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| ID | Type | Description | Link |
|---|---|---|---|
| C4211002 | Other Identifier | Alias Study Number | |
| 2012-003593-51 | EudraCT Number |
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Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEK162 | Experimental |
| |
| Dacarbazine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEK162 | Drug | MEK162 will be administered as a fixed dose of 45 mg (3 x 15 mg tablets) BID, with a glass of water and taken with or without food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | PFS: time from randomization to first documented PD or death due to any cause, whichever occurred first. RECIST 1.1, PD: >=20% increase in sum of diameter of target lesions (TLs) taking as reference the smallest sum on study (including baseline sum), sum must also be an absolute increase of >=5 mm; unequivocal progression of existing non-TLs; appearance of >=1 lesion. Complete response (CR): disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs. Partial response (PR): >=30% decrease in sum of diameter of all TLs, referring baseline sum of diameters. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor increase in lesions qualified for PD referring smallest sum diameter. With no event at time of analysis cut-off or at start of any new anti-neoplastic therapy, PFS censored at date of last adequate tumor assessment of CR, PR or SD. | From the date of randomization to the date of the first documented PD or death, whichever occurred first (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a participant was not known to have died, overall survival was censored at the date of last known date participant alive. | From the date of randomization to the date of death (maximum up to 107 weeks for binimetinib arm; maximum up to 88 weeks for dacarbazine arm) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Highlands Oncology Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28284557 | Derived | Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozon V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. doi: 10.1016/S1470-2045(17)30180-8. Epub 2017 Mar 9. |
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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 randomized were with previously untreated, advanced unresectable or metastatic Neuroblastoma RAS viral oncogene homolog (NRAS) mutation-positive melanoma as confirmed by central assessment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Binimetinib (MEK162) | Participants received oral binimetinib 45 milligram (mg) (3*15 mg tablets) twice daily, until disease progression (PD), unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of binimetinib treatment exposure in the study was 215.4 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per Blinded Independent Review Committee (BIRC), withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
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| Dacarbazine | Drug | Patients randomized to dacarbazine will receive an IV infusion of dacarbazine 1000 mg/m2 over the course of 1 hour on day 1 and then every three weeks. |
|
| Overall Response Rate (ORR) | ORR: percentage of participants with best overall response (BOR) of CR or PR. BOR: best response recorded from start of treatment until CR or PR. RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter of all TLs, taking as reference baseline sum of diameters. ORR is reported for confirmed and unconfirmed responses. Confirmed CR or PR = at least 2 determinations of CR or PR at least 4 weeks apart before PD. PD: >=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all TLs recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion. | From date of randomization until first documented response of CR or PR (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm) |
| Time to Response (TTR) | TTR: time between date of randomization until first documented response of CR or PR. RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter (dia) of all TLs, referring baseline sum of dia; c) PD: >=20% increase in sum of diameter of all measured TLs taking as reference smallest sum of diameter of all TLs recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-TLs. Appearance of >=1 new lesion. Participants who did not achieve PR or CR censored at last adequate tumor assessment date when they did not have PFS event (time from date of randomization to date of first documented PD or death due to any cause, whichever occur first) or at maximum follow-up when they had PFS event. | From date of randomization until first documented response of CR or PR (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm) |
| Duration of Objective Response (DOR) | DOR: time from date of first documented response (CR or PR) to first documented progression or death due to underlying cancer. RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter (dia) of all TLs, referring baseline sum of dia; c) PD: >=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 must also be absolute increase of >=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion. If a participant with a CR or PR had no PD or death due to underlying cancer, participants was censored at date of last adequate tumor assessment. | From the date of first documented response (CR or PR) to the first documented progression or death (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm) |
| Disease Control Rate (DCR) | DCR was calculated as the percentage of participants with a BOR of CR, PR, SD RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; c) SD: neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD taking as reference the smallest sum diameters; d) PD: >=20% increase in 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, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion. | From date of randomization until first documented response of CR, PR, SD or non-CR/non-PD (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm) |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs. | From baseline up to 219.4 weeks for binimetinib arm; From baseline up to 123.9 weeks for dacarbazine arm |
| Number of Participants With Clinically Notable Hematology Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.03 | Clinically notable shifts are defined as worsening by at least 2 grades or to >= grade 3. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
| Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on NCI-CTCAE Grade, Version 4.03 | Clinically notable shifts are defined as worsening by at least 2 grades or to >= grade 3. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
| Number of Participants With Clinically Notable Vital Signs | Abnormalities criteria included: low/high pulse rate (beats per minute [bpm]):<=50bpm with decrease from baseline >=15bpm/>=120bpm with increase from baseline >=15bpm; Low/high systolic blood pressure (millimeters of mercury [mmHg]): <=90mmHg with decrease from baseline >=20mmHg/>=160mmHg with increase from baseline >=20mmHg; Low/high diastolic blood pressure [mmHg]: <=50mmHg with decrease from baseline >=15mmHg/>=100mmHg with increase from baseline >=15mmHg; Low/high body weight (kilogram [kg]): >=20% decrease from baseline / >=10% increase from baseline; Low/high body temperature (degree Celsius [°C]): <=36°C / >= 37.5°C | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
| Number of Participants With Notable Electrocardiogram (ECG) Values | Criteria for notable ECG values were as follow: QT interval (in millisecond [msec]) new (newly occurring post-baseline value) greater than (>) 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Fredericia formula (QTcF) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Bazett's formula (QTcB) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; heart rate in bpm new (newly occurring post-baseline value) <60 and >100. | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
| Number of Participants With Adverse Events of Special Interest: Cardiac Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Here, in this outcome measure data is reported for events falling in any of the grades. | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
| Number of Participants With Clinically Significant Findings in Physical Examination | A complete physical examination included the examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lungs, heart, abdomen, back, lymph nodes, extremities, vascular and neurological systems. If indicated based on medical history and/or symptoms, rectal, external genitalia, breast, and pelvic examinations were performed. Clinical significance in physical examination was reported as adverse events. | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
| Number of Participants With Adverse Events of Special Interest: Ocular Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. Grade 1: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL; Grade 3: Severe or medically significant but not immediately sight threatening; Hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Sight-threatening consequences; urgent intervention indicated; blindness (20/200 or worse) in the affected eye. Here, in this outcome measure data is reported for events falling in any of the grades. | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
| Plasma Concentration of Binimetinib | Day 1 of Week 1: Pre-dose, 1, 1.5, 2, 10 hours post-dose; Day 1 of Weeks 4, 7: Pre-dose, 1.5 hours post-dose; Day 1 of Weeks 10, 13: Pre-dose |
| Time to Definitive 10% Deterioration in Global Health Status Score of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) | The time to definitive 10% deterioration was defined as the time from the date of randomization to the date of event, which was defined as death due to any cause or at least 10% worsening of the corresponding scale score, relative to baseline, with no later improvement above this threshold observed during the course of the study or death due to any cause. If a participant had no event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last adequate health related quality of life (HRQoL) evaluation. EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status scale, 3 symptom scales (nausea/vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range =0 to 100. High score for global health status = high quality of life. | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
| Change From Baseline in Global Health Status Score of EORTC QLQ-C30 at Weeks 4, 7, 13, 19, 25, 34, 43, 52, 61, 70, End of Treatment, Safety Follow-up Visit, Post-Treatment Follow-up Visit 1, 2, 3, 4, 5 and 6 | EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a h global health status scale, 3 symptom scales (nausea/vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range =0 to 100. High score for global health status = high quality of life. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy. | Both arms: Baseline, Day 1 Treatment Week (TW) 4,7,13,19,25,34,43,52; Post-treatment follow-up Visit (FUV) 1 to 6; Binimetinib: Day 1 TW61,70; End of treatment (EOT= TW73); Safety FUV=30 days post TW73; Dacarbazine: EOT=TW 57;Safety FUV=30 days post TW57 |
| Change From Baseline in EuroQoL-5 Dimensions- 5 Levels (EQ-5D-5L) Index Score at Weeks 4, 7, 13, 19, 25, 34, 43, 52, 61, 70, End of Treatment, Safety Follow-up Visit, Post-treatment Follow-up Visit 1, 2, 3, 4, 5 and 6 | EQ-5D-5L, is a standardized measure of health utility that provides a single index value for one's health status. EQ-5D-5L contained 1 item for each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Index score: participant responses to the 5 dimensions reflected a specific health state that corresponded to a population preference weight for that state on a continuous scale of 0 (death) to 1 (perfect health). Higher index scores = better health state. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy. | Both arms: Baseline, Day 1 Treatment Week (TW) 4,7,13,19,25,34,43,52; Post-treatment follow-up Visit (FUV) 1 to 6; Binimetinib: Day 1 TW61,70; End of treatment (EOT= TW73); Safety FUV=30 days post TW73; Dacarbazine: EOT=TW 57;Safety FUV=30 days post TW57 |
| Time to Definitive 1 Point Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | ECOG PS was used to assess the physical health of participants, and ranged from 0 (most active) to 5 (dead). ECOG PS grades: 0= fully active, able to carry on all pre-disease performance without restriction, 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4=completely disabled. cannot carry on any selfcare. Totally confined to bed or chair and 5= dead. Definitive deterioration is defined as on treatment death due to any cause or decrease in ECOG PS by at least one category from baseline score. | From baseline up to 73 weeks 3 days for binimetinib arm; From baseline up to 57 weeks 3 days for dacarbazine arm |
| Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | ECOG PS was used to assess the physical health of participants, and ranged from 0 (most active) to 5 (dead). ECOG PS grades: 0= fully active, able to carry on all pre-disease performance without restriction, 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4=completely disabled. cannot carry on any selfcare. Totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy. | For both arms: Baseline, Weeks 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55 and 30-day Follow-up For binimetinib only: Weeks 58, 61, 64, 67, 70, 73 |
| Number of Participants With Neuroblastoma RAS Viral (V-ras) Oncogene Homolog (NRAS) Mutation Status at Baseline | Number of participants with NRAS mutation status at baseline were reported. | Baseline |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Florida Cancer Specialists | Altamonte Springs | Florida | 32701 | United States |
| Florida Cancer Specialists | Bonita Springs | Florida | 34135 | United States |
| Florida Cancer Specialists | Bradenton | Florida | 34209 | United States |
| Florida Cancer Specialists | Brandon | Florida | 33511 | United States |
| Florida Cancer Specialists | Cape Coral | Florida | 33914 | United States |
| Florida Cancer Specialists | Clearwater | Florida | 33756 | United States |
| Florida Cancer Specialists | Clearwater | Florida | 33761 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33905 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33908 | United States |
| Florida Cancer Specialists | Gainesville | Florida | 32605 | United States |
| Florida Cancer Specialists | Hudson | Florida | 34667 | United States |
| Florida Cancer Specialists | Inverness | Florida | 34453 | United States |
| Florida Cancer Specialists | Largo | Florida | 33770 | United States |
| Florida Cancer Specialists | Largo | Florida | 33777 | United States |
| Florida Cancer Specialists | Naples | Florida | 34102 | United States |
| Florida Cancer Specialists | Naples | Florida | 34119 | United States |
| Florida Cancer Specialists | New Port Richey | Florida | 34655 | United States |
| Florida Cancer Specialists | Orange City | Florida | 32763 | United States |
| Florida Cancer Specialists | Orlando | Florida | 32806 | United States |
| Florida Cancer Specialists | Port Charlotte | Florida | 33980 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34236 | United States |
| Florida Cancer Specialists | Spring Hill | Florida | 34608 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33707 | United States |
| Florida Cancer Specialists | Tampa | Florida | 33607 | United States |
| Florida Cancer Specialists | Tampa | Florida | 33613 | United States |
| Florida Cancer Specialists | Tavares | Florida | 32778 | United States |
| Florida Cancer Specialists | Venice | Florida | 34285 | United States |
| Florida Cancer Specialists | Venice | Florida | 34292 | United States |
| Oncology Specialists, SC | Niles | Illinois | 60714 | United States |
| Oncology Specialists, SC | Park Ridge | Illinois | 60068 | United States |
| Goshen Center For Cancer Care | Goshen | Indiana | 46526 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Harry and Jeannette Weinberg Cancer Institute @Franklin Square | Baltimore | Maryland | 21237 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Kresge Eye Institute | Bingham Farms | Michigan | 48025 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Kresge Eye Institute | Detroit | Michigan | 48201 | United States |
| Karmanos Cancer Institute of Farmington Hills | Farmington Hills | Michigan | 48334 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Cooper University Hospital | Voorhees Township | New Jersey | 08043 | United States |
| The Ohio State University James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| The Ohio State University Martha Morehouse Medical Plaza | Columbus | Ohio | 43221 | United States |
| OHSU Knight Cancer Institute | Portland | Oregon | 97201 | United States |
| Kaiser Permanente Northwest Region Oncology/Hematology | Portland | Oregon | 97227 | United States |
| OHSU Center for Health and Healing | Portland | Oregon | 97239 | United States |
| OHSU | Portland | Oregon | 97239 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Cancer Center Associates - Medical Oncology | Allentown | Pennsylvania | 18104 | United States |
| St. Luke's Cancer Center - Allentown Campus | Allentown | Pennsylvania | 18104 | United States |
| St. Luke's Hospital - Allentown Campus | Allentown | Pennsylvania | 18104 | United States |
| Cancer Center Associates - Medical Oncology | Bethlehem | Pennsylvania | 18015 | United States |
| St. Luke's University Hospital - Bethlehem Campus | Bethlehem | Pennsylvania | 18015 | United States |
| St. Luke's Cancer Center - Anderson Campus | Easton | Pennsylvania | 18045 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson Medical Oncology | Philadelphia | Pennsylvania | 19107 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| St. Luke's Hospital - Quakertown Campus | Quakertown | Pennsylvania | 18951 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Texas Oncology-Austin Central | Austin | Texas | 78731 | United States |
| Elliot J. Ginchansky, MD, PA | Dallas | Texas | 75230 | United States |
| Dennis B. Kay | Dallas | Texas | 75231 | United States |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
| UT Southwestern University Hospital- St. Paul | Dallas | Texas | 75235 | United States |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | United States |
| UT Southwestern University Hospital - Zale Lipshy | Dallas | Texas | 75390 | United States |
| US Oncology | Fort Worth | Texas | 76177-3204 | United States |
| US Oncology | The Woodlands | Texas | 77380 | United States |
| Sanatorio de La Providencia | Buenos Aires | Ciudad Autónoma de Buenosaires | C1050AAK | Argentina |
| Centro de Investigación Clínica ? Clínica Viedma | Viedma | Río Negro Province | 08500 | Argentina |
| Centro Oncologico de Rosario | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Fundacion CIDEA | Buenos Aires | C1125ABE | Argentina |
| Chris O'Brien Lifehouse Hospital | Camperdown | New South Wales | 2050 | Australia |
| Lake Macquarie Private Hospital | Gateshead | New South Wales | 02290 | Australia |
| Melanoma Institute Australia | North Sydney | New South Wales | 2060 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 05000 | Australia |
| LKH-Universitätsklinikum Klinikum Graz | Graz | Styria | 08036 | Austria |
| Universitätsklinikum Innsbruck | Innsbruck | Tyrol | 06020 | Austria |
