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Trial record 2 of 2 for:    "milo" "ovarian"

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT01849874
Recruitment Status : Active, not recruiting
First Posted : May 9, 2013
Results First Posted : March 30, 2021
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Low-grade Serous Ovarian Cancer
Low-grade Serous Fallopian Tube Cancer
Low-grade Serous Peritoneal Cancer
Interventions Drug: MEK162, MEK inhibitor; oral
Drug: Physician's choice chemotherapy
Enrollment 341
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MEK162 Physician's Choice
Hide Arm/Group Description Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug. Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
Period Title: Overall Study
Started 201 102
Treated 200 94
Completed 0 0
Not Completed 201 102
Reason Not Completed
Death             34             16
Withdrawal by Subject             4             8
Lost to Follow-up             0             1
Randomized but Never Treated             1             8
Ongoing             162             69
Arm/Group Title MEK162 Physician's Choice Total
Hide Arm/Group Description Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug. Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug. Total of all reporting groups
Overall Number of Baseline Participants 201 102 303
Hide Baseline Analysis Population Description
The full analysis set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants 102 participants 303 participants
51.6  (14.5) 50.2  (13.6) 51.1  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 102 participants 303 participants
Female
201
 100.0%
102
 100.0%
303
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Hide Description PFS was defined as the time from randomization to the earliest documented disease progression date or death due to any cause whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of greater than or equal to (>=) 5 millimeter (mm). Appearance of new lesions >=10 mm in diameter also constituted PD. If a participant did not have an event at the time of the analysis cutoff or at the start of any new therapy, PFS was censored at the date of last adequate tumor assessment.
Time Frame From randomization until documented progressive disease (PD) or death, whichever occurred first, for censored participants at the date of last adequate tumor assessment (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants.
Arm/Group Title MEK162 Physician's Choice
Hide Arm/Group Description:
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
Overall Number of Participants Analyzed 201 102
Median (95% Confidence Interval)
Unit of Measure: months
9.10
(7.29 to 11.30)
10.58
(9.20 to 14.52)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from randomization to death due to any cause. Participants who were alive at the data cutoff date were censored for overall survival at their last contact date.
Time Frame From randomization date to the date of death, for censored participants at their last contact date (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants.
Arm/Group Title MEK162 Physician's Choice
Hide Arm/Group Description:
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
Overall Number of Participants Analyzed 201 102
Median (95% Confidence Interval)
Unit of Measure: months
25.33 [1] 
(18.46 to NA)
20.83 [1] 
(17.45 to NA)
[1]
Upper limit of 95% CI was not estimable due to low number of participants with events.
3.Secondary Outcome
Title Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1)
Hide Description ORR was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR) (responders). CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 mm, PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease.
Time Frame From randomization until disease progression or death (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants with measurable disease at baseline per BICR.
Arm/Group Title MEK162 Physician's Choice
Hide Arm/Group Description:
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
Overall Number of Participants Analyzed 198 101
Measure Type: Number
Unit of Measure: percentage of participants
16 13
4.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined as the time from first radiographic evidence of response to the earliest documented progression date or death due to any cause, and was calculated on responders only. Responders with no PD or death date or subsequent anticancer therapy by the data cutoff date, were censored for DOR at their last radiological assessment. Responders who received subsequent anticancer therapy prior to PD or death were censored at their last radiological assessment prior to initiation of subsequent anticancer therapy.
Time Frame From the first radiographic evidence of response to the first documentation of PD or death, for censored participants at their last radiological assessment (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants with measurable disease at baseline per BICR. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title MEK162 Physician's Choice
Hide Arm/Group Description:
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
Overall Number of Participants Analyzed 23 8
Median (Full Range)
Unit of Measure: months
8.05
(0.03 to 11.99)
6.67
(0.03 to 9.69)
5.Secondary Outcome
Title Disease Control Rate
Hide Description Disease control rate was defined as percentage of participants with disease control. Disease control was defined as a best response of CR or PR, or stable disease (SD) documented at Week 24 or later. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm, and PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the lack of follow-up data at the time of data cut-off, data for this outcome measure was not collected.
