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| ID | Type | Description | Link |
|---|---|---|---|
| C4211007 | Other Identifier | Alias Study Number |
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The purpose of this signal seeking study is to determine whether treatment with MEK162 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study
This is a phase II, open label study to determine the efficacy and safety of treatment with MEK162 in patients with a diagnosis of select solid tumors or hematological malignancies that have been pre-identified (prior to study consent) to have activations of the RAS/RAF/MEK pathway and whose disease has progressed on or after standard treatment.
Genomic profiling is becoming more accessible to patients and their physicians. This is a signal-seeking study to match patients with mutations in RAF, RAS, NF1 or MEK to the ATP-noncompetitive MEK 1/2 inhibitor, MEK162. Pre-identification of these mutations or activations in the pathway will be performed locally at a CLIA certified laboratory prior to screening for participation on the trial.
Once the patient has been identified, treating physicians who are qualified investigators may contact Novartis to consider enrollment in this study. For the purpose of this study, genomic profiling is not considered part of screening. Informed consent must be signed before any screening activities take place. Once eligibility (screening criteria met) has been confirmed by Novartis, the patient will initiate therapy with single agent MEK162. The patient may not receive any additional anti-cancer therapy during treatment with MEK162.
Patients will continue to receive study treatment until disease progression (assessed by RECIST 1.1 or appropriate hematologic response criteria), unacceptable toxicity, death or discontinuation from study treatment for any other reason (e.g., withdrawal of consent, start of a new anti-neoplastic therapy or at the discretion of the investigator), otherwise known as End of Treatment. All patients who discontinue from study treatment due to disease progression must have their progression clearly documented.
Disease assessment (per RECIST 1.1 or appropriate hematological response criteria) will be performed every 8 weeks (±4 days) after first dose of study drug (Day 1 of every odd cycle), until disease progression or end of treatment, whichever occurs first. The frequency of disease assessment may be reduced to every 12 weeks for patients who have at least 4 post-baseline disease assessments and are clinically stable (except AML and MM patients). Scans will be assessed locally by the investigator. After discontinuation of treatment, patients, regardless of reason for treatment discontinuation, will be followed for safety for 30 days after the last dose.
All patients will be followed for survival status every 3 months for 2 years after the last patient has enrolled in the study regardless of treatment discontinuation reason (except if consent is withdrawn or patient is lost to follow-up.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEK162 | Experimental | MEK162 will be dosed on a flat scale of 45 mg twice daily on a continuous dosing schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEK162 | Drug | MEK162 will be dosed on a flat scale of 45 mg twice daily on a continuous dosing schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate (CBR) for Solid Tumors at Week 16 as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | CBR: participants with complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks. As per RECIST 1.1, CR: disappearance of all target and non-target lesions, normalization of tumor marker level, pathological lymph nodes assigned as target or non-target lesions must have a reduction in short axis to less than (<) 10 millimeter (mm); PR: at least a 30 percent (%) decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters; PD: at least a 20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all target lesions recorded at or after baseline, sum was also an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of >=1 new target or non-target lesions. | Week 16 |
| CBR for Hematologic Tumors at Week 16: Multiple Myeloma | CBR: participants with stringent complete response(sCR), CR, very good partial response(VGPR), PR/SD for at least 16 weeks. For hematologic tumors (multiple myeloma), sCR: negative immunofixation on serum, urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow plus normal free light chain(FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry/immunofluorescence; CR: negative immunofixation on the serum, urine, disappearance of any soft tissue, plasmacytomas and <5% plasma cells in bone marrow; VGPR: serum,urine M-component detectable by immunofixation but not on electrophoresis or>=90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR: >50% reduction of serum M-protein and reduction in 24hr urinary M-protein by >90%/to <200 mg/24 hr; SD: not meeting criteria for CR, VGPR, PRor PD; PD: increase of >25% from lowest response value in serum M-component, urine M-component and bone marrow plasma cell percentage. | Week 16 |
