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The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the BRAFV600E mutation, who are refractory to radioactive iodine (RAI) therapy and have experienced disease progression following one or two prior VEGFR-targeted treatments.
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of dabrafenib plus trametinib in adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC) that is positive for the BRAF V600E mutation, refractory to radioactive iodine (RAI), and has progressed following prior vascular endothelial growth factor receptor (VEGFR) targeted therapy.
After eligibility assessment, patients will be randomized in a 2:1 ratio to receive either dabrafenib plus trametinib or placebo. Patients will be stratified by the number of prior VEGFR targeted therapies (one versus two) and prior lenvatinib treatment (yes versus no).
The scientific objective guiding the primary estimand is based on progression-free survival (PFS) as per blinded independent review committee (BIRC) assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
This study will enroll approximately 150 patients.
Patients randomized to the placebo arm who experience disease progression as per RECIST 1.1 confirmed by BIRC and meet eligibility criteria will have the option to cross over to the open-label combination of dabrafenib plus trametinib.
Treatment may continue beyond RECIST 1.1 disease progression (confirmed by BIRC) if, in the investigator's judgment, there is evidence of clinical benefit and the patient wishes to remain on study treatment. In cases where there is a discrepancy between local site determination and BIRC (for example, disease progression determined locally but not by BIRC), the patient should not be discontinued from study treatment until progression is confirmed by BIRC or, at a minimum, until one additional tumor assessment has been completed, provided this is clinically acceptable.
After treatment discontinuation, all patients will be followed for safety and efficacy evaluations during the post-treatment follow-up period. Subsequently, patient status will be collected every 12 weeks as part of survival follow-up.
This study is ongoing, and enrollment was completed on 09-May-2024. The primary analysis was performed after all patients had either completed at least 16 weeks of treatment or discontinued early, and after approximately 95 PFS events had occurred.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabrafenib plus Trametinib | Experimental | Eligible participants will receive Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. |
|
| Dabrafenib Placebo plus Trametinib Placebo | Placebo Comparator | Eligible participants will receive matching placebo for Dabrafenib 150 mg twice a day (BID) and matching placebo for Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabrafenib | Drug | Dabrafenib 150 mg capsule administered orally twice a day (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression Free Survival (PFS) was defined as the time from the date of randomization to the date of the first documented progression according to RECIST 1.1 based on Blinded Independent Review Committee (BIRC) assessment, or death due to any cause. The primary analysis was conducted after all patients had either completed a minimum of 16 weeks of treatment or discontinued earlier, and following the occurrence of approximately 95 PFS events (Data cut-off date for the primary analysis was 22 January 2025). | From randomization to first documented progression or deaths, whichever comes first, assessed up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall Response Rate (ORR) was defined as the proportion of participants who had a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) according to RECIST 1.1. | From randomization assessed through Primary Analysis Cut-off date (approximately 3 years) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Med School | Chicago | Illinois | 60611 | United States | ||
| Massachusetts General Hospital |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Participants were randomized in a 2:1 ratio to either Dabrafenib plus Trametinib or placebo. Randomization was stratified by the number of prior VEGFR targeted therapies (1 vs. 2) and prior lenvatinib treatment (yes vs. no).
The study is conducted globally across 11 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabrafenib Plus Trametinib | Eligible participants will receive Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2023 | Jan 13, 2026 |
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Patients will be randomized in a 2:1 ratio to either dabrafenib plus trametinib or placebo. Patients will be stratified by number of prior VEGFR targeted therapy (1 versus 2) and prior Lenvatinib treatment (yes versus no).