Arm/Group Title MEK162 Physician's Choice
Hide Arm/Group Description:
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame From the first dose of study drug until 30 days after the last dose (up to 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set included all participants who received at least 1 dose of study drug and had at least 1 post-treatment assessment, including death.
Arm/Group Title MEK162 Physician's Choice
Hide Arm/Group Description:
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
Overall Number of Participants Analyzed 200 94
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
194
  97.0%
92
  97.9%
SAEs
86
  43.0%
20
  21.3%
7.Secondary Outcome
Title Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.3
Hide Description Number of participants with shifts from normal Baseline values (Grade 0) to abnormal post-baseline values (shift to greater than or equal to Grade 3) were reported as per NCI-CTCAE, V4.3 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. Shifts in lab parameter from Grade 0 to 3, Grade 0 to 4 and Grade 0 to Low 3 and 4 and Grade 0 to High 3 and 4 (for parameters total hemoglobin, lymphocytes, white blood cells, calcium, magnesium, potassium, and sodium) were reported.
Time Frame From the first dose of study drug until 30 days after the last dose (up to 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all participants who received at least 1 dose of study drug and had at least 1 post-treatment assessment, including death.
Arm/Group Title MEK162 Physician's Choice
Hide Arm/Group Description:
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
Overall Number of Participants Analyzed 200 94
Measure Type: Count of Participants
Unit of Measure: Participants
International Normalized Ratio: Grade 0 to 3
0
   0.0%
0
   0.0%
International Normalized Ratio: Grade 0 to 4
0
   0.0%
0
   0.0%
Neutrophils: Grade 0 to 3
1
   0.5%
4
   4.3%
Neutrophils: Grade 0 to 4
0
   0.0%
1
   1.1%
Platelet Count: Grade 0 to 3
0
   0.0%
0
   0.0%
Platelet Count: Grade 0 to 4
1
   0.5%
0
   0.0%
Partial Thromboplastin Time: Grade 0 to 3
2
   1.0%
1
   1.1%
Partial Thromboplastin Time: Grade 0 to 4
0
   0.0%
0
   0.0%
Total Hemoglobin: Grade 0 to Low 3
7
   3.5%
0
   0.0%
Total Hemoglobin: Grade 0 to Low 4
0
   0.0%
0
   0.0%
Total Hemoglobin: Grade 0 to High 3
0
   0.0%
0
   0.0%
Total Hemoglobin: Grade 0 to High 4
0
   0.0%
0
   0.0%
Lymphocytes: Grade 0 to Low 3
1
   0.5%
3
   3.2%
Lymphocytes: Grade 0 to Low 4
1
   0.5%
0
   0.0%
Lymphocytes: Grade 0 to High 3
0
   0.0%
0
   0.0%
Lymphocytes: Grade 0 to High 4
0
   0.0%
0
   0.0%
White Blood Cells: Grade 0 to Low 3
0
   0.0%
0
   0.0%
White Blood Cells: Grade 0 to Low 4
0
   0.0%
1
   1.1%
White Blood Cells: Grade 0 to High 3
0
   0.0%
0
   0.0%
White Blood Cells: Grade 0 to High 4
0
   0.0%
0
   0.0%