| CBR for Hematologic Tumors at Week 16: Acute Myeloid Leukemia |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) as Per RECIST Version 1.1 | ORR: percentage of participants with a best overall response (BOR) of CR or PR as assessed per RECIST version 1.1. BOR: the best response recorded from the start of the treatment until disease progression (PD). CR: disappearance of all target and non-target lesions, normalization of tumor marker level, pathological lymph nodes assigned as target or non-target lesions must have a reduction in short axis to less than <10 mm; PR: at least a 30 % decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; PD: at least a 20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all target lesions recorded at or after baseline, sum was also an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of >=1 new target or non-target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama / Mitchell Cancer Institute Univ South Alabama | Mobile | Alabama | 36688 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30181415 | Derived | Burkart J, Owen D, Shah MH, Abdel-Misih SRZ, Roychowdhury S, Wesolowski R, Haraldsdottir S, Reeser JW, Samorodnitsky E, Smith A, Konda B. Targeting BRAF Mutations in High-Grade Neuroendocrine Carcinoma of the Colon. J Natl Compr Canc Netw. 2018 Sep;16(9):1035-1040. doi: 10.6004/jnccn.2018.7043. |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Participants diagnosed with select solid tumors or hematological malignancies pre-identified (prior to study consent) and had an activation of the v-raf murine sarcoma viral oncogene (RAF)/ RAS oncogene [rat sarcoma viral oncogene homologue] (RAS)/mitogen-activated erk kinase (MEK) pathway and whose disease had progressed on or after standard treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Binimetinib (MEK162) | Participants received an oral dose of 45 milligram (mg) of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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CBR: participants with complete remission (CR), CR with incomplete blood count recovery (CRi), partial remission (PR) and no resposne for at least 16 weeks. For hematologic tumors (acute myeloid leukemia); CR: as bone marrow- < 5% blasts, no blasts with auer rods, peripheral blood- neutrophils ≥1.0*10^9/L and/or platelets ≥100*10^9/L, ≤1% blasts, no evidence of extramedullary disease (such as CNS or soft tissue involvement), transfusion independent; CRi: all the CR criteria were involved but platelet and neutrophil transfusions were also allowed; PR: bone marrow- 50% or greater decrease (absolute range 5-25% blasts), < 5% of blasts contain auer rods, peripheral blood- neutrophils <1.0*10^9/L and/or platelets <100*10^9/L, no evidence of extramedullary disease; no response: in case a patient did not achieve CR, CRi, PR or relapse for an individual response assessment.
| Week 16 |
| From the start of the treatment until disease progression (maximum up to 19.4 months) |
| ORR for Hematologic Tumors: Multiple Myeloma | ORR: percentage of participants with sCR, CR, VGPR or PR. For hematologic tumors (multiple myeloma), sCR: negative immunofixation on the serum, urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; CR: CR: negative immunofixation on the serum, urine, disappearance of any soft tissue, plasmacytomas and <5% plasma cells in bone marrow; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis or greater than equal to >=90% reduction in serum M-component plus urine M-component <100 mg per 24hour (hr); PR: >50% reduction of serum M-protein and reduction in 24 hr urinary M-protein by >90% or to <200 mg/24 hr. | From the start of the treatment until disease progression (maximum up to 19.4 months) |
| ORR for Hematologic Tumors: Acute Myeloid Leukemia | ORR: participants with complete remission (CR), CR with incomplete blood count recovery (CRi), partial remission (PR) and no resposne for at least 16 weeks. For hematologic tumors (acute myeloid leukemia); CR: as bone marrow- < 5% blasts, no blasts with auer rods, peripheral blood- neutrophils ≥1.0*10^9/L and/or platelets ≥100*10^9/L, ≤1% blasts, no evidence of extramedullary disease (such as CNS or soft tissue involvement), transfusion independent; CRi: all the CR criteria were involved but platelet and neutrophil transfusions were also allowed; PR: bone marrow- 50% or greater decrease (absolute range 5-25% blasts), < 5% of blasts contain auer rods, peripheral blood- neutrophils <1.0*10^9/L and/or platelets <100*10^9/L, no evidence of extramedullary disease. | From the start of the treatment until disease progression (maximum up to 19.4 months) |
| Progression-free Survival (PFS) as Per RECIST Version 1.1 | PFS was defined as the time from the date of first dose to the date of first documented PD or relapse or death due to any cause. PD: at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of >=1 new target or non-target lesions was also considered progression. PFS data was censored at date of last adequate tumor assessment. | From the date of first dose to the date of the first documented PD, censored date or death (maximum up to 19.4 months) |
| Overall Survival (OS) | OS was defined as the time from the date of first dose to the date of death due to any cause. If a participant was not known to have died, survival time was censored at the date of last contact. | From the date of first dose to the date of death due to any cause (maximum up to 19.4 months) |