| Salzburger Landeskliniken | Salzburg | 05020 | Austria |
| Allgemeines Krankenhaus der Stadt Wien | Vienna | 01090 | Austria |
| Sint-Augustinuskliniek | Wilrijk | Antwerpen | 2610 | Belgium |
| UZ Gasthuisberg | Leuven | 03000 | Belgium |
| CHU Sart Tilman | Liège | 04000 | Belgium |
| Hospital de Clinicas de Passo Fundo | Passo Fundo | Rio Grande do Sul | 99010-260 | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90560-030 | Brazil |
| INCA Instituto Nacional de Cancer | Rio de Janeiro | 20220410 | Brazil |
| Hospital São José | São Paulo | 01321-001 | Brazil |
| Alberta Health Services - Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Sunnybrook Research Institute Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Center / Royal Victoria Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| CHU de Quebec - L'Hotel-Dieu de Quebec | Québec | G1R 2J6 | Canada |
| Mou/Mmci - Ppds | Brno | South Moravian | 656 53 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava | 708 52 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Vseobecna Fakultni Nemocnice V Praze | Prague | 128 08 | Czechia |
| CHU Angers | Angers | Maine-et-loire | 49033 | France |
| CHRU de Lille - Hôpital Huriet | Lille | NORD | 59037 | France |
| Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes | Lyon | Rhône | 69373 | France |
| Hôpital Saint-André | Bordeaux | 33000 | France |
| Centre Hospitalier Universitaire Ambroise Pare | Boulogne-Billancourt | 92100 | France |
| Centre Hospitalier Le Mans | Le Mans | 72037 | France |
| Hopitaux de La Timone | Marseille | 13385 | France |
| Groupe Hospitalier Archet I Et II | Nice | 06202 | France |
| Hôpital Saint Louis | Paris | 75010 | France |
| Service de PneumologieCHU Lyon Sud | Pierre-Bénite | 69495 | France |
| Hôpital Robert Debré | Reims | 51092 | France |
| Centre Hospitalier Universitaire Hopitaux de Rouen | Rouen | 76031 | France |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79104 | Germany |
| Klinikum Mannheim Universitätsklinikum gGmbH | Mannheim | Baden-Wurttemberg | 68135 | Germany |
| LMU Klinikum der Universität München | München | Bavaria | 80337 | Germany |
| University Clinic Regensburg - PPDS | Regensburg | Bavaria | 93053 | Germany |
| Universitätsklinikum Würzburg | Würzburg | Bavaria | 97080 | Germany |
| Institut für Diagnostische und Interventionelle Radiologie Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Elben Klinken Stade Buxtehude | Buxtehude | Lower Saxony | 21614 | Germany |
| Johannes Wesling Klinikum Minden | Minden | North Rhine-Westphalia | 32429 | Germany |
| Universitatsklinikum Leipzig | Leipzig | Saxony | 04103 | Germany |
| Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH | Quedlinburg | Saxony-Anhalt | 06484 | Germany |
| Charite Campus Mitte | Berlin | Schleswig-Holstein | 10117 | Germany |
| Helios Klinikum Erfurt | Erfurt | Thuringia | 99089 | Germany |
| Uniklinik Köln | Cologne | 50937 | Germany |
| Universitätsklinikum Carl Gustav Carus an der TU Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| SRH Wald-Klinikum Gera GmbH | Gera | 07548 | Germany |
| Medizinische Hochschule Hannover (Hannover Medical School) | Hanover | 30625 | Germany |
| University Clinic Heidelberg - PPDS | Heidelberg | 69120 | Germany |
| Universitatsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Universitatsklinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Fachklinik Hornheide | Münster | 48157 | Germany |
| Klinikum Nuernberg Nord | Nuremberg | 90419 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Universit*ätsklinikum Ulm | Ulm | 89081 | Germany |
| Laiko General Hospital of Athens | Athens | 115 27 | Greece |
| Magyar Honvédség Egészségügyi Központ | Budapest | 01062 | Hungary |
| Orszagos Onkologiai Intezet | Budapest | H-1122 | Hungary |
| Somogy Megyei Kaposi Mór Oktató Kórház | Kaposvár | 07400 | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet | Szolnok | 05004 | Hungary |
| Rambam Medical Center - PPDS | Haifa | 3109601 | Israel |
| Hadassah Medical Center - PPDS | Jerusalem | 91120 | Israel |
| Sheba Medical Center - PPDS | Ramat Gan | 5262100 | Israel |
| AOU dell'Università degli Studi della Campania Luigi Vanvitelli | Naples | Campania | 80138 | Italy |
| Istituto Dermopatico dell'Immacolata IRCCS | Rome | Lazio | 00167 | Italy |
| ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia | Brescia | Lombardy | 25123 | Italy |
| Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale | Naples | Naples | 80131 | Italy |
| Istituto Oncologico Veneto - I.R.C.C.S. | Padova | Veneto | 35128 | Italy |
| IRCCS Giovanni Paolo II Istituto Oncologico | Bari | 70126 | Italy |
| ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24129 | Italy |
| IRCCS Az. Osp. Universitaria San Martino- IST | Genova | 16132 | Italy |
| Ospedale San Raffaele S.r.l. - PPDS | Milan | 20132 | Italy |
| Fondazione IRCCS 'Istituto Nazionale dei Tumori' di Milano | Milan | 20133 | Italy |
| Istituto Nazionale Tumori Regina Elena | Roma | 00144 | Italy |
| Azienza Ospedaliera Universitaria Senese | Siena | 53100 | Italy |
| A.O.U. Città della Salute e della Scienza di Torino - Presidio S. Lazzaro | Torino | 10126 | Italy |
| Shinshu University Hospital | Matsumoto | Nagano | 390-8621 | Japan |
| National Cancer Center Hospital | Chūōku | 1040045 | Japan |
| Kansai Medical University Hospital | Hirakata | 573-1191 | Japan |
| Radboud University Nijmegen Medical Centre | Nijmegen | Gelderland | 6525 GA | Netherlands |
| Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis | Amsterdam | North Holland | 1066 CX | Netherlands |
| Leids Universitair Medisch Centrum | Leiden | South Holland | 2333ZA | Netherlands |
| Isala Klinieken | Zwolle | 8025 AB | Netherlands |
| Centrum Medyczne MAVIT Sp. z o.o. | Warsaw | Masovian Voivodeship | 01-673 | Poland |
| Lux Med | Warsaw | 02-676 | Poland |
| Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. | Lisbon | Lisbon District | 1099-023 | Portugal |
| Hospital Garcia de Orta*E.P.E. | Almada | 2801-951 | Portugal |
| Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS | Porto | 4200-072 | Portugal |
| Russian Oncology Research Center n a N N Blokhin | Moscow | 115478 | Russia |
| Ryazan Regional Clinical Oncology Dispensary | Ryazan | 390011 | Russia |
| Scientific Research Institute of Oncology n.a. N.N. Petrov | Saint Petersburg | 197758 | Russia |
| Narodny onkologicky ustav | Bratislava | 833 01 | Slovakia |
