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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8353-014 | Other Identifier | Merck |
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This is a multicenter, worldwide, open-label study of MK-8353 in combination with selumetinib in participants with histologically or cytologically confirmed diagnosis of advanced solid tumor. This study will evaluate the safety, tolerability, and exploratory efficacy of MK-8353 in combination with selumetinib.
As specified by Phase 1 protocol-flexible language, modifications to the dose or dosing regimen can be made to achieve the scientific goals of the trial objectives and/or ensure appropriate safety of the trial participants. The proposed doses may be adjusted based on evaluation of safety, tolerability, and pharmacokinetic data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8353 and Selumetinib Dose Escalation | Experimental | Participants will receive a combination MK-8353 and selumetinib for 4 days on and 3 days off until disease progression or discontinuation. MK-8353 will be escalated sequentially from 50 mg to 250 mg based on pharmacokinetic and safety data. Selumetinib will be escalated sequentially from 25 mg to 75 mg based on pharmacokinetic and safety data. Doses may be adjusted downward sequentially based on tolerability |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8353 | Drug | Participants will receive MK-8353 orally twice daily (BID), escalated sequentially from 50 mg to 250 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Dose Limiting Toxicities | A dose limiting toxicity (DLT) is defined as any hematologic or non-hematologic toxicity ≥Grade 3 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The occurrence of any of the designated toxicities during Cycle 1 (3-week cycle) were considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study treatment administration. The number of participants experiencing DLTs was assessed. | Cycle 1 (3-week Cycle) (Up to 3 weeks) |
| Number of Participants Experiencing Adverse Events | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants experiencing AEs was assessed. | ~90 days after last treatment dose (up to ~45 weeks) |
| Number of Participants Discontinuing Study Treatment Due to AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants discontinuing study treatment due to AEs was assessed. | Up to ~33 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve for MK-8353 From Time 0 to 12 Hours | Blood samples were collected to determine the area under the curve from time 0 to 12 hours (AUC0-12). AUC is a measure of the amount of drug in the blood over time. | Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists ( Site 7000) | Sarasota | Florida | 34232 | United States | ||
| Next Oncology ( Site 0001) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37040046 | Result | Stathis A, Tolcher AW, Wang JS, Renouf DJ, Chen LC, Suttner LH, Freshwater T, Webber AL, Nayak T, Siu LL. Results of an open-label phase 1b study of the ERK inhibitor MK-8353 plus the MEK inhibitor selumetinib in patients with advanced or metastatic solid tumors. Invest New Drugs. 2023 Jun;41(3):380-390. doi: 10.1007/s10637-022-01326-3. Epub 2023 Apr 11. |
| Label | URL |
|---|---|
| Merck Oncology Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-8353 50 mg + Selumetinib 25 mg | Participants received 50 mg twice daily (BID) of MK-8353 and 25 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. |
| FG001 | MK-8353 100 mg + Selumetinib 50 mg | Participants received 100 mg BID of MK-8353 and 50 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. |
| FG002 | MK-8353 150 mg + Selumetinib 75 mg | Participants received 150 mg BID of MK-8353 and 75 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-8353 50 mg + Selumetinib 25 mg | Participants received 50 mg twice daily (BID) of MK-8353 and 25 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. |
| BG001 | MK-8353 100 mg + Selumetinib 50 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Experiencing Dose Limiting Toxicities | A dose limiting toxicity (DLT) is defined as any hematologic or non-hematologic toxicity ≥Grade 3 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The occurrence of any of the designated toxicities during Cycle 1 (3-week cycle) were considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study treatment administration. The number of participants experiencing DLTs was assessed. | The analysis population included all participants who received at least 1 dose of study treatment who met the criteria for DLT evaluability (finished Cycle 1 without a DLT or experienced a DLT in Cycle 1). | Posted | Count of Participants | Participants | Cycle 1 (3-week Cycle) (Up to 3 weeks) |
|
Non-serious adverse events (NSAEs): Up to ~45 weeks; Serious adverse events (SAEs): Up to ~45 weeks. All-cause mortality: Up to 24 months
NSAE, SAE, and all-cause mortality tables include all randomized participants who received at least 1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
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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 | MK-8353 50 mg + Selumetinib 25 mg | Participants received 50 mg twice daily (BID) of MK-8353 and 25 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2018 | Feb 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000632607 | MK-8353 |
| C517975 | AZD 6244 |
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Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies.