| Duration of Response (DOR) as Per RECIST Version 1.1 | DOR was defined as the time from the first documented response (CR or PR) to the date of first documented disease progression, relapse or death due to any cause. As per RECIST 1.1, CR: disappearance of all target and non-target lesions, normalization of tumor marker level, pathological lymph nodes assigned as target or non-target lesions must have a reduction in short axis to <10 mm; PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; PD: at least a 20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all target lesions recorded at or after baseline, sum was also an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of >=1 new target or non-target lesions. The DOR was determined only in participants whose best response was PR or greater. | From the first documented response (CR or PR) to the date of the first documented PD or death (maximum up to 19.4 months) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 | Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated. Treatment-emergent adverse events were defined as new or worsening events that were collected from first study treatment date to last treatment date +30 days. AEs of all grades were reported. | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
| Number of Participants With Vital Sign Abnormality of Greater Than or Equal to (>=) Grade 3 as Per CTCAE v4.03 | Vital signs included hypertension, hypotension and weight decreased were reported. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated. Participants with grade 3 or higher vital sign abnormality are reported. | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcF) in millisecond (msec): greater than equal to (>=) 450 to less than (<) 480, >=480 to <500, >=500, increase from baseline >=30, increase from baseline >=60; 2) QTc interval adjusted according to Fridericia formula (QTcB) (msec): >=450 to <480, >=480 to <500, >=500, increase from baseline >=30, increase from baseline >=60. 3) QT (msec): >=450 to <480, >=480 to <500, >=500, increase from baseline >=30, increase from baseline >=60. | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
| Number of Participants With Shift From Baseline in Clinical Laboratory - Hematology Parameters | Laboratory parameters included hematological and biochemistry parameters. Hematological parameters included neutrophils, platelets, prothrombin time, activated partial thromboplastin time, INR, fibrinogen. Number of participants with hematological abnormalities by grades (as per Common Terminology Criteria for Adverse Events (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Participants with a grade shift of 3 or more from baseline are reported in this outcome measure. | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
| Number of Participants With Shift From Baseline in Clinical Laboratory - Biochemistry Parameters | Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters included: creatinine, phosphorus, albumin, gamma-glutamyl transferase, aspartate transaminase, alanine aminotransferase, alkaline phosphatase, total bilirubin, uric acid, amylase, lipase, creatine kinase, total cholesterol and triglycerides. Number of participants with biochemistry test abnormalities by grades (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Participants with a grade shift of 3 or more from baseline are reported in this outcome measure. | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
| Number of Participants With Shift From Baseline in Cardiac Imaging | Number of Participants With Shift From Baseline in Cardiac Imaging were reported. | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
| Alaska Oncology and Hematology AOH (2) |
| Anchorage |
| Alaska |
| 99508 |
| United States |
| Arizona Oncology Associates AZ Oncology Assoc. | Phoenix | Arizona | United States |
| Arizona Oncology Associates HOPE Division | Phoenix | Arizona | United States |
| Arizona Oncology Associates PC- NAHOA | Sedona | Arizona | 86336 | United States |
| Highlands Oncology Group Highlands Oncology Group (22) | Fayetteville | Arkansas | 72703 | United States |
| PCR Oncology | Pismo Beach | California | 93449 | United States |
| University of California Davis Cancer Center UC Davis Cancer (3) | Sacramento | California | 95817 | United States |
| Rocky Mountain Cancer Centers USOR | Boulder | Colorado | 80304 | United States |
| Yale University School of Medicine Yale Cancer Center | New Haven | Connecticut | 06511 | United States |
| Whittingham Cancer Center Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO | Norwich | Connecticut | 06360 | United States |
| Hematology Oncology PC Stamford Hospital | Stamford | Connecticut | 06902 | United States |
| Florida Cancer Specialists Florida Cancer Specialists (31 | Fort Myers | Florida | 33901 | United States |
| Memorial Cancer Institute Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | United States |
| Mt. Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| Ocala Oncology Center Dept. of Ocala Oncology Center | Ocala | Florida | 34474 | United States |
| Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4 | Ocoee | Florida | United States |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | United States |
| Lurie Children's Hospital of Chicago Developmental Therapeutics | Chicago | Illinois | 60611 | United States |
| Oncology Specialists, SC Onc Specialists | Park Ridge | Illinois | 60068-0736 | United States |
| Illinois Cancer Care IL. Cancer Care | Peoria | Illinois | 61615-7828 | United States |
| Indiana University Indiana Univ. - Purdue Univ. | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Hospitals & Clinics Regulatory Contact 2 | Iowa City | Iowa | 52242 | United States |