| University of The Free State | Bloemfontein | Free State | 09301 | South Africa |
| Sandton Oncology Medical Group | Johannesburg | Gauteng | 02196 | South Africa |
| Sandton Oncology Medical Research | Johannesburg | Gauteng | 02199 | South Africa |
| Steve Biko Academic Hospital | Pretoria | Gauteng | 00002 | South Africa |
| Mary Potter Oncology Centre | Pretoria | Gauteng | 00027 | South Africa |
| Asan Medical Center - PPDS | Seoul | 05505 | South Korea |
| Samsung Medical Center - PPDS | Seoul | 06351 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Severance Hospital Yonsei University Health System - PPDS | Seoul | 3722 | South Korea |
| ICO l'Hospitalet - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Regional Universitario de Malaga Hospital General | Málaga | Málaga | 29010 | Spain |
| Clinica Universidad Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital Universitario Vall d'Hebrón - PPDS | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| ICO l'Hospitalet - Hospital Duran i Reynals | Barcelona | 08907 | Spain |
| Complejo Hospitalario Universitario Insular - Materno Infantil | Gran Canaria | 35001 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28009 | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario HM Sanchinarro - CIOCC | Madrid | 28050 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Virgen de La Salud | Toledo | 45004 | Spain |
| Fundacion Instituto Valenciano de Oncologia | Valencia | 46009 | Spain |
| Consorcio Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Skanes Universitetssjukhus Lund | Lund | Skåne County | Sweden |
| Skanes Universitetssjukhus Lund | Lund | 221 85 | Sweden |
| Universitätsspital Zürich | Zurich | Zürich (DE) | 08091 | Switzerland |
| Hôpitaux Universitaires de Genève | Geneva | 01211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | 01011 | Switzerland |
| Ege University Medical Faculty | Bornova | İzmir | 35100 | Turkey (Türkiye) |
| Adana Ba?kent Hastanesi K??la Yerle?kesi | Adana | 01230 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Baskent University Medical Faculty Ankara Hospital | Ankara | 06490 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty Hospital | Istanbul | 34098 | Turkey (Türkiye) |
| Bristol Haematology and Oncology Centre | Bristol | Bristol, CITY of | BS2 8ED | United Kingdom |
| Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom |
| The Royal Sussex County Hospital | Brighton | EAST Sussex | BN2 5BE | United Kingdom |
| Broomfield Hospital | Chelmsford | Essex | CM1 7ET | United Kingdom |
| Singleton Hospital - PPDS | Swansea | Glamorgan | SA2 8QA | United Kingdom |
| Royal Preston Hospital | Preston | Lancashire | PR2 9HT | United Kingdom |
| Royal Marsden Hospital - Surrey | London | London, CITY of | SW3 6JJ | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| St James s Institute of Clinical Oncology | Leeds | LS9 7TF | United Kingdom |
| Clatterbridge Hospital | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| FG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
| Treated/Safety Set |
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| Full Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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| Follow up Phase |
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Full analysis set (FAS) included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Binimetinib (MEK162) | Participants received oral binimetinib 45 milligram (mg) (3*15 mg tablets) twice daily, until disease progression (PD), unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of binimetinib treatment exposure in the study was 215.4 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per Blinded Independent Review Committee (BIRC), withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
| BG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | PFS: time from randomization to first documented PD or death due to any cause, whichever occurred first. RECIST 1.1, PD: >=20% increase in sum of diameter of target lesions (TLs) taking as reference the smallest sum on study (including baseline sum), sum must also be an absolute increase of >=5 mm; unequivocal progression of existing non-TLs; appearance of >=1 lesion. Complete response (CR): disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs. Partial response (PR): >=30% decrease in sum of diameter of all TLs, referring baseline sum of diameters. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor increase in lesions qualified for PD referring smallest sum diameter. With no event at time of analysis cut-off or at start of any new anti-neoplastic therapy, PFS censored at date of last adequate tumor assessment of CR, PR or SD. | FAS consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the date of the first documented PD or death, whichever occurred first (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm) |
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| Secondary | Overall Survival (OS) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a participant was not known to have died, overall survival was censored at the date of last known date participant alive. | FAS consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the date of death (maximum up to 107 weeks for binimetinib arm; maximum up to 88 weeks for dacarbazine arm) |
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| Secondary | Overall Response Rate (ORR) | ORR: percentage of participants with best overall response (BOR) of CR or PR. BOR: best response recorded from start of treatment until CR or PR. RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter of all TLs, taking as reference baseline sum of diameters. ORR is reported for confirmed and unconfirmed responses. Confirmed CR or PR = at least 2 determinations of CR or PR at least 4 weeks apart before PD. PD: >=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all TLs recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion. | FAS consisted of all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From date of randomization until first documented response of CR or PR (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm) |
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| Secondary | Time to Response (TTR) | TTR: time between date of randomization until first documented response of CR or PR. RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter (dia) of all TLs, referring baseline sum of dia; c) PD: >=20% increase in sum of diameter of all measured TLs taking as reference smallest sum of diameter of all TLs recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-TLs. Appearance of >=1 new lesion. Participants who did not achieve PR or CR censored at last adequate tumor assessment date when they did not have PFS event (time from date of randomization to date of first documented PD or death due to any cause, whichever occur first) or at maximum follow-up when they had PFS event. | Analysis population consisted of all randomized participants and who had at least once CR or PR. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until first documented response of CR or PR (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm) |
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| Secondary | Duration of Objective Response (DOR) | DOR: time from date of first documented response (CR or PR) to first documented progression or death due to underlying cancer. RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter (dia) of all TLs, referring baseline sum of dia; c) PD: >=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 must also be absolute increase of >=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion. If a participant with a CR or PR had no PD or death due to underlying cancer, participants was censored at date of last adequate tumor assessment. | Analysis population consisted of all randomized participants and who had confirmed responses (CR or PR). | Posted | Median | 95% Confidence Interval | Months | From the date of first documented response (CR or PR) to the first documented progression or death (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm) |
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| Secondary | Disease Control Rate (DCR) | DCR was calculated as the percentage of participants with a BOR of CR, PR, SD RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; c) SD: neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD taking as reference the smallest sum diameters; d) PD: >=20% increase in 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, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion. | FAS consisted of all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization until first documented response of CR, PR, SD or non-CR/non-PD (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs. | The safety set consisted all participants who received at least one dose of the study drug and had at least one valid post-baseline safety evaluation. | Posted | Count of Participants | Participants | From baseline up to 219.4 weeks for binimetinib arm; From baseline up to 123.9 weeks for dacarbazine arm |
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| Secondary | Number of Participants With Clinically Notable Hematology Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.03 | Clinically notable shifts are defined as worsening by at least 2 grades or to >= grade 3. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. | The safety set consisted all participants who received at least one dose of the study drug and had at least one valid post-baseline safety evaluation. | Posted | Count of Participants | Participants | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
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| Secondary | Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on NCI-CTCAE Grade, Version 4.03 | Clinically notable shifts are defined as worsening by at least 2 grades or to >= grade 3. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. | The safety set consisted all participants who received at least one dose of the study drug and had at least one valid post-baseline safety evaluation. | Posted | Count of Participants | Participants | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
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| Secondary | Number of Participants With Clinically Notable Vital Signs | Abnormalities criteria included: low/high pulse rate (beats per minute [bpm]):<=50bpm with decrease from baseline >=15bpm/>=120bpm with increase from baseline >=15bpm; Low/high systolic blood pressure (millimeters of mercury [mmHg]): <=90mmHg with decrease from baseline >=20mmHg/>=160mmHg with increase from baseline >=20mmHg; Low/high diastolic blood pressure [mmHg]: <=50mmHg with decrease from baseline >=15mmHg/>=100mmHg with increase from baseline >=15mmHg; Low/high body weight (kilogram [kg]): >=20% decrease from baseline / >=10% increase from baseline; Low/high body temperature (degree Celsius [°C]): <=36°C / >= 37.5°C | The safety set consisted all participants who received at least one dose of the study drug and had at least one valid post-baseline safety evaluation. Here, "number analyzed" signifies participants evaluable for this outcome measure for specified rows. | Posted | Count of Participants | Participants | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
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| Secondary | Number of Participants With Notable Electrocardiogram (ECG) Values | Criteria for notable ECG values were as follow: QT interval (in millisecond [msec]) new (newly occurring post-baseline value) greater than (>) 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Fredericia formula (QTcF) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Bazett's formula (QTcB) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; heart rate in bpm new (newly occurring post-baseline value) <60 and >100. | The safety set consisted all participants who received at least one dose of the study drug and had at least one valid post-baseline safety evaluation. Here, "number analyzed" signifies participants evaluable for this outcome measure for specified rows. | Posted | Count of Participants | Participants | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
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| Secondary | Number of Participants With Adverse Events of Special Interest: Cardiac Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Here, in this outcome measure data is reported for events falling in any of the grades. | The safety set consisted all participants who received at least one dose of the study drug and had at least one valid post-baseline safety evaluation. | Posted | Count of Participants | Participants | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