Albumin: Grade 0 to 3
1
   0.5%
0
   0.0%
Albumin: Grade 0 to 4
0
   0.0%
0
   0.0%
Alkaline Phosphatase: Grade 0 to 3
2
   1.0%
1
   1.1%
Alkaline Phosphatase: Grade 0 to 4
0
   0.0%
0
   0.0%
Alanine Aminotransferase/Serum Glutamic-pyruvic Transaminase: Grade 0 to 3
5
   2.5%
0
   0.0%
Alanine Aminotransferase/Serum Glutamic-pyruvic Transaminase: Grade 0 to 4
0
   0.0%
0
   0.0%
Aspartate Aminotransferase/Serum Glutamic-oxaloacetic Transaminase: Grade 0 to 3
4
   2.0%
0
   0.0%
Aspartate Aminotransferase/Serum Glutamic-oxaloacetic Transaminase: Grade 0 to 4
0
   0.0%
0
   0.0%
Creatine Kinase: Grade 0 to 3
43
  21.5%
0
   0.0%
Creatine Kinase: Grade 0 to 4
9
   4.5%
0
   0.0%
Serum Creatinine: Grade 0 to 3
1
   0.5%
0
   0.0%
Serum Creatinine: Grade 0 to 4
0
   0.0%
0
   0.0%
Total Bilirubin: Grade 0 to 3
1
   0.5%
0
   0.0%
Total Bilirubin: Grade 0 to 4
0
   0.0%
0
   0.0%
Calcium: Grade 0 to Low 3
0
   0.0%
1
   1.1%
Calcium: Grade 0 to Low 4
1
   0.5%
0
   0.0%
Calcium: Grade 0 to High 3
1
   0.5%
0
   0.0%
Calcium: Grade 0 to High 4
0
   0.0%
0
   0.0%
Magnesium: Grade 0 to Low 3
0
   0.0%
1
   1.1%
Magnesium: Grade 0 to Low 4
0
   0.0%
0
   0.0%
Magnesium: Grade 0 to High 3
0
   0.0%
0
   0.0%
Magnesium: Grade 0 to High 4
0
   0.0%
0
   0.0%
Potassium: Grade 0 to Low 3
4
   2.0%
2
   2.1%
Potassium: Grade 0 to Low 4
0
   0.0%
0
   0.0%
Potassium: Grade 0 to High 3
1
   0.5%
1
   1.1%
Potassium: Grade 0 to High 4
0
   0.0%
0
   0.0%
Sodium: Grade 0 to Low 3
2
   1.0%
0
   0.0%
Sodium: Grade 0 to Low 4
1
   0.5%
0
   0.0%
Sodium: Grade 0 to High 3
3
   1.5%
0
   0.0%
Sodium: Grade 0 to High 4
1
   0.5%
0
   0.0%
Time Frame From the first dose of study drug until 30 days after the last dose (up to 25 months)
Adverse Event Reporting Description Same event may appear as an 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. The safety set included all participants who received at least 1 dose of study drug and have at least 1 post-treatment assessment, including death.
 
Arm/Group Title MEK162 Physician's Choice
Hide Arm/Group Description Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study drug. Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one among the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study drug.
All-Cause Mortality
MEK162 Physician's Choice
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
MEK162 Physician's Choice
Affected / at Risk (%) Affected / at Risk (%)
Total   86/200 (43.00%)   20/94 (21.28%) 
Blood and lymphatic system disorders     
Anaemia * 1  7/200 (3.50%)  1/94 (1.06%) 
Haemolytic uraemic syndrome * 1  1/200 (0.50%)  0/94 (0.00%) 
Thrombotic thrombocytopenic purpura * 1  1/200 (0.50%)  0/94 (0.00%) 
Cardiac disorders     
Atrial thrombosis * 1  0/200 (0.00%)  1/94 (1.06%) 
Cardiac arrest * 1  1/200 (0.50%)  0/94 (0.00%) 
