Not provided
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Lack of tolerability of BGB-3245 (Brimarafenib) when given in combination with Mirdametinib
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A Phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib in combination with BGB-3245 in adult participants with histologically confirmed, advanced (American Joint Committee on Cancer (AJCC) Stage III or IV) metastatic or unresectable solid cancer that is refractory to or has progressed during or after at least 1 line of appropriate prior systemic anti-cancer therapy including chemotherapy, immunotherapy, or appropriate targeted therapy, or for which there is no treatment available, or prior standard of care therapy was not tolerated.
The study will be conducted in two sequential parts: Part 1 dose escalation (Phase 1) and Part 2 dose expansion (Phase 2a).
Participants will receive mirdametinib and brimarafenib administered by mouth every day on a continuous schedule. Mirdametinib will be dosed twice a day (BID) and brimarafenib will be dosed once a day (QD). One treatment cycle will be 28 days.
Part 1 of the study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary evidence of anti-tumor efficacy. Part 1 will also identify the MTD and the RP2D for the combination of mirdametinib with brimarafenib.
Part 2 will confirm the safety, tolerability, efficacy, PK, and PDx for the combination of mirdametinib and brimarafenib. It will follow a parallel design and include one or more dose expansion cohorts, where each participant would be treated with the combination of mirdametinib and brimarafenib at the RP2D. It will begin after the RP2D for the combination of mirdametinib and brimarafenib is identified in Part 1. Part 2 may start either in parallel with, or after, the conduct and analysis of the PDx Expansion Cohort in Part 1.
Participants who experience a TEAE requiring treatment modification will be managed according to the applicable guidelines in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Escalation, Cohort 1 | Experimental | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway |
|
| Phase 1 Dose Escalation, Cohort 2 | Experimental | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway |
|
| Phase 1 Dose Escalation, Cohort 3 | Experimental | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway |
|
| Phase 1 Dose Escalation, Cohort 4 | Experimental | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway |
|
| Phase 1 Dose Escalation, Cohort 5 | Experimental | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirdametinib 2mg | Drug | Mirdametinib 2mg administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | Safety and tolerability endpoint evaluation via incidence of treatment emergent Adverse Events (TEAEs). TEAE severities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. AEs were coded using MedDRA Version 27.1. | All adverse events were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months). |
| Maximum Tolerated Dose (Part 1 Only) | The maximum tolerated dose (MTD) for mirdametinib and BGB-3245 administered as a combination, if any, will be based on safety and tolerability during the first 28 days of treatment in Cycle 1. | Up to 18 months |
| Recommended Phase 2 Dose [RP2D] (Part 1 Only) | The recommended phase 2 dose (RP2D) for mirdametinib and BGB-3245 administered as a combination will be determined based on safety, tolerability, PK, preliminary anti-tumor efficacy, and other available data. | Up to 24 months |
| Objective Response Rate (Part 2 Only) | Preliminary anti-tumor efficacy for the RP2D of mirdametinib and BGB-3245 administered as a combination as assessed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). Objective Response Rate (ORR) defined as the proportion of participants with complete response (CR) + partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (Part 1 Only) | Preliminary anti-tumor efficacy of mirdametinib and BGB-3245 administered as a combination as assessed by CT or MRI. ORR defined as the proportion of participants with Complete Response (CR) + Partial Response (PR) using RECIST v1.1. Responses were as reported by the investigators. | From participants' date of first dose of study treatment through end of treatment, an average of 3.5 months |
Not provided
Key Inclusion Criteria:
Able to provide informed consent
At least 18 years of age on day of signing ICF
Advanced, metastatic or unresectable solid cancer that has not responded to or progressed during or after at least 1 line of appropriate therapy or for which there is no treatment available or prior therapy was not tolerated.