| Maryland Oncology Hematology, P.A. Oncology Hematology | Rockville | Maryland | 20850 | United States |
| Cancer and Hematology Centers of West Michigan Dept. of Oncology | Grand Rapids | Michigan | 49546 | United States |
| Metro MN CCOP - Coon Rapids | Coon Rapids | Minnesota | 55433 | United States |
| Research Medical Center Research Med Center (2) | Kansas City | Missouri | 64132 | United States |
| Washington University School of Medicine Washington University (16) | St Louis | Missouri | 63110 | United States |
| Glacier View Research Institute - Cancer Oncology Dept | Kalispell | Montana | 59901 | United States |
| Comprehensive Cancer Centers of Nevada CCC of Nevada (21) | Las Vegas | Nevada | 89109 | United States |
| Cancer Institute of New Jersey CINJ | New Brunswick | New Jersey | 08901 | United States |
| New Mexico Cancer Care Alliance Oncology Dept | Albuquerque | New Mexico | 87106 | United States |
| New York Oncology Hematology, P.C. NYOH Latham | Troy | New York | 12180 | United States |
| University of North Carolina Chapel Hill Physician Office Building | Chapel Hill | North Carolina | 27514 | United States |
| Duke University Medical Center Seeley G. Mudd Bldg. | Durham | North Carolina | 27710 | United States |
| Sanford Research/USD-Fargo Sanford Hematology Oncology | Fargo | North Dakota | 58122 | United States |
| Cleveland Clinic Foundation Cleveland Clinic (19) | Cleveland | Ohio | 44195 | United States |
| Ohio State University Medical Center Comprehensive Cancer Center | Columbus | Ohio | 43221 | United States |
| St. Charles Cancer Center | Bend | Oregon | 97701 | United States |
| Willamette Valley Clinical Studies Cancer Institute & Res. Ctr. | Eugene | Oregon | 97404 | United States |
| Northwest Cancer Specialists Vancouver Cancer Center | Portland | Oregon | 97210 | United States |
| Oregon Health & Science University Oregon Health & Science U (56) | Portland | Oregon | 97239 | United States |
| St. Luke's Hospital and Health Network St Luke's (2) | Bethlehem | Pennsylvania | United States |
| West Penn Allegheny Oncology Network | Natrona Heights | Pennsylvania | 15065 | United States |
| Abington Hematology Oncology Associates, Inc Abington Hem Onc Assoc (5) | Willow Grove | Pennsylvania | 19090 | United States |
| Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology | Chattanooga | Tennessee | 37404 | United States |
| The West Clinic Dept. of the West Clinic | Memphis | Tennessee | 38120 | United States |
| Sarah Cannon Research Institute Sarah Cannon Research Inst (51 | Nashville | Tennessee | 37203 | United States |
| Texas Oncology Presbyterian Hospital (3) | Dallas | Texas | 75246 | United States |
| Texas Oncology Texas Oncology - Denton | Dallas | Texas | 75246 | United States |
| Texas Oncology Austin Midtown | Dallas | Texas | 75251 | United States |
| Texas Oncology Texas Oncology - Midland | Dallas | Texas | 75251 | United States |
| Sammons Cancer Center - Texas Oncology Sammons Cancer Center (10) | Dallas | Texas | 78246 | United States |
| Oncology Consultants Oncology Group | Houston | Texas | 77024 | United States |
| MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3) | Houston | Texas | 77030 | United States |
| Cancer Care Centers of South Texas / HOAST CCC of So. TX-San Antonio (3) | San Antonio | Texas | 78229 | United States |
| Tyler Cancer Center Dept.ofTylerCancerCtr. (2) | Tyler | Texas | 75702 | United States |
| Deke Slayton Cancer Center Deke Slayton Cancer Center (2) | Webster | Texas | 77598 | United States |
| Intermountain Medical Center Intermountain Healthcare | Murray | Utah | 84157 | United States |
| Virginia Cancer Specialists, PC Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA | Reston | Virginia | 20190 | United States |
| Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc | Kennewick | Washington | 99336 | United States |
| Providence Regional Cancer System | Lacey | Washington | 98503 | United States |
| MultiCare Health System Institute for Research & Innovation MultiCare | Tacoma | Washington | 98405 | United States |
| Northwest Medical Specialties NW Medical Specialties | Tacoma | Washington | 98405 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Binimetinib (MEK162) | Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months. |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Clinical Benefit Rate (CBR) for Solid Tumors at Week 16 as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | CBR: participants with complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks. As per RECIST 1.1, CR: disappearance of all target and non-target lesions, normalization of tumor marker level, pathological lymph nodes assigned as target or non-target lesions must have a reduction in short axis to less than (<) 10 millimeter (mm); PR: at least a 30 percent (%) decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters; PD: at least a 20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all target lesions recorded at or after baseline, sum was also an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of >=1 new target or non-target lesions. | Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16 |