Cardiac failure * 1  0/200 (0.00%)  1/94 (1.06%) 
Stress cardiomyopathy * 1  1/200 (0.50%)  0/94 (0.00%) 
Tachycardia * 1  1/200 (0.50%)  0/94 (0.00%) 
Eye disorders     
Retinal vein occlusion * 1  3/200 (1.50%)  0/94 (0.00%) 
Choroiditis * 1  1/200 (0.50%)  0/94 (0.00%) 
Retinal oedema * 1  1/200 (0.50%)  0/94 (0.00%) 
Retinal vein thrombosis * 1  1/200 (0.50%)  0/94 (0.00%) 
Vision blurred * 1  1/200 (0.50%)  0/94 (0.00%) 
Visual acuity reduced * 1  1/200 (0.50%)  0/94 (0.00%) 
Gastrointestinal disorders     
Small intestinal obstruction * 1  9/200 (4.50%)  5/94 (5.32%) 
Vomiting * 1  13/200 (6.50%)  1/94 (1.06%) 
Intestinal obstruction * 1  10/200 (5.00%)  3/94 (3.19%) 
Ascites * 1  5/200 (2.50%)  3/94 (3.19%) 
Diarrhoea * 1  7/200 (3.50%)  0/94 (0.00%) 
Abdominal pain * 1  5/200 (2.50%)  1/94 (1.06%) 
Nausea * 1  5/200 (2.50%)  0/94 (0.00%) 
Colonic obstruction * 1  3/200 (1.50%)  0/94 (0.00%) 
Constipation * 1  2/200 (1.00%)  0/94 (0.00%) 
Gastrointestinal haemorrhage * 1  2/200 (1.00%)  0/94 (0.00%) 
Large intestinal obstruction * 1  2/200 (1.00%)  0/94 (0.00%) 
Subileus * 1  2/200 (1.00%)  0/94 (0.00%) 
Upper gastrointestinal haemorrhage * 1  2/200 (1.00%)  0/94 (0.00%) 
Abdominal distension * 1  0/200 (0.00%)  1/94 (1.06%) 
Anal haemorrhage * 1  1/200 (0.50%)  0/94 (0.00%) 
Duodenal ulcer perforation * 1  1/200 (0.50%)  0/94 (0.00%) 
Gastric haemorrhage * 1  1/200 (0.50%)  0/94 (0.00%) 
Gastrointestinal obstruction * 1  1/200 (0.50%)  0/94 (0.00%) 
Gastrointestinal perforation * 1  1/200 (0.50%)  0/94 (0.00%) 
Gastrointestinal ulcer * 1  1/200 (0.50%)  0/94 (0.00%) 
Ileal perforation * 1  1/200 (0.50%)  0/94 (0.00%) 
Ileus * 1  1/200 (0.50%)  0/94 (0.00%) 
Large intestine perforation * 1  1/200 (0.50%)  0/94 (0.00%) 
Oesophagitis ulcerative * 1  1/200 (0.50%)  0/94 (0.00%) 
Pancreatitis * 1  1/200 (0.50%)  0/94 (0.00%) 
Rectal haemorrhage * 1  1/200 (0.50%)  0/94 (0.00%) 
Small intestinal perforation * 1  1/200 (0.50%)  0/94 (0.00%) 
General disorders     
Death * 1  3/200 (1.50%)  1/94 (1.06%) 
Asthenia * 1  2/200 (1.00%)  1/94 (1.06%) 
Pyrexia * 1  1/200 (0.50%)  1/94 (1.06%) 
Fatigue * 1  1/200 (0.50%)  0/94 (0.00%) 
Immune system disorders     
Drug hypersensitivity * 1  0/200 (0.00%)  1/94 (1.06%) 
Infections and infestations     
Sepsis * 1  5/200 (2.50%)  1/94 (1.06%) 
Urinary tract infection * 1  6/200 (3.00%)  0/94 (0.00%) 
Lung infection * 1  3/200 (1.50%)  0/94 (0.00%) 
Device related infection * 1  0/200 (0.00%)  2/94 (2.13%) 
Pneumonia * 1  1/200 (0.50%)  1/94 (1.06%) 
Pyelonephritis * 1  2/200 (1.00%)  0/94 (0.00%) 
Bacteraemia * 1  1/200 (0.50%)  0/94 (0.00%) 
Catheter site cellulitis * 1  0/200 (0.00%)  1/94 (1.06%) 
Catheter site infection * 1  0/200 (0.00%)  1/94 (1.06%) 
Clostridium difficile infection * 1  1/200 (0.50%)  0/94 (0.00%) 