Part 1: oncogenic mutation or other genomic aberration of the MAPK pathway
Part 2: oncogenic mutation or genomic aberration defined below:
Must have archival tumor tissue or agree to a fresh tumor biopsy at screening
Measurable disease per RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Adequate organ function and no transfusion within 14 days of first dose
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States | ||
| Yale-New Haven Hospital-Yale Cancer Center |
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Participants were enrolled in each Part 1 cohort following safety committee review. Study was terminated after Part 1 Cohort 5 was completed due to intolerance of the combination and no apparent early signs of efficacy. No participants were enrolled in Part 2 of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1, Cohort 1 - Dose Escalation | Mirdametinib: Mirdametinib 2mg bid administered orally BGB-3245: BGB-3245 5mg qd administered orally |
| FG001 | Phase 1, Cohort 2 - Dose Escalation | Mirdametinib: Mirdametinib 2mg bid administered orally BGB-3245: BGB-3245 10mg qd administered orally |
| FG002 | Phase 1, Cohort 3 - Dose Escalation | Mirdametinib: Mirdametinib 2mg bid administered orally BGB-3245: BGB-3245 20mg qd administered orally |
| FG003 | Phase 1, Cohort 4 - Dose Escalation | Mirdametinib: Mirdametinib 3mg bid administered orally BGB-3245: BGB-3245 10mg qd administered orally |
| FG004 | Phase 1, Cohort 5 - Dose Escalation | Mirdametinib: Mirdametinib 4mg bid administered orally BGB-3245: BGB-3245 10mg qd administered orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1, Cohort 1 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 2mg administered orally BGB-3245: BGB-3245 5mg administered orally |
| BG001 | Phase 1, Cohort 2 - Dose Escalation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Incidence of Treatment Emergent Adverse Events | Safety and tolerability endpoint evaluation via incidence of treatment emergent Adverse Events (TEAEs). TEAE severities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. AEs were coded using MedDRA Version 27.1. | Safety Population: All participants assigned to the study treatment and have taken at least one dose of study treatment (either Mirdametinib or BGB-3245). | Posted | Count of Participants | Participants | All adverse events were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months). |
|
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
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 | Phase 1, Cohort 1 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 2mg administered orally BGB-3245: BGB-3245 5mg administered orally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | SpringWorks Therapeutics | 8772794870 | clinical@springworkstx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2023 | May 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2024 | May 23, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C506614 | mirdametinib |
Not provided
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The study will be conducted in two sequential parts: Part 1 dose escalation (Phase 1) and Part 2 dose expansion (Phase 2a).
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|
| BGB-3245 5mg | Drug | BGB-3245 5mg administered orally |
|
|
| Mirdametinib 3mg | Drug | Mirdametinib 3mg administered orally |
|
|
| Mirdametinib 4mg | Drug | Mirdametinib 4mg administered orally |
|
|
| BGB-3245 10mg | Drug | BGB-3245 10mg administered orally |
|
|
| BGB-3245 20mg | Drug | BGB-3245 20mg administered orally |
|
|
| Duration of Response Rate | Duration of response rate in participants treated with the combination of mirdametinib and BGB-3245, defined as the time from response (CR + PR using RECIST v1.1) to disease progression and/or death. | Up to 36 months |
| Change in Plasma Concentrations of Mirdametinib and BGB-3245 | To determine the PK of mirdametinib and BGB-3245 administered as a combination in the eligible participant population. Plasma concentrations of mirdametinib and BGB-3245 will be measured to evaluate systemic exposures (AUC, Cmax, Ctrough, and other PK parameters as data allow). | Up to 24 months |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Calvary Mater Newcastle | Waratah | 2298 | Australia |
| Removal from Study |
|
| Withdrawal by Subject |
|
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 2mg administered orally BGB-3245: BGB-3245 10mg administered orally |
| BG002 | Phase 1, Cohort 3 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 2mg administered orally BGB-3245: BGB-3245 20mg administered orally |
| BG003 | Phase 1, Cohort 4 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 3mg administered orally BGB-3245: BGB-3245 10mg administered orally |
| BG004 | Phase 1, Cohort 5 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 4mg administered orally BGB-3245: BGB-3245 10mg administered orally |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Sex at Birth Reported | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of Cancer Diagnosis | Count of Participants | Participants |
|
| Time Since Initial Diagnosis | Some participants did not report initial diagnosis dates | Median | Inter-Quartile Range | months |
|
| Time Since First Metastatic Disease | Some participants did not report/did not have first metastatic disease dates. | Median | Inter-Quartile Range | months |
|
| Lesion Location | Participants may report more than one lesion location. | Count of Participants | Participants |
|
| Prior Anti-Cancer Therapy | Count of Participants | Participants |
|
| Prior Radiotherapy | Count of Participants | Participants |
|
| Number of Prior Lines of Cancer Therapy | Count of Participants | Participants |
|
| History of Prior Cancer Surgery - Indication | Count of Participants | Participants |
|
| History of Prior Cancer Surgery - Complete Resection | Count of Participants | Participants |
|