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| Trametinib | Drug | Trametinib 2 mg tablet administered once a day (QD) |
|
|
| Trametinib Placebo | Drug | matching placebo tablet for Trametinib 2 mg will be administered orally once a day (QD) |
|
| Dabrafenib placebo | Drug | matching placebo capsule for Dabrafenib 150 mg will be administered orally twice a day (BID) |
|
| Overall Survival (OS) |
Overall Survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. |
| From randomization to death assessed up to approximately 5 years |
| Duration of Response (DOR) | Duration of Response (DOR) applied only to patients whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST 1.1. The start date was defined as the date of the first documented confirmed CR or PR, and the end date corresponded to the date of the first documented confirmed progression or death from any cause. Patients who remained without progression or death from any cause were censored at the date of their last adequate tumor assessment prior to the initiation of any new antineoplastic therapy. | From the first documented complete or partial response to the first documented progression or death, assessed up to Primary Analysis Cut-off date (approximately 3 years) |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | The distribution of adverse events will be conducted through the analysis of frequencies for treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs), based on the monitoring of relevant clinical and laboratory safety parameters. Treatment-emergent adverse events (TEAEs) in this study will be defined as events that begin after the first dose of study treatment and continue until 30 days after the last dose, or events that are present prior to the first dose and increase in severity based on preferred term within 30 days following the last dose. | Throughout study completion, an average 5 years |
| Number of Participants With Trametinib Associated Serous Retinopathy Ocular Events | Analysis of the optical coherence tomography data was performed to assess the incidence, type, and severity of trametinib-associated serous retinopathy ocular events, using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grading system: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to adverse event). | Up to approximately 3 years |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Novartis Investigative Site | CABA | Buenos Aires | C1417DTB | Argentina |
| Novartis Investigative Site | Rio de Janiero | Rio de Janeiro | 20231-050 | Brazil |
| Novartis Investigative Site | Blumenau | Santa Catarina | 89015-200 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01246-000 | Brazil |
| Novartis Investigative Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Novartis Investigative Site | London | Ontario | N6A 5W9 | Canada |
| Novartis Investigative Site | Fuzhou | Fujian | 350014 | China |
| Novartis Investigative Site | Zhengzhou | Henan | 450008 | China |
| Novartis Investigative Site | Wuhan | Hubei | 430022 | China |
| Novartis Investigative Site | Changsha | Hunan | 410013 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210006 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210009 | China |
| Novartis Investigative Site | Xuzhou | Jiangsu | 221003 | China |
| Novartis Investigative Site | Changchun | Jilin | 130033 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Tianjin | Tianjin Municipality | 300121 | China |
| Novartis Investigative Site | Beijing | 100036 | China |
| Novartis Investigative Site | Beijing | 100730 | China |
| Novartis Investigative Site | Guangzhou | 510060 | China |
| Novartis Investigative Site | Shanghai | 200233 | China |
| Novartis Investigative Site | Tianjin | 300052 | China |
| Novartis Investigative Site | Tianjin | 300480 | China |
| Novartis Investigative Site | Hisar | Haryana | 125005 | India |
| Novartis Investigative Site | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Novartis Investigative Site | Chennai | 600 020 | India |
| Novartis Investigative Site | George Town | Pulau Pinang | 10450 | Malaysia |
| Novartis Investigative Site | Kuching | Sarawak | 93586 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Seoul | 06591 | South Korea |
| Novartis Investigative Site | Tainan | 704302 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Istanbul | Fatih | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Edirne | Merkez | 22030 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | Yenimahalle | 06500 | Turkey (Türkiye) |
| Novartis Investigative Site | Adana | Yuregir | 01250 | Turkey (Türkiye) |
| Novartis Investigative Site | Hanoi | 100000 | Vietnam |
| FG001 | Dabrafenib Placebo Plus Trametinib Placebo | Eligible participants will receive matching placebos for Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression per RECIST 1.1 confirmed by a blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, loss to follow-up, death, or termination of the study by the sponsor. Participants randomized to the placebo arm who experience BIRC-confirmed disease progression per RECIST 1.1 and meet the eligibility criteria may cross over to receive open-label combination treatment with dabrafenib plus trametinib. |
|
| Ocular Event Evaluable Set | All participants from the safety set who had one baseline and at least two on-treatment optical coherence tomography (OCT) assessments. |
|
| Crossover Population Set | All participants who received at least one dose of any component of the open-label study treatment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabrafenib Plus Trametinib | Eligible participants will receive Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. |
| BG001 | Dabrafenib Placebo Plus Trametinib Placebo | Eligible participants will receive matching placebos for Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression per RECIST 1.1 confirmed by a blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, loss to follow-up, death, or termination of the study by the sponsor. Participants randomized to the placebo arm who experience BIRC-confirmed disease progression per RECIST 1.1 and meet the eligibility criteria may cross over to receive open-label combination treatment with dabrafenib plus trametinib. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Prior Vascular Endothelial Growth Factor (VEGFR) targeted therapies (1 vs. 2) | Count of Participants | Participants |
| ||||||||||||||||
