Trial · NCT01320085
A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma
NCT01320085, Phase 2, Completed, Pfizer; results first posted 2021-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma. Trials, record NCT01320085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01320085
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma
- NCT number
- NCT01320085
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 183 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- BRAF or NRAS Mutant Metastatic Melanoma
- Interventions
- MEK162
- First posted
- 2011-03-22
- Last updated
- 2024-01-24
- Other registries' IDs
- eudract:2010-023412-13
- Results first posted
- 2021-01-05
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response (OR) | From date of randomization or date of start of treatment until date of first documentation of PD or death due to any cause, whichever occurred first (maximum duration of up to 33 months) | Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.0, was defined as participants with a best overall response of complete response (CR) or partial response (PR), were recorded from date of randomization or date of start of treatment until date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target and non-target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Progression-Free Survival (PFS) | From date of randomization or date of start of treatment until date of first documentation of PD or date of death due to any cause or date of data censoring, whichever occurred first (maximum duration of up to 33 months) | PFS as assessed by investigator per RECIST v1.0, was defined as time (in months) from date of randomization or date of start of treatment to first documentation of PD or date of death due to any cause or data censoring date, whichever occurred first. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of greater than or equal to (\>=) 5 mm, or appearance of \>=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. If a participant did not had an event, data censoring was done at the date of last adequate tumor assessment. Analysis was performed using Kaplan-Meier method. |
| Secondary | Overall Survival (OS) | From date of randomization or date of start of treatment to date of death due to any cause or date of censoring, whichever occurred first (maximum duration of up to 33 months) | Overall survival was defined as the time (in months) from the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. |
| Secondary | Duration of Response (DOR) | From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum duration of up to 33 months) | DOR:time from first documentation of OR (confirmed CR or PR) to first documentation of PD/death due to any cause/data censoring date,whichever occurred first. As per RECIST v1.0, CR:disappearance of all target(T) and non-target (Non-T) lesions sustained for =\>4 weeks. Any pathological lymph nodes(T or non-T) reduced in short axis to \<10mm. PR:\>=30% decrease in sum of diameters(SOD) of T lesions, taking as reference baseline SOD. PD for T lesions:at least a 20% increase in sum of diameters of T lesions, taking as reference smallest sum on study treatment, with absolute increase of \>=5 mm,or appearance of \>=1 new lesions.PD for Non-T lesions:unequivocal progression of pre-existing lesions/increase in overall tumor burden leading to discontinuation of therapy/appearance of new unequivocal malignant lesion.Data was censored on date of last adequate tumor assessment for participants without an event,who started new anti-cancer treatment prior to assessment,who missed \>=2 tumor assessments. |
| Secondary | Time to Response (TTR) | From the date of randomization or date of start of treatment to the first documentation of objective response (CR or PR) or data censoring date, whichever occurred first (maximum duration of up to 33 months) | TTR as assessed by investigator according to RECIST v1.0, was defined as the time (in months) from date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. |