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| Secondary | Number of Participants With Clinically Significant Findings in Physical Examination | A complete physical examination included the examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lungs, heart, abdomen, back, lymph nodes, extremities, vascular and neurological systems. If indicated based on medical history and/or symptoms, rectal, external genitalia, breast, and pelvic examinations were performed. Clinical significance in physical examination was reported as adverse events. | No data was collected and analyzed for this outcome measure, any clinically significant physical examination findings were counted as adverse events and reported in safety section. | Posted | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
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| Secondary | Number of Participants With Adverse Events of Special Interest: Ocular Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. Grade 1: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL; Grade 3: Severe or medically significant but not immediately sight threatening; Hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Sight-threatening consequences; urgent intervention indicated; blindness (20/200 or worse) in the affected eye. Here, in this outcome measure data is reported for events falling in any of the grades. | The safety set consisted all participants who received at least one dose of the study drug and had at least one valid post-baseline safety evaluation. | Posted | Count of Participants | Participants | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
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| Secondary | Plasma Concentration of Binimetinib | The pharmacokinetic analysis set (PAS) consisted of all participants who received at least one dose of binimetinib and had at least one evaluable post-baseline binimetinib concentration measurement. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. This outcome was planned to be evaluated only for binimetinib arm. Here, "number analyzed" signifies participants evaluable for this outcome measure for specified timeframes. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Day 1 of Week 1: Pre-dose, 1, 1.5, 2, 10 hours post-dose; Day 1 of Weeks 4, 7: Pre-dose, 1.5 hours post-dose; Day 1 of Weeks 10, 13: Pre-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Definitive 10% Deterioration in Global Health Status Score of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) | The time to definitive 10% deterioration was defined as the time from the date of randomization to the date of event, which was defined as death due to any cause or at least 10% worsening of the corresponding scale score, relative to baseline, with no later improvement above this threshold observed during the course of the study or death due to any cause. If a participant had no event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last adequate health related quality of life (HRQoL) evaluation. EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status scale, 3 symptom scales (nausea/vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range =0 to 100. High score for global health status = high quality of life. | FAS consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm |
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| Secondary | Change From Baseline in Global Health Status Score of EORTC QLQ-C30 at Weeks 4, 7, 13, 19, 25, 34, 43, 52, 61, 70, End of Treatment, Safety Follow-up Visit, Post-Treatment Follow-up Visit 1, 2, 3, 4, 5 and 6 | EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a h global health status scale, 3 symptom scales (nausea/vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range =0 to 100. High score for global health status = high quality of life. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy. | FAS consisted of all randomized participants. Here, "Number analyzed" signifies number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Both arms: Baseline, Day 1 Treatment Week (TW) 4,7,13,19,25,34,43,52; Post-treatment follow-up Visit (FUV) 1 to 6; Binimetinib: Day 1 TW61,70; End of treatment (EOT= TW73); Safety FUV=30 days post TW73; Dacarbazine: EOT=TW 57;Safety FUV=30 days post TW57 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQoL-5 Dimensions- 5 Levels (EQ-5D-5L) Index Score at Weeks 4, 7, 13, 19, 25, 34, 43, 52, 61, 70, End of Treatment, Safety Follow-up Visit, Post-treatment Follow-up Visit 1, 2, 3, 4, 5 and 6 | EQ-5D-5L, is a standardized measure of health utility that provides a single index value for one's health status. EQ-5D-5L contained 1 item for each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Index score: participant responses to the 5 dimensions reflected a specific health state that corresponded to a population preference weight for that state on a continuous scale of 0 (death) to 1 (perfect health). Higher index scores = better health state. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy. | FAS consisted of all randomized participants. Here, "Number analyzed" signifies number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Units on a scale | Both arms: Baseline, Day 1 Treatment Week (TW) 4,7,13,19,25,34,43,52; Post-treatment follow-up Visit (FUV) 1 to 6; Binimetinib: Day 1 TW61,70; End of treatment (EOT= TW73); Safety FUV=30 days post TW73; Dacarbazine: EOT=TW 57;Safety FUV=30 days post TW57 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Definitive 1 Point Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | ECOG PS was used to assess the physical health of participants, and ranged from 0 (most active) to 5 (dead). ECOG PS grades: 0= fully active, able to carry on all pre-disease performance without restriction, 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4=completely disabled. cannot carry on any selfcare. Totally confined to bed or chair and 5= dead. Definitive deterioration is defined as on treatment death due to any cause or decrease in ECOG PS by at least one category from baseline score. | The safety set consisted all participants who received at least one dose of the study drug and had at least one valid post-baseline safety evaluation. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From baseline up to 73 weeks 3 days for binimetinib arm; From baseline up to 57 weeks 3 days for dacarbazine arm |