| Type of Mutation | Participants may report more than one type of mutation. | Count of Participants | Participants |
|
| OG001 | Phase 1, Cohort 2 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 2mg administered orally BGB-3245: BGB-3245 10mg administered orally |
| OG002 | Phase 1, Cohort 3 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 2mg administered orally BGB-3245: BGB-3245 20mg administered orally |
| OG003 | Phase 1, Cohort 4 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 3mg administered orally BGB-3245: BGB-3245 10mg administered orally |
| OG004 | Phase 1, Cohort 5 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 4mg administered orally BGB-3245: BGB-3245 10mg administered orally |
| OG005 | Phase 1 Overall - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib (of various doses) administered orally BGB-3245: BGB-3245 (of various doses) administered orally |
|
|
| Primary | Maximum Tolerated Dose (Part 1 Only) | The maximum tolerated dose (MTD) for mirdametinib and BGB-3245 administered as a combination, if any, will be based on safety and tolerability during the first 28 days of treatment in Cycle 1. | Safety Population: All participants assigned to the study treatment and have taken at least one dose of study treatment (either Mirdametinib or BGB-3245). | Posted | Number | mg | Up to 18 months |
|
|
|
| Primary | Recommended Phase 2 Dose [RP2D] (Part 1 Only) | The recommended phase 2 dose (RP2D) for mirdametinib and BGB-3245 administered as a combination will be determined based on safety, tolerability, PK, preliminary anti-tumor efficacy, and other available data. | Due to study termination during Phase 1 dose escalation a recommended phase 2 dose was not confirmed | Posted | Count of Participants | Participants | No | Up to 24 months |
|
|
|
| Primary | Objective Response Rate (Part 2 Only) | Preliminary anti-tumor efficacy for the RP2D of mirdametinib and BGB-3245 administered as a combination as assessed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). Objective Response Rate (ORR) defined as the proportion of participants with complete response (CR) + partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). | Due to study termination, no participants were enrolled in Phase 2 of the study | Posted | Up to 24 months |
|
|
| Secondary | Objective Response Rate (Part 1 Only) | Preliminary anti-tumor efficacy of mirdametinib and BGB-3245 administered as a combination as assessed by CT or MRI. ORR defined as the proportion of participants with Complete Response (CR) + Partial Response (PR) using RECIST v1.1. Responses were as reported by the investigators. | Efficacy Evaluable Population: All treated participants who have a baseline tumor response assessment (screening) and at least one post treatment tumor response assessment. | Posted | Count of Participants | Participants | From participants' date of first dose of study treatment through end of treatment, an average of 3.5 months |
|
|
|
| Secondary | Duration of Response Rate | Duration of response rate in participants treated with the combination of mirdametinib and BGB-3245, defined as the time from response (CR + PR using RECIST v1.1) to disease progression and/or death. | Duration of response could not be analyzed due to the objective response rate of 0% | Posted | Up to 36 months |
|
|
| Secondary | Change in Plasma Concentrations of Mirdametinib and BGB-3245 | To determine the PK of mirdametinib and BGB-3245 administered as a combination in the eligible participant population. Plasma concentrations of mirdametinib and BGB-3245 will be measured to evaluate systemic exposures (AUC, Cmax, Ctrough, and other PK parameters as data allow). | PK analysis as prespecified in the Statistical Analysis Plan, was not done and PK parameter data are not available due to the early termination of the study. Only concentration data is available. Not all participants in Cohort 5 completed Cycle 1 therefore samples were not collected. | Posted | Mean | Standard Deviation | ng/mL | Up to 24 months |
|
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Phase 1, Cohort 2 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 2mg administered orally BGB-3245: BGB-3245 10mg administered orally | 1 | 7 | 3 | 7 | 7 | 7 |
| EG002 | Phase 1, Cohort 3 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 2mg administered orally BGB-3245: BGB-3245 20mg administered orally | 0 | 6 | 5 | 6 | 5 | 6 |
| EG003 | Phase 1, Cohort 4 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 3mg administered orally BGB-3245: BGB-3245 10mg administered orally | 1 | 4 | 3 | 4 | 4 | 4 |
| EG004 | Phase 1, Cohort 5 - Dose Escalation | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib: Mirdametinib 4mg administered orally BGB-3245: BGB-3245 10mg administered orally | 1 | 3 | 3 | 3 | 3 | 3 |
| EG005 | Phase 1 Overall | Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway Mirdametinib and BGB-3245 of various dosing | 3 | 23 | 16 | 23 | 22 | 23 |
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 27.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| BGB-3245 Cycle 1 Day 1-1 hr |
|
|
| BGB-3245 Cycle 1 Day 1-2 hr |
|
|
| BGB-3245 Cycle 1 Day 1-4 hr |
|
|
| BGB-3245 Cycle 1 Day 22- Predose |
|
|
| BGB-3245 Cycle 2 Day 1 - Predose |
|
|
| BGB-3245 Cycle 2 Day 1 - 1 hr |
|
|
| BGB-3245 Cycle 2 Day 1 - 2 hr |
|
|
| BGB-3245 Cycle 2 Day 1 - 4 hr |
|
|
| BGB-3245 Cycle 3 Day 1 -Predose |
|
|
| Mirdametinib Cycle 1 Day 1- Predose |
|
|
| Mirdametinib Cycle 1 Day 1- 1 hr |
|
|
| Mirdametinib Cycle 1 Day 1- 2 hr |
|
|
| Mirdametinib Cycle 1 Day 1- 4 hr |
|
|
| Mirdametinib Cycle 1 Day 22- Predose |
|
|
| Mirdametinib Cycle 2 Day 1- Predose |
|
|
| Mirdametinib Cycle 2 Day 1- 1 hr |
|
|
| Mirdametinib Cycle 2 Day 1- 2 hr |
|
|
| Mirdametinib Cycle 2 Day 1- 4 hr |
|
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| Mirdametinib Cycle 3 Day 1- Predose |
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