Cystitis * 1  1/200 (0.50%)  0/94 (0.00%) 
Enterocolitis infectious * 1  0/200 (0.00%)  1/94 (1.06%) 
Escherichia urinary tract infection * 1  1/200 (0.50%)  0/94 (0.00%) 
Fungal sepsis * 1  1/200 (0.50%)  0/94 (0.00%) 
Influenza * 1  1/200 (0.50%)  0/94 (0.00%) 
Kidney infection * 1  1/200 (0.50%)  0/94 (0.00%) 
Klebsiella sepsis * 1  1/200 (0.50%)  0/94 (0.00%) 
Lymph node tuberculosis * 1  1/200 (0.50%)  0/94 (0.00%) 
Peritonitis * 1  1/200 (0.50%)  0/94 (0.00%) 
Peritonitis bacterial * 1  1/200 (0.50%)  0/94 (0.00%) 
Pneumococcal bacteraemia * 1  1/200 (0.50%)  0/94 (0.00%) 
Pneumonia viral * 1  0/200 (0.00%)  1/94 (1.06%) 
Respiratory tract infection * 1  1/200 (0.50%)  0/94 (0.00%) 
Respiratory tract infection fungal * 1  1/200 (0.50%)  0/94 (0.00%) 
Staphylococcal bacteraemia * 1  1/200 (0.50%)  0/94 (0.00%) 
Streptococcal bacteraemia * 1  1/200 (0.50%)  0/94 (0.00%) 
Upper respiratory tract infection * 1  0/200 (0.00%)  1/94 (1.06%) 
Urosepsis * 1  0/200 (0.00%)  1/94 (1.06%) 
Injury, poisoning and procedural complications     
Feeding tube complication * 1  1/200 (0.50%)  0/94 (0.00%) 
Femur fracture * 1  0/200 (0.00%)  1/94 (1.06%) 
Fractured coccyx * 1  1/200 (0.50%)  0/94 (0.00%) 
Pelvic fracture * 1  1/200 (0.50%)  0/94 (0.00%) 
Investigations     
Blood creatine phosphokinase increased * 1  4/200 (2.00%)  0/94 (0.00%) 
Ejection fraction decreased * 1  1/200 (0.50%)  1/94 (1.06%) 
Blood creatinine increased * 1  1/200 (0.50%)  0/94 (0.00%) 
Troponin I increased * 1  1/200 (0.50%)  0/94 (0.00%) 
Troponin increased * 1  1/200 (0.50%)  0/94 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  3/200 (1.50%)  0/94 (0.00%) 
Decreased appetite * 1  1/200 (0.50%)  1/94 (1.06%) 
Hyperkalaemia * 1  1/200 (0.50%)  0/94 (0.00%) 
Hypocalcaemia * 1  0/200 (0.00%)  1/94 (1.06%) 
Malnutrition * 1  1/200 (0.50%)  0/94 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/200 (0.50%)  1/94 (1.06%) 
Muscular weakness * 1  0/200 (0.00%)  1/94 (1.06%) 
Pain in extremity * 1  0/200 (0.00%)  1/94 (1.06%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant pleural effusion * 1  1/200 (0.50%)  0/94 (0.00%) 
Metastases to central nervous system * 1  1/200 (0.50%)  0/94 (0.00%) 
Nervous system disorders     
Hemiparesis * 1  2/200 (1.00%)  0/94 (0.00%) 
Dizziness * 1  1/200 (0.50%)  0/94 (0.00%) 
Dropped head syndrome * 1  1/200 (0.50%)  0/94 (0.00%) 
Dysarthria * 1  1/200 (0.50%)  0/94 (0.00%) 
Headache * 1  0/200 (0.00%)  1/94 (1.06%) 
Myasthenia gravis * 1  1/200 (0.50%)  0/94 (0.00%) 
Optic neuritis * 1  1/200 (0.50%)  0/94 (0.00%) 
Paraesthesia * 1  1/200 (0.50%)  0/94 (0.00%) 
Psychiatric disorders     
Hallucination * 1  1/200 (0.50%)  0/94 (0.00%) 
Mental status changes * 1  1/200 (0.50%)  0/94 (0.00%) 
Panic reaction * 1  1/200 (0.50%)  0/94 (0.00%) 
Renal and urinary disorders     