| Prior lenvatinib treatment (yes vs no) | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Progression Free Survival (PFS) was defined as the time from the date of randomization to the date of the first documented progression according to RECIST 1.1 based on Blinded Independent Review Committee (BIRC) assessment, or death due to any cause. The primary analysis was conducted after all patients had either completed a minimum of 16 weeks of treatment or discontinued earlier, and following the occurrence of approximately 95 PFS events (Data cut-off date for the primary analysis was 22 January 2025). | Full Analysis Set (FAS). | Posted | Median | 95% Confidence Interval | Months | From randomization to first documented progression or deaths, whichever comes first, assessed up to approximately 3 years |
|
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| Secondary | Overall Response Rate (ORR) | Overall Response Rate (ORR) was defined as the proportion of participants who had a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) according to RECIST 1.1. | Full Analysis Set (FAS) | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization assessed through Primary Analysis Cut-off date (approximately 3 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. | Not Posted | Jun 2028 | From randomization to death assessed up to approximately 5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration of Response (DOR) applied only to patients whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST 1.1. The start date was defined as the date of the first documented confirmed CR or PR, and the end date corresponded to the date of the first documented confirmed progression or death from any cause. Patients who remained without progression or death from any cause were censored at the date of their last adequate tumor assessment prior to the initiation of any new antineoplastic therapy. | Full Analysis Set (FAS) - Only participants with first documented response (CR or PR) included. | Posted | Number | 95% Confidence Interval | Months | From the first documented complete or partial response to the first documented progression or death, assessed up to Primary Analysis Cut-off date (approximately 3 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | The distribution of adverse events will be conducted through the analysis of frequencies for treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs), based on the monitoring of relevant clinical and laboratory safety parameters. Treatment-emergent adverse events (TEAEs) in this study will be defined as events that begin after the first dose of study treatment and continue until 30 days after the last dose, or events that are present prior to the first dose and increase in severity based on preferred term within 30 days following the last dose. | Not Posted | Jun 2028 | Throughout study completion, an average 5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Trametinib Associated Serous Retinopathy Ocular Events | Analysis of the optical coherence tomography data was performed to assess the incidence, type, and severity of trametinib-associated serous retinopathy ocular events, using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grading system: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to adverse event). | Ocular Event Evaluable Set | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years |
|
The on-treatment period (up to 30 days after the last dose) and the post-treatment follow-up period are reported separately. Adverse Events (AEs) were reported during the on-treatment period and assessed up to the cut-off date for the primary analysis (22-Jan-2025), covering approximately 3 years. Deaths were monitored from the study start date through the cut-off date for the primary analysis (22-Jan-2025), also spanning approximately 3 years.
Deaths in the post-treatment follow-up were not considered Adverse Events (AEs). No AEs were collected in the post-treatment follow-up period. The total number at risk in the post-treatment follow-up included participants who entered this period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabrafenib Plus Trametinib (On-treatment) | Dabrafenib plus Trametinib - On-treatment Events up to the Primary Analysis Cut-off Date (January 22, 2025) | 17 | 101 | 43 | 101 | 96 | 101 |
| EG001 | Dabrafenib Placebo Plus Trametinib Placebo (On-treatment) | Dabrafenib Placebo plus Trametinib Placebo - On-treatment Events up to the Primary Analysis Cut-off Date (January 22, 2025) | 3 | 52 | 13 | 52 | 44 | 52 |
| EG002 | Crossover Dabrafenib Plus Trametinib (On-treatment) | Crossover Dabrafenib plus Trametinib - On-treatment Events for Placebo-Arm Participants with BIRC-Confirmed RECIST 1.1 Progression Who Transitioned to Open-Label Dabrafenib plus Trametinib at the Primary Analysis Cut-off (January 22, 2025) | 7 | 30 | 14 | 30 | 30 | 30 |
| EG003 | Dabrafenib Plus Trametinib (Post-treatment) | Dabrafenib plus Trametinib - Post-treatment Follow-up Events up to the Primary Analysis Cut-off Date (January 22, 2025) | 10 | 84 | 0 | 0 | 0 | 0 |
| EG004 | Dabrafenib Placebo Plus Trametinib Placebo (Post-treatment) | Dabrafenib Placebo plus Trametinib Placebo (including participants who crossed-over to open-label active treatment) - Post-treatment Follow-up Events up to the Primary Analysis Cut-off Date (January 22, 2025) | 16 | 49 | 0 | 0 | 0 | 0 |
| EG005 | Crossover Dabrafenib Plus Trametinib (Post-Treatment) | Crossover Dabrafenib plus Trametinib - Post-treatment Follow-up Events for Placebo-Arm Participants with BIRC-Confirmed RECIST 1.1 Progression Who Transitioned to Open-Label Dabrafenib plus Trametinib at the Primary Analysis Cut-off (January 22, 2025) | 6 | 23 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Detachment of retinal pigment epithelium | Eye disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (28.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (28.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Malignant pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Glycated serum protein increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Urinary occult blood positive | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Albuminuria | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2025 | Jan 13, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C561627 | dabrafenib |
| C560077 | trametinib |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 |
|
| No |
|
|
|
|
|
|
|
|