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| Primary | CBR for Hematologic Tumors at Week 16: Multiple Myeloma | CBR: participants with stringent complete response(sCR), CR, very good partial response(VGPR), PR/SD for at least 16 weeks. For hematologic tumors (multiple myeloma), sCR: negative immunofixation on serum, urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow plus normal free light chain(FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry/immunofluorescence; CR: negative immunofixation on the serum, urine, disappearance of any soft tissue, plasmacytomas and <5% plasma cells in bone marrow; VGPR: serum,urine M-component detectable by immunofixation but not on electrophoresis or>=90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR: >50% reduction of serum M-protein and reduction in 24hr urinary M-protein by >90%/to <200 mg/24 hr; SD: not meeting criteria for CR, VGPR, PRor PD; PD: increase of >25% from lowest response value in serum M-component, urine M-component and bone marrow plasma cell percentage. | Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16 |
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| Primary | CBR for Hematologic Tumors at Week 16: Acute Myeloid Leukemia | CBR: participants with complete remission (CR), CR with incomplete blood count recovery (CRi), partial remission (PR) and no resposne for at least 16 weeks. For hematologic tumors (acute myeloid leukemia); CR: as bone marrow- < 5% blasts, no blasts with auer rods, peripheral blood- neutrophils ≥1.0*10^9/L and/or platelets ≥100*10^9/L, ≤1% blasts, no evidence of extramedullary disease (such as CNS or soft tissue involvement), transfusion independent; CRi: all the CR criteria were involved but platelet and neutrophil transfusions were also allowed; PR: bone marrow- 50% or greater decrease (absolute range 5-25% blasts), < 5% of blasts contain auer rods, peripheral blood- neutrophils <1.0*10^9/L and/or platelets <100*10^9/L, no evidence of extramedullary disease; no response: in case a patient did not achieve CR, CRi, PR or relapse for an individual response assessment. | Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16 |
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| Secondary | Overall Response Rate (ORR) as Per RECIST Version 1.1 | ORR: percentage of participants with a best overall response (BOR) of CR or PR as assessed per RECIST version 1.1. BOR: the best response recorded from the start of the treatment until disease progression (PD). CR: disappearance of all target and non-target lesions, normalization of tumor marker level, pathological lymph nodes assigned as target or non-target lesions must have a reduction in short axis to less than <10 mm; PR: at least a 30 % decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; PD: at least a 20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all target lesions recorded at or after baseline, sum was also an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of >=1 new target or non-target lesions. | Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the start of the treatment until disease progression (maximum up to 19.4 months) |
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| Secondary | ORR for Hematologic Tumors: Multiple Myeloma | ORR: percentage of participants with sCR, CR, VGPR or PR. For hematologic tumors (multiple myeloma), sCR: negative immunofixation on the serum, urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; CR: CR: negative immunofixation on the serum, urine, disappearance of any soft tissue, plasmacytomas and <5% plasma cells in bone marrow; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis or greater than equal to >=90% reduction in serum M-component plus urine M-component <100 mg per 24hour (hr); PR: >50% reduction of serum M-protein and reduction in 24 hr urinary M-protein by >90% or to <200 mg/24 hr. | Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the start of the treatment until disease progression (maximum up to 19.4 months) |
| |||||||||||||||||||||||||||
| Secondary | ORR for Hematologic Tumors: Acute Myeloid Leukemia | ORR: participants with complete remission (CR), CR with incomplete blood count recovery (CRi), partial remission (PR) and no resposne for at least 16 weeks. For hematologic tumors (acute myeloid leukemia); CR: as bone marrow- < 5% blasts, no blasts with auer rods, peripheral blood- neutrophils ≥1.0*10^9/L and/or platelets ≥100*10^9/L, ≤1% blasts, no evidence of extramedullary disease (such as CNS or soft tissue involvement), transfusion independent; CRi: all the CR criteria were involved but platelet and neutrophil transfusions were also allowed; PR: bone marrow- 50% or greater decrease (absolute range 5-25% blasts), < 5% of blasts contain auer rods, peripheral blood- neutrophils <1.0*10^9/L and/or platelets <100*10^9/L, no evidence of extramedullary disease. | Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the start of the treatment until disease progression (maximum up to 19.4 months) |