Renal failure acute * 1  3/200 (1.50%)  0/94 (0.00%) 
Hydronephrosis * 1  1/200 (0.50%)  0/94 (0.00%) 
Nephrolithiasis * 1  1/200 (0.50%)  0/94 (0.00%) 
Renal impairment * 1  1/200 (0.50%)  0/94 (0.00%) 
Renal pain * 1  1/200 (0.50%)  0/94 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  5/200 (2.50%)  1/94 (1.06%) 
Pleural effusion * 1  3/200 (1.50%)  1/94 (1.06%) 
Dyspnoea * 1  1/200 (0.50%)  1/94 (1.06%) 
Pneumonia aspiration * 1  1/200 (0.50%)  1/94 (1.06%) 
Pneumonitis * 1  2/200 (1.00%)  0/94 (0.00%) 
Respiratory failure * 1  1/200 (0.50%)  0/94 (0.00%) 
Rhinitis allergic * 1  0/200 (0.00%)  1/94 (1.06%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular * 1  1/200 (0.50%)  0/94 (0.00%) 
Skin necrosis * 1  1/200 (0.50%)  0/94 (0.00%) 
Vascular disorders     
Hypotension * 1  1/200 (0.50%)  2/94 (2.13%) 
Deep vein thrombosis * 1  1/200 (0.50%)  0/94 (0.00%) 
Hypertension * 1  1/200 (0.50%)  0/94 (0.00%) 
Hypertensive crisis * 1  0/200 (0.00%)  1/94 (1.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MEK162 Physician's Choice
Affected / at Risk (%) Affected / at Risk (%)
Total   194/200 (97.00%)   92/94 (97.87%) 
Blood and lymphatic system disorders     
Anaemia * 1  31/200 (15.50%)  11/94 (11.70%) 
Neutropenia * 1  4/200 (2.00%)  9/94 (9.57%) 
Eye disorders     
Vision blurred * 1  39/200 (19.50%)  6/94 (6.38%) 
Retinal detachment * 1  31/200 (15.50%)  0/94 (0.00%) 
Dry eye * 1  15/200 (7.50%)  6/94 (6.38%) 
Eyelid oedema * 1  13/200 (6.50%)  0/94 (0.00%) 
Detachment of retinal pigment epithelium * 1  12/200 (6.00%)  0/94 (0.00%) 
Periorbital oedema * 1  11/200 (5.50%)  0/94 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  140/200 (70.00%)  30/94 (31.91%) 
Nausea * 1  109/200 (54.50%)  43/94 (45.74%) 
Vomiting * 1  106/200 (53.00%)  23/94 (24.47%) 
Abdominal pain * 1  60/200 (30.00%)  21/94 (22.34%) 
Constipation * 1  51/200 (25.50%)  25/94 (26.60%) 
Stomatitis * 1  46/200 (23.00%)  27/94 (28.72%) 
Dyspepsia * 1  27/200 (13.50%)  12/94 (12.77%) 
Dry mouth * 1  31/200 (15.50%)  6/94 (6.38%) 
Gastrooesophageal reflux disease * 1  18/200 (9.00%)  5/94 (5.32%) 
Abdominal distension * 1  17/200 (8.50%)  5/94 (5.32%) 
Abdominal pain upper * 1  13/200 (6.50%)  4/94 (4.26%) 
Ascites * 1  11/200 (5.50%)  3/94 (3.19%) 
Rectal haemorrhage * 1  8/200 (4.00%)  5/94 (5.32%) 
General disorders     
Fatigue * 1  97/200 (48.50%)  43/94 (45.74%) 
Oedema peripheral * 1  93/200 (46.50%)  8/94 (8.51%) 
Pyrexia * 1  26/200 (13.00%)  12/94 (12.77%) 
Asthenia * 1  26/200 (13.00%)  6/94 (6.38%) 
Face oedema * 1  23/200 (11.50%)  0/94 (0.00%) 
Chills * 1  14/200 (7.00%)  5/94 (5.32%) 
Non-cardiac chest pain * 1  10/200 (5.00%)  7/94 (7.45%) 
Infections and infestations     
Urinary tract infection * 1  32/200 (16.00%)  7/94 (7.45%) 
Upper respiratory tract infection * 1  12/200 (6.00%)  4/94 (4.26%) 