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| Secondary | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | ECOG PS was used to assess the physical health of participants, and ranged from 0 (most active) to 5 (dead). ECOG PS grades: 0= fully active, able to carry on all pre-disease performance without restriction, 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4=completely disabled. cannot carry on any selfcare. Totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy. | The safety set consisted all participants who received at least one dose of the study drug and had at least one valid post-baseline safety evaluation. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | For both arms: Baseline, Weeks 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55 and 30-day Follow-up For binimetinib only: Weeks 58, 61, 64, 67, 70, 73 |
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| Secondary | Number of Participants With Neuroblastoma RAS Viral (V-ras) Oncogene Homolog (NRAS) Mutation Status at Baseline | Number of participants with NRAS mutation status at baseline were reported. | FAS consisted of all randomized participants. Here, "number analyzed" signifies participants evaluable for this outcome measure for specified rows. | Posted | Count of Participants | Participants | Baseline |
|
From baseline up to 219.4 weeks for binimetinib arm; From baseline up to 123.9 weeks for dacarbazine arm
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who have received at least one dose of the study drug and had at least one valid 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 oral binimetinib 45 milligram (mg) (3*15 mg tablets) twice daily, until disease progression (PD), unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of binimetinib treatment exposure in the study was 215.4 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per Blinded Independent Review Committee (BIRC), withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. | 95 | 269 | 266 | 269 | ||
| EG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. | 26 | 114 | 100 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| TACHYARRHYTHMIA | Cardiac disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RETINAL VEIN OCCLUSION | Eye disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MALAISE | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MUSCLE INJURY | Injury, poisoning and procedural complications | MedDRA v 19.0 | Non-systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MYASTHENIC SYNDROME | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PERIPHERAL SENSORIMOTOR NEUROPATHY | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MALIGNANT ASCITES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | Cardiac disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MITRAL VALVE DISEASE | Cardiac disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RETINAL VEIN THROMBOSIS | Eye disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| AUTOIMMUNE PANCREATITIS | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DUODENAL PERFORATION | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| INTUSSUSCEPTION | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MESENTERIC VEIN THROMBOSIS | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SUBILEUS | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| AXILLARY PAIN | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| CHOLESTASIS | Hepatobiliary disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DERMO-HYPODERMITIS | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PNEUMOCOCCAL SEPSIS | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PERINEAL ABSCESS | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA v 19.0 | Non-systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA v 19.0 | Non-systematic Assessment |
| |
| BLOOD PRESSURE INCREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| GENERAL PHYSICAL CONDITION ABNORMAL | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DIABETIC METABOLIC DECOMPENSATION | Metabolism and nutrition disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| INTERVERTEBRAL DISC COMPRESSION | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DROPPED HEAD SYNDROME | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MOTOR DYSFUNCTION | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PROGRESSIVE SUPRANUCLEAR PALSY | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HAEMORRHAGE | Vascular disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| AORTIC DILATATION | Vascular disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ABNORMAL BEHAVIOUR | Psychiatric disorders | MedDRA v 19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| EYELID OEDEMA | Eye disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SUBRETINAL FLUID | Eye disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MACULAR OEDEMA | Eye disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PERIORBITAL OEDEMA | Eye disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| FACE OEDEMA | General disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| SKIN FISSURES | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA v 19.0 | Non-systematic Assessment |
| |
| RASH PUSTULAR | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA v 19.0 | Non-systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA v 19.0 | 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 |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008545 | Melanoma |
| D012871 | Skin Diseases |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C581313 | binimetinib |
| D003606 | Dacarbazine |
| ID | Term |
|---|---|
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Subject/guardian decision |
|
| Progressive disease |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| Male |
|
|
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 |
| Dacarbazine |
Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
|
| OG001 | Dacarbazine | Participants received intravenous (IV) dacarbazine 1000 mg per square meter (mg/m^2) once every 3 weeks until PD, unacceptable toxicity, death, physician decision, study termination or discontinuation due to any other reason (e.g., withdrawal of consent, lost to follow-up, start of a new anti-cancer therapy). Maximum duration of dacarbazine treatment exposure in the study was 119.9 weeks and participants were followed up to 30 days after last dose of study treatment. Participants who discontinued study treatment due to start of a new anti-cancer therapy, were followed up at every 9 weeks until documented progression per BIRC, withdrawal of consent, lost to follow-up, study closure or death whichever occurred first. |
|
|
|
|