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| Selumetinib | Drug | Participants will receive selumetinib orally BID, escalated sequentially from 25 mg to 75 mg. |
|
|
| AUC0-12 for Selumetinib | Blood samples were collected to determine the AUC0-12. AUC is a measure of the amount of drug in the blood over time. | Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose |
| Minimum Observed Plasma Concentration for MK-8353 | Blood samples were collected to determine the minimum observed plasma concentration (Cmin) which is the minimum amount of drug in the plasma after the dose is given. In cases where Cmin values were below the limit of quantification (BLOQ), arithmetic mean (percent coefficient of variation [%CV]) was reported instead of geometric mean (percent geometric coefficient of variation [%GCV]), since geometric mean (%GCV) was not calculable. In cases where all Cmin values were BLOQ, mean was not calculable and indicated as "NA." | Study Days 1 and 4 of Cycles 1 and 2 (3-week cycles). For Cycle 1, pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose; and for Cycle 2 pre-dose, and at 1 and 4 hours post-dose |
| Cmin for Selumetinib | Blood samples were collected to determine the Cmin which is the minimum amount of drug in the plasma after the dose is given. In cases where Cmin values were BLOQ, arithmetic mean (%CV) was reported instead of geometric mean (%GCV), since geometric mean (%GCV) was not calculable. In cases where all Cmin values were BLOQ, mean was not calculable and indicated as "NA." | Study Days 1 and 4 of Cycles 1 and 2 (3-week cycles). For Cycle 1, pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose; and for Cycle 2 pre-dose, and at 1 and 4 hours post-dose |
| Maximum Observed Plasma Concentration for MK-8353 | Blood samples were collected to determine the maximum observed plasma concentration (Cmax) which is the measure of the maximum amount of drug in the plasma after the dose is given. | Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose |
| Cmax for Selumetinib | Blood samples were collected to determine the Cmax which is the measure of the maximum amount of drug in the plasma after the dose is given. | Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose |
| San Antonio |
| Texas |
| 78229 |
| United States |
| BC Cancer-Vancouver Center ( Site 0011) | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Princess Margaret Cancer Centre ( Site 0012) | Toronto | Ontario | M5G 2M9 | Canada |
| Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 0020) | Bellinzona | Canton Ticino | 6500 | Switzerland |
| Sponsor Decision |
|
| Withdrawal by Subject |
|
Participants received 100 mg BID of MK-8353 and 50 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. |
| BG002 | MK-8353 150 mg + Selumetinib 75 mg | Participants received 150 mg BID of MK-8353 and 75 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | MK-8353 100 mg + Selumetinib 50 mg | Participants received 100 mg BID of MK-8353 and 50 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. |
| OG002 | MK-8353 150 mg + Selumetinib 75 mg | Participants received 150 mg BID of MK-8353 and 75 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. |
|
|
| Primary | Number of Participants Experiencing Adverse Events | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants experiencing AEs was assessed. | The analysis population included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | ~90 days after last treatment dose (up to ~45 weeks) |
|
|
|
| Primary | Number of Participants Discontinuing Study Treatment Due to AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants discontinuing study treatment due to AEs was assessed. | The analysis population included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to ~33 weeks |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve for MK-8353 From Time 0 to 12 Hours | Blood samples were collected to determine the area under the curve from time 0 to 12 hours (AUC0-12). AUC is a measure of the amount of drug in the blood over time. | The analysis population included all participants who were compliant with the study procedures and had available MK-8353 AUC data from at least 1 treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μmol/liter | Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose |
|
|
|
| Secondary | AUC0-12 for Selumetinib | Blood samples were collected to determine the AUC0-12. AUC is a measure of the amount of drug in the blood over time. | The analysis population included all participants who were compliant with the study procedures and had available selumetinib AUC data from at least 1 treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μmol/liter | Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose |
|
|
|
| Secondary | Minimum Observed Plasma Concentration for MK-8353 | Blood samples were collected to determine the minimum observed plasma concentration (Cmin) which is the minimum amount of drug in the plasma after the dose is given. In cases where Cmin values were below the limit of quantification (BLOQ), arithmetic mean (percent coefficient of variation [%CV]) was reported instead of geometric mean (percent geometric coefficient of variation [%GCV]), since geometric mean (%GCV) was not calculable. In cases where all Cmin values were BLOQ, mean was not calculable and indicated as "NA." | The analysis population included all participants who were compliant with the study procedures and had available MK-8353 Cmin data from at least 1 treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | μmol/liter | Study Days 1 and 4 of Cycles 1 and 2 (3-week cycles). For Cycle 1, pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose; and for Cycle 2 pre-dose, and at 1 and 4 hours post-dose |
|
|
|
| Secondary | Cmin for Selumetinib | Blood samples were collected to determine the Cmin which is the minimum amount of drug in the plasma after the dose is given. In cases where Cmin values were BLOQ, arithmetic mean (%CV) was reported instead of geometric mean (%GCV), since geometric mean (%GCV) was not calculable. In cases where all Cmin values were BLOQ, mean was not calculable and indicated as "NA." | The analysis population included all participants who were compliant with the study procedures and had available selumetinib Cmin data from at least 1 treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | μmol/liter | Study Days 1 and 4 of Cycles 1 and 2 (3-week cycles). For Cycle 1, pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose; and for Cycle 2 pre-dose, and at 1 and 4 hours post-dose |
|
|
|
| Secondary | Maximum Observed Plasma Concentration for MK-8353 | Blood samples were collected to determine the maximum observed plasma concentration (Cmax) which is the measure of the maximum amount of drug in the plasma after the dose is given. | The analysis population included all participants who were compliant with the study procedures and had available MK-8353 Cmax data from at least 1 treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | μmol/liter | Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose |
|
|
|
| Secondary | Cmax for Selumetinib | Blood samples were collected to determine the Cmax which is the measure of the maximum amount of drug in the plasma after the dose is given. | The analysis population included all participants who were compliant with the study procedures and had available selumetinib Cmax data from at least 1 treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | μmol/liter | Study Days 1 and 4 of Cycle 1 (3-week cycle) at pre-dose and at 1, 2, 4, 6 hours, and between 8 and 12 hours post-dose |
|
|
|
| 3 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | MK-8353 100 mg + Selumetinib 50 mg | Participants received 100 mg BID of MK-8353 and 50 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. | 8 | 12 | 3 | 12 | 11 | 12 |
| EG002 | MK-8353 150 mg + Selumetinib 75 mg | Participants received 150 mg BID of MK-8353 and 75 mg selumetinib orally with 4 days on and 3 days off until disease progression or discontinuation. | 6 | 15 | 4 | 15 | 15 | 15 |
| Ascites | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| External ear inflammation | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Retinopathy | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lip pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rectal tenesmus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Stoma site infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Vulvitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Subclavian vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
| MK-8353, Cycle 1, Day 4 |
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| Selumetinib, Cycle 1, Day 4 |
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| MK-8353, Cycle 1 Day 4 |
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| MK-8353, Cycle 2 Day 1 |
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| MK-8353, Cycle 2 Day 4 |
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| Selumetinib, Cycle 1, Day 4 |
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| Selumetinib, Cycle 2, Day 1 |
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| Selumetinib, Cycle 2, Day 4 |
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| MK-8353, Cycle 1, Day 4 |
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| Selumetinib, Cycle 1, Day 4 |
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