Rash pustular * 1  13/200 (6.50%)  1/94 (1.06%) 
Investigations     
Blood creatine phosphokinase increased * 1  98/200 (49.00%)  1/94 (1.06%) 
Ejection fraction decreased * 1  57/200 (28.50%)  10/94 (10.64%) 
Aspartate aminotransferase increased * 1  26/200 (13.00%)  1/94 (1.06%) 
Alanine aminotransferase increased * 1  21/200 (10.50%)  2/94 (2.13%) 
Weight increased * 1  15/200 (7.50%)  2/94 (2.13%) 
Weight decreased * 1  7/200 (3.50%)  7/94 (7.45%) 
Neutrophil count decreased * 1  3/200 (1.50%)  7/94 (7.45%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  44/200 (22.00%)  16/94 (17.02%) 
Hypomagnesaemia * 1  20/200 (10.00%)  3/94 (3.19%) 
Hypokalaemia * 1  18/200 (9.00%)  3/94 (3.19%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  34/200 (17.00%)  9/94 (9.57%) 
Back pain * 1  25/200 (12.50%)  10/94 (10.64%) 
Arthralgia * 1  27/200 (13.50%)  5/94 (5.32%) 
Pain in extremity * 1  15/200 (7.50%)  5/94 (5.32%) 
Muscular weakness * 1  14/200 (7.00%)  2/94 (2.13%) 
Muscle spasms * 1  13/200 (6.50%)  1/94 (1.06%) 
Nervous system disorders     
Headache * 1  35/200 (17.50%)  16/94 (17.02%) 
Dysgeusia * 1  22/200 (11.00%)  10/94 (10.64%) 
Dizziness * 1  24/200 (12.00%)  6/94 (6.38%) 
Neuropathy peripheral * 1  16/200 (8.00%)  11/94 (11.70%) 
Paraesthesia * 1  11/200 (5.50%)  4/94 (4.26%) 
Peripheral sensory neuropathy * 1  4/200 (2.00%)  7/94 (7.45%) 
Psychiatric disorders     
Insomnia * 1  29/200 (14.50%)  8/94 (8.51%) 
Anxiety * 1  18/200 (9.00%)  4/94 (4.26%) 
Depression * 1  16/200 (8.00%)  3/94 (3.19%) 
Renal and urinary disorders     
Haematuria * 1  12/200 (6.00%)  1/94 (1.06%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  30/200 (15.00%)  13/94 (13.83%) 
Cough * 1  18/200 (9.00%)  17/94 (18.09%) 
Oropharyngeal pain * 1  17/200 (8.50%)  7/94 (7.45%) 
Epistaxis * 1  14/200 (7.00%)  3/94 (3.19%) 
Dysphonia * 1  11/200 (5.50%)  2/94 (2.13%) 
Skin and subcutaneous tissue disorders     
Dermatitis acneiform * 1  92/200 (46.00%)  4/94 (4.26%) 
Alopecia * 1  50/200 (25.00%)  25/94 (26.60%) 
Dry skin * 1  56/200 (28.00%)  14/94 (14.89%) 
Rash maculo-papular * 1  45/200 (22.50%)  16/94 (17.02%) 
Pruritus * 1  41/200 (20.50%)  10/94 (10.64%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  9/200 (4.50%)  31/94 (32.98%) 
Rash * 1  22/200 (11.00%)  7/94 (7.45%) 
Skin fissures * 1  25/200 (12.50%)  1/94 (1.06%) 
Vascular disorders     
Hypertension * 1  37/200 (18.50%)  2/94 (2.13%) 
Hot flush * 1  13/200 (6.50%)  1/94 (1.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01849874    
Other Study ID Numbers: ARRAY-162-311
C4211003 ( Other Identifier: Alias Study Number )
2013-000277-72 ( EudraCT Number )
First Submitted: May 6, 2013
First Posted: May 9, 2013
Results First Submitted: March 3, 2021
Results First Posted: March 30, 2021
Last Update Posted: July 12, 2021