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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004426-10 | EudraCT Number |
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This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - vemurafenib | Experimental | Participants with NSCLC will be treated with vemurafenib monotherapy. |
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| Cohort 2: Ovarian Cancer - vemurafenib | Experimental | Participants with ovarian cancer will be treated with vemurafenib monotherapy. |
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| Cohort 3a: Colorectal Cancer - vemurafenib | Experimental | Participants with colorectal cancer will be treated with vemurafenib monotherapy. |
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| Cohort 3b: Colorectal Cancer - vemurafenib + cetuximab | Experimental | Participants with colorectal cancer will be treated with vemurafenib and cetuximab combination therapy. |
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| Cohort 4: Cholangiocarcinoma - vemurafenib | Experimental | Participants with cholangiocarcinoma will be treated with vemurafenib monotherapy. |
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| Cohort 6: Multiple Myeloma - vemurafenib |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Drug | Escalating doses administered on Day 1 and then once weekly by intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Best Overall Response Rate (BORR) | 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. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed Clinical Benefit | 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. |
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Inclusion Criteria:
For solid tumors only:
For multiple myeloma only:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology | Tucson | Arizona | 85704 | United States | ||
| Rocky Mountain Cancer Centers, LLP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37934000 | Derived | Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7. | |
| 30351999 | Derived | Kaley T, Touat M, Subbiah V, Hollebecque A, Rodon J, Lockhart AC, Keedy V, Bielle F, Hofheinz RD, Joly F, Blay JY, Chau I, Puzanov I, Raje NS, Wolf J, DeAngelis LM, Makrutzki M, Riehl T, Pitcher B, Baselga J, Hyman DM. BRAF Inhibition in BRAFV600-Mutant Gliomas: Results From the VE-BASKET Study. J Clin Oncol. 2018 Dec 10;36(35):3477-3484. doi: 10.1200/JCO.2018.78.9990. Epub 2018 Oct 23. |
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One participant with breast cancer was screened shortly after Cohort 5 (Breast Cancer) had been closed. This participant was allowed to enter the study in Cohort 7: Other BRAF V600-positive tumors. For analysis purposes Cohort 7 was split into sub-cohorts for indications with sufficient participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib | Participants with NSCLC were treated with vemurafenib monotherapy. |
| FG001 | Cohort 2: Ovarian Cancer - Vemurafenib | Participants with ovarian cancer were treated with vemurafenib monotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Experimental |
Participants with multiple myeloma will be treated with vemurafenib monotherapy. |
|
| Cohort 7: Other Solid Tumors - vemurafenib | Experimental | Participants with Erdheim-Chester disease (ECD), Langerhans cell histiocytosis (LCH), anaplastic thyroid cancer, advanced stage astrocytoma, early stage astrocytoma and other BRAF V600-positive tumors will be treated with vemurafenib monotherapy. Subcohorts will be analyzed separately if 7 or more participants are enrolled for each indication. |
|
| vemurafenib | Drug | Escalating doses given orally twice a day starting on Day 2 |
|
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| vemurafenib | Drug | 960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| Up to approximately 3 years |
| Overall Response Rate (ORR) | 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. | Up to approximately 3 years |
| Duration of Response (DOR) | 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. | Up to approximately 3 years |
| Time to Response | 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. | Up to approximately 3 years |
| Time to Tumor Progression (TTP) | 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. | Up to approximately 3 years |
| Progression Free Survival (PFS) | 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. | Up to approximately 3 years |
| Overall Survival (OS) | OS was defined as time between the first day of study treatment and date of death of any cause. | Up to approximately 3 years |
| Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab | 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. | Up to approximately 3 years |
| Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab | 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. | Up to 28 days |
| Safety: Percentage of Participants With Adverse Event | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Up to approximately 3 years |
| Aurora |
| Colorado |
| 80012 |
| United States |
| Massachusetts General Hospital;Oncology | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | United States |
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | 98902 | United States |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| Institut Bergonie; Oncologie | Bordeaux | 33076 | France |
| Centre Francois Baclesse; Oncologie | Caen | 14076 | France |
| Centre Georges François Leclerc | Dijon | 21000 | France |
| Centre Leon Berard; Departement Oncologie Medicale | Lyon | 69373 | France |
| Institut Paoli-Calmettes; Oncologie Medicale 1 | Marseille | 13273 | France |
| Centre Rene Gauducheau | Saint-Herblain | 44805 | France |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | 31059 | France |
| Institut Gustave Roussy; Sitep | Villejuif | 94805 | France |
| Klinik der Uni zu Koeln; Klinik I für Innere Medizin; Onkologie | Cologne | 50937 | Germany |
| Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung | Essen | 45122 | Germany |
| Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum | Mannheim | 68167 | Germany |
| Hospital Univ. Central de Asturias; Servicio de Oncologia | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28007 | Spain |
| Fundacion Jimenez Diaz; Servicio de Oncologia | Madrid | 28040 | Spain |
| Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Salamanca; Servicio de Oncologia | Salamanca | 37007 | Spain |
| Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | 46010 | Spain |
| Aberdeen Royal Infirmary | Aberdeen | AB25 2ZN | United Kingdom |
| The Royal Marsden Hospital; Dept of Medicine | London | SW3 5PT | United Kingdom |
| The Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| 26287849 | Derived | Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. N Engl J Med. 2015 Aug 20;373(8):726-36. doi: 10.1056/NEJMoa1502309. |
| FG002 | Cohort 3a: Colorectal Cancer - Vemurafenib | Participants with colorectal cancer were treated with vemurafenib monotherapy. |
| FG003 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| FG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| FG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| FG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| FG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| FG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| FG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| FG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all participants enrolled in the study irrespective of whether they had received study medication or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib | Participants with NSCLC were treated with vemurafenib monotherapy. |
| BG001 | Cohort 2: Ovarian Cancer - Vemurafenib | Participants with ovarian cancer were treated with vemurafenib monotherapy. |
| BG002 | Cohort 3a: Colorectal Cancer - Vemurafenib | Participants with colorectal cancer were treated with vemurafenib monotherapy. |
| BG003 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| BG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| BG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| BG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| BG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| BG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| BG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| BG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