| Secondary | Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Reactions Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.0 | Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately) | Adverse drug reaction (ADR) was any untoward medical occurrence attributed to study drug in participants who received study drug. As per NCI-CTCAE v4.0, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or non-invasive 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 study drug. Treatment-emergent ADRs are between first dose of study drug and up to 30 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. Number of participants with any Grade 3 or 4 treatment-emergent ADR were reported in this outcome measure. |
| Secondary | Number of Participants With Serious Adverse Reactions | Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately) | A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying) ; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly, important medical event. |
| Secondary | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology) | Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately) | Hematology per NCI-CTCAE included, Lymphocyte count decreased-(G1:\<0.8, G2:\<0.8-0.5, G3:\<0.5-0.2, G4:\<0.2\[\*10\^9/L\]); Lymphocyte count increased-(G2:\>4-20, G3:\>20\[\*10\^9/L\]); Neutrophil count decreased-(G1:\<1.5, G2:\<1.5-1.0, G3:\<1.0-0.5, G4:\<0.5\[\*10\^9/L\]); Activated partial thromboplastin time prolonged (seconds)-(G1:\>1.5\*upper limit normal (ULN), G2:\>1.5-2.5\*ULN, G3:\>2.5\*ULN); Platelet count decreased-(G1:\<75.0, G2:\<75.0-50.0, G3:\<50.0-25.0, G4:\<25.0\[\*10\^9/L\]); Fibrinogen decreased-(G1:\<1.0-0.75\*lower limit normal (LLN), G2:\<0.75-0.5\*LLN, G3:\<0.5-0.25\*LLN G4:\<0.25\*LLN); Anemia-(G1:\<LLN-100, G2:\<100-80, G3:\<80 \[g/L\], G4:Life-threatening, G5:death); Hemoglobin increased-(G1:\>0-2 g/dL above ULN, G2:\>2-4 g/dL above ULN, G3:\>4 g/dL above ULN); Prothrombin time (INR) increased-(G1:\>1-1.5, G2:\>1.5-2.5, G3:\>2.5\[\*ULN\]); WBC decreased-(G1:\<3.0\*10\^9/L, G2:\<3.0-2.0\*10\^9/L, G3:\<2.0-1.0\*10\^9/L, G4:\<1.0\*10\^9/L); WBC increased-(G3:\>100,000/mm3, G4:Clinical manifestations of increase in WBC, G5:death). |
| Secondary | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries) | Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately) | Albumin(G1:\<30,G2:\<30-20,G3:\<20\[g/L\], G4:life-threatening, G5:death);Alkaline phosphatase(G1:\>2.5,G2:\>2.5-5.0,G3:\>5.0-20.0, G4:\>20.0\[\*ULN\]);Creatine kinase(G1:\>2.5,G2:\>2.5-5,G3:\>5-10,G4:\>10\[\*ULN\]);Creatinine(CT) clearance(G1:\<LLN-60,G2:59-30,G3:29-15,G3:\<15\[ml/min/1.73m\^2\], G5:death);CT (G1:\>1.5,G2:\>1.5-3.0,G3:\>3.0-6.0,G4:\>6.0\[\*ULN\]);Hypomagnesemia(G1:\<0.5,G2:\<0.5-0.4,G3:\<0.4-0.3,G4:\<0.3\[mmol/L\],G5:death);Hypermagnesemia(G1:\>1.23,G3:\>1.23-3.30, G4:\>3.30\[mmol/L\],G5:death);Hypophosphatemia(G1:\<0.8,G2:\<0.8-0.6,G3:\<0.6-0.3,G4:\<0.3\[mmol/L\], G5:death);Hypokalemia(G1:\<3.0,G2:\<3.0,G3:\<3.0-2.5,G4:\<2.5\[mmol/L\],G5:death);Hyperkalemia(G1:\>5.5,G2:\>5.5-6.0,G3:\>6.0-7.0, G4:\>7.0\[mmol/L\],G5:death);AST(G1:\>3.0,G2:\>3.0-5.0,G3:\>5.0-20.0,G4:\>20.0\[\*ULN\]); ALT(G1:\>3.0,G2:\>3.0-5.0,G3:\>5.0-20.0,G4:\>20.0\[\*ULN\]);Hyponatremia(G1:\<130,G3:\<130-120,G4:\<120\[mmol/L\],G5:death);Hypernatremia(G1:150,G2:\>150-155,G3:\>155-160,G4:\>160\[mmol/L\],G5:death);High blood bilirubin (G1:\>1.5,G2:\>1.5-3.0,G3:\>3.0-10.0,G4:\>10.0\[\*ULN\]). |
| Secondary | Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure) | Baseline up to 30 days after last dose of study drug (up to maximum of 33 months) | Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP). |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Objective Response (OR) | From date of randomization or date of start of treatment until date of first documentation of PD or death due to any cause, whichever occurred first (maximum duration of up to 33 months) | The full analysis set included all randomized participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | From date of randomization or date of start of treatment until date of first documentation of PD or date of death due to any cause or date of data censoring, whichever occurred first (maximum duration of up to 33 months) | The full analysis set included all randomized participants who received at least one dose of study drug. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From date of randomization or date of start of treatment to date of death due to any cause or date of censoring, whichever occurred first (maximum duration of up to 33 months) | The full analysis set included all randomized participants who received at least one dose of study drug. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum duration of up to 33 months) | The full analysis set included all randomized participants who received at least one dose of study drug. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Time to Response (TTR) | From the date of randomization or date of start of treatment to the first documentation of objective response (CR or PR) or data censoring date, whichever occurred first (maximum duration of up to 33 months) | The full analysis set included all randomized participants who received at least one dose of study drug. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Reactions Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.0 | Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately) | Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Reactions | Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately) | Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology) | Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately) | Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries) | Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately) | Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure) | Baseline up to 30 days after last dose of study drug (up to maximum of 33 months) | Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group1,066
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Objective Response (OR) | Binimetinib 45 mg BRAF | 4.9 | 95% Confidence Interval 0.6 to 16.5 | percentage of participants | |
| Percentage of Participants With Objective Response (OR) | Binimetinib 45 mg NRAS | 14.5 | 95% Confidence Interval 8.7 to 22.2 | percentage of participants | |
| Percentage of Participants With Objective Response (OR) | Binimetinib 60 mg BRAF | 12.0 | 95% Confidence Interval 2.5 to 31.2 | percentage of participants | |
| Progression-Free Survival (PFS) | Binimetinib 45 mg BRAF | 3.5 | 95% Confidence Interval 1.9 to 3.8 | months | |
| Progression-Free Survival (PFS) | Binimetinib 45 mg NRAS | 3.6 | 95% Confidence Interval 2.6 to 3.8 | months | |
| Progression-Free Survival (PFS) | Binimetinib 60 mg BRAF | 1.8 | 95% Confidence Interval 1.5 to 3.7 | months | |
| Overall Survival (OS) | Binimetinib 45 mg BRAF | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Binimetinib 45 mg NRAS | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Binimetinib 60 mg BRAF | 16.6 | 95% Confidence Interval 4.9 to NA | months | |
| Duration of Response (DOR) | Binimetinib 45 mg BRAF | 3.6 | 95% Confidence Interval 3.6 to 3.7 | months |
1 to 10 of 1,066Source ClinicalTrials.gov
See all 1,066 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Binimetinib 45 mg BRAF | 41 | |
| Overall Study | STARTED | Binimetinib 45 mg NRAS | 117 | |
| Overall Study | STARTED | Binimetinib 60 mg BRAF | 25 | |
| Overall Study | COMPLETED | Binimetinib 45 mg BRAF | 0 | |
| Overall Study | COMPLETED | Binimetinib 45 mg NRAS | 0 | |
| Overall Study | COMPLETED | Binimetinib 60 mg BRAF | 0 | |
| Overall Study | NOT COMPLETED | Binimetinib 45 mg BRAF | 41 | |
| Overall Study | NOT COMPLETED | Binimetinib 45 mg NRAS | 117 | |
| Overall Study | NOT COMPLETED | Binimetinib 60 mg BRAF | 25 |
Source ClinicalTrials.gov
Adverse events1,554
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Binimetinib 45 mg BRAF | 4 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | Binimetinib 45 mg NRAS | 17 | 117 | |
| other | Anaemia | Blood and lymphatic system disorders | Binimetinib 60 mg BRAF | 3 | 25 | |
| other | Chorioretinopathy | Eye disorders | Binimetinib 45 mg BRAF | 0 | 41 | |
| other | Chorioretinopathy | Eye disