, vemurafenib
- First posted
- 2012-02-02
- Last updated
- 2017-11-20
- Other registries' IDs
- eudract:2011-004426-10
- Results first posted
- 2017-11-20
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Best Overall Response Rate (BORR) | Up to approximately 3 years | Confirmed BORR: percentage of participants with an objective response (OR) (complete response \[CR\], partial response \[PR\], stringent CR \[sCR\] or very good PR \[VGPR\]) on 2 occasions \>/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: \>/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow; PR: \>/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \<200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour; sCR: CR plus normal free light chain (FLC) ratio and no clonal cells in bone marrow. |
| Secondary | Percentage of Participants With Confirmed Clinical Benefit | Up to approximately 3 years | Included were participants with confirmed PR or CR or Stable Disease (SD) that had lasted at least 6 months according to RECIST v1.1 or confirmed CR, PR, VGPR, sCR or SD for at least 6 months according to IMWG criteria. RECIST v1.1: PR: \>/= 30% decrease in the sum of diameters of target lesions; CR: disappearance of all target lesions; SD: not meeting criteria for CR, PR or progressive disease (PD). IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow; PR: \>/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \<200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow; SD: not meeting criteria for CR, VGPR, PR or PD. |
| Secondary | Overall Response Rate (ORR) | Up to approximately 3 years | ORR: percentage of participants with an objective response (OR) (CR, PR, sCR or VGPR) on 2 occasions \>/= 4 weeks apart as assessed by the Investigator using RECIST v1.1. or IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: \>/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow; PR: \>/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \<200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow. |
| Secondary | Duration of Response (DOR) | Up to approximately 3 years | DOR was defined as the period from the date of initial PR or CR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria, until the date of PD or death from any cause. RECIST v1.1: PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of \>/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas. |
| Secondary | Time to Response | Up to approximately 3 years | Time to response was defined as the time from the first day of study treatment to the date of first CR, or PR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of diameters of target lesions. IMWG criteria: CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow; PR: \>/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \< 200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow. |
| Secondary | Time to Tumor Progression (TTP) | Up to approximately 3 years | TTP was defined as time from the first day of study treatment to the first occurrence of progressive disease (PD). RECIST v1.1: PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of \>/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas. |
| Secondary | Progression Free Survival (PFS) | Up to approximately 3 years | PFS was defined as the time from the first day of study treatment, until the first documented PD or death from any cause, whichever occurs first. RECIST v1.1: PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG criteria: PD: increase of \>/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas. |
| Secondary | Overall Survival (OS) | Up to approximately 3 years | OS was defined as time between the first day of study treatment and date of death of any cause. |
| Secondary | Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab | Up to approximately 3 years | 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. |
| Secondary | Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab | Up to 28 days | 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 type and number of dose limited toxicities observed. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Best Overall Response Rate (BORR) | Up to approximately 3 years | ITT population included all participants enrolled in the study irrespective of whether they had received study drug or not. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Confirmed Clinical Benefit | Up to approximately 3 years | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Up to approximately 3 years | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to approximately 3 years | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | months | MEDIAN |
| SECONDARY | Time to Response | Up to approximately 3 years | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | months | MEDIAN |
| SECONDARY | Time to Tumor Progression (TTP) | Up to approximately 3 years | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Up to approximately 3 years | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 3 years | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | months | MEDIAN |
| SECONDARY | Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab | Up to approximately 3 years | All participants from Cohort 3b who received at least one dose of study medication. | milligrams (mg) | NUMBER |
| SECONDARY | Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab | Up to 28 days | All participants from Cohort 3b who received at least one dose of study medication. | dose-limiting toxicities | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group136
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Best Overall Response Rate (BORR) | Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib | 37.1 | 95% Confidence Interval 25.16 to 50.31 | percentage of participants | |
| Confirmed Best Overall Response Rate (BORR) | Cohort 2: Ovarian Cancer - Vemurafenib | 50.0 | 95% Confidence Interval 6.76 to 93.24 | percentage of participants | |
| Confirmed Best Overall Response Rate (BORR) | Cohort 3a: Colorectal Cancer - Vemurafenib | 0 | 95% Confidence Interval 0.00 to 30.85 | percentage of participants | |
| Confirmed Best Overall Response Rate (BORR) | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 7.4 | 95% Confidence Interval 0.91 to 24.29 | percentage of participants | |
| Confirmed Best Overall Response Rate (BORR) | Cohort 4: Cholangiocarcinoma - Vemurafenib | 22.2 | 95% Confidence Interval 2.81 to 60.01 | percentage of participants | |
| Confirmed Best Overall Response Rate (BORR) | Cohort 6: Multiple Myeloma - Vemurafenib | 22.2 | 95% Confidence Interval 2.81 to 60.01 | percentage of participants | |
| Confirmed Best Overall Response Rate (BORR) | Cohort 7a: ECD/LCH - Vemurafenib | 61.5 | 95% Confidence Interval 40.57 to 79.77 | percentage of participants | |
| Confirmed Best Overall Response Rate (BORR) | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | 25.0 | 95% Confidence Interval 5.49 to 57.19 | percentage of participants | |
| Confirmed Best Overall Response Rate (BORR) | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | 16.7 | 95% Confidence Interval 2.09 to 48.41 | percentage of participants | |
| Confirmed Best Overall Response Rate (BORR) | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | 33.3 | 95% Confidence Interval 7.49 to 70.07 | percentage of participants |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib | 62 | |
| Overall Study | STARTED | Cohort 2: Ovarian Cancer - Vemurafenib | 4 | |
| Overall Study | STARTED | Cohort 3a: Colorectal Cancer - Vemurafenib | 10 | |
| Overall Study | STARTED | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 27 | |
| Overall Study | STARTED | Cohort 4: Cholangiocarcinoma - Vemurafenib | 9 | |
| Overall Study | STARTED | Cohort 6: Multiple Myeloma - Vemurafenib | 9 | |
| Overall Study | STARTED | Cohort 7a: ECD/LCH - Vemurafenib | 26 | |
| Overall Study | STARTED | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | 12 | |
| Overall Study | STARTED | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | 12 | |
| Overall Study | STARTED | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | 9 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events360
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 3 | 27 | |
| other | Anaemia | Blood and lymphatic system disorders | Pooled Arm - Vemurafenib | 30 | 181 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 12 | 27 | |
| other | Abdominal pain | Gastrointestinal disorders | Pooled Arm - Vemurafenib | 12 | 181 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 4 | 27 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Pooled Arm - Vemurafenib | 0 | 181 | |
| other | Constipation | Gastrointestinal disorders | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 5 | 27 | |
| other | Constipation | Gastrointestinal disorders | Pooled Arm - Vemurafenib | 26 | 181 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 13 | 27 | |
| other | Diarrhoea | Gastrointestinal disorders | Pooled Arm - Vemurafenib | 49 | 181 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | ||
| Total, all-cause mortality | Pooled Arm - Vemurafenib | ||
| Total, other adverse events | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 26 | 27 |
| Total, other adverse events | Pooled Arm - Vemurafenib | 177 | 181 |
| Total, serious adverse events | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 11 | 27 |
| Total, serious adverse events | Pooled Arm - Vemurafenib | 91 | 181 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab vs Pooled Arm - Vemurafenib: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01524978
GET https://conductscience.org/api/trials/v1/NCT01524978/results?page=2