| BG011 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
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| Primary | Confirmed Best Overall Response Rate (BORR) | 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. | ITT population included all participants enrolled in the study irrespective of whether they had received study drug or not. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
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| Secondary | Percentage of Participants With Confirmed Clinical Benefit | 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. | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
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| Secondary | Overall Response Rate (ORR) | 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. | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
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| Secondary | Duration of Response (DOR) | 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. | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
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| Secondary | Time to Response | 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. | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
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| Secondary | Time to Tumor Progression (TTP) | 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. | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
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| Secondary | Progression Free Survival (PFS) | 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. | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
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| Secondary | Overall Survival (OS) | OS was defined as time between the first day of study treatment and date of death of any cause. | ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
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| Secondary | Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab | 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. | All participants from Cohort 3b who received at least one dose of study medication. | Posted | Number | milligrams (mg) | Up to approximately 3 years |
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| Secondary | Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab | 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. | All participants from Cohort 3b who received at least one dose of study medication. | Posted | Number | dose-limiting toxicities | Up to 28 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety: Percentage of Participants With Adverse Event | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The safety population included all participants who received at least one dose of study medication. | Posted | Number | percentage of participants | Up to approximately 3 years |
|
From baseline up to approximately 3 years
The safety population included all participants who received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. | 11 | 27 | 26 | 27 | ||
| EG001 | Pooled Arm - Vemurafenib | Participants with a variety of cancer types, who were treated with vemurafenib monotherapy, were combined into this arm. | 91 | 181 | 177 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bladder dilatation | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Chronic myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Paraganglion neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Laryngeal dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dressler's syndrome | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pseudolymphoma | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Keratosis pilaris | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Milia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077484 | Vemurafenib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
Participants with ovarian cancer were treated with vemurafenib monotherapy.
| OG002 | Cohort 3a: Colorectal Cancer - Vemurafenib | Participants with colorectal cancer were treated with vemurafenib monotherapy. |
| OG003 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| OG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| OG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| OG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| OG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
|
|
| Cohort 3a: Colorectal Cancer - Vemurafenib |
Participants with colorectal cancer were treated with vemurafenib monotherapy. |
| OG003 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| OG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| OG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| OG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| OG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
|
|
| OG003 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| OG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| OG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| OG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| OG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
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| OG002 |
| Cohort 3a: Colorectal Cancer - Vemurafenib |
Participants with colorectal cancer were treated with vemurafenib monotherapy. |
| OG003 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| OG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| OG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| OG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| OG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
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| OG003 |
| Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab |
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| OG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| OG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| OG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| OG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
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| OG003 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| OG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| OG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| OG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| OG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
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| OG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| OG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| OG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| OG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
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Participants with colorectal cancer were treated with vemurafenib monotherapy. |
| OG003 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| OG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| OG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| OG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| OG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
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Participants with colorectal cancer were treated with vemurafenib monotherapy. |
| OG003 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| OG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| OG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| OG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| OG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
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| OG003 | Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. |
| OG004 | Cohort 4: Cholangiocarcinoma - Vemurafenib | Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. |
| OG005 | Cohort 6: Multiple Myeloma - Vemurafenib | Participants with multiple myeloma were treated with vemurafenib monotherapy. |
| OG006 | Cohort 7a: ECD/LCH - Vemurafenib | Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. |
| OG007 | Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. |
| OG008 | Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. |
| OG009 | Cohort 7d: Early Stage Astrocytoma - Vemurafenib | Participants with early stage astrocytoma were treated with vemurafenib monotherapy. |
| OG010 | Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. |
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