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) as Per RECIST Version 1.1 | PFS was defined as the time from the date of first dose to the date of first documented PD or relapse or death due to any cause. PD: at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of >=1 new target or non-target lesions was also considered progression. PFS data was censored at date of last adequate tumor assessment. | Full analysis set included all the participants who had received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | From the date of first dose to the date of the first documented PD, censored date or death (maximum up to 19.4 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of first dose to the date of death due to any cause. If a participant was not known to have died, survival time was censored at the date of last contact. | Full analysis set included all the participants who had received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | From the date of first dose to the date of death due to any cause (maximum up to 19.4 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Per RECIST Version 1.1 | DOR was defined as the time from the first documented response (CR or PR) to the date of first documented disease progression, relapse or death due to any cause. As per RECIST 1.1, CR: disappearance of all target and non-target lesions, normalization of tumor marker level, pathological lymph nodes assigned as target or non-target lesions must have a reduction in short axis to <10 mm; PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; PD: at least a 20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all target lesions recorded at or after baseline, sum was also an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of >=1 new target or non-target lesions. The DOR was determined only in participants whose best response was PR or greater. | Full analysis set included all the participants who had received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From the first documented response (CR or PR) to the date of the first documented PD or death (maximum up to 19.4 months) |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 | Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated. Treatment-emergent adverse events were defined as new or worsening events that were collected from first study treatment date to last treatment date +30 days. AEs of all grades were reported. | Safety analysis set included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment. | Posted | Count of Participants | Participants | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Vital Sign Abnormality of Greater Than or Equal to (>=) Grade 3 as Per CTCAE v4.03 | Vital signs included hypertension, hypotension and weight decreased were reported. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated. Participants with grade 3 or higher vital sign abnormality are reported. | Safety analysis set included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment. | Posted | Count of Participants | Participants | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcF) in millisecond (msec): greater than equal to (>=) 450 to less than (<) 480, >=480 to <500, >=500, increase from baseline >=30, increase from baseline >=60; 2) QTc interval adjusted according to Fridericia formula (QTcB) (msec): >=450 to <480, >=480 to <500, >=500, increase from baseline >=30, increase from baseline >=60. 3) QT (msec): >=450 to <480, >=480 to <500, >=500, increase from baseline >=30, increase from baseline >=60. | Safety analysis set included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment. | Posted | Count of Participants | Participants | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Shift From Baseline in Clinical Laboratory - Hematology Parameters | Laboratory parameters included hematological and biochemistry parameters. Hematological parameters included neutrophils, platelets, prothrombin time, activated partial thromboplastin time, INR, fibrinogen. Number of participants with hematological abnormalities by grades (as per Common Terminology Criteria for Adverse Events (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Participants with a grade shift of 3 or more from baseline are reported in this outcome measure. | Safety analysis set included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Shift From Baseline in Clinical Laboratory - Biochemistry Parameters | Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters included: creatinine, phosphorus, albumin, gamma-glutamyl transferase, aspartate transaminase, alanine aminotransferase, alkaline phosphatase, total bilirubin, uric acid, amylase, lipase, creatine kinase, total cholesterol and triglycerides. Number of participants with biochemistry test abnormalities by grades (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Participants with a grade shift of 3 or more from baseline are reported in this outcome measure. | Safety analysis set included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Shift From Baseline in Cardiac Imaging | Number of Participants With Shift From Baseline in Cardiac Imaging were reported. | Safety analysis set included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment. | Posted | Count of Participants | Participants | From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months) |
|
|
From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment.
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 | Binimetinib (MEK162) | Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months. | 50 | 110 | 110 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dilatation ventricular | Cardiac disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v18.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Lymphorrhoea | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Chorioretinopathy | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| C548083 | Noonan Syndrome 5 |
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C581313 | binimetinib |
Not provided
Not provided
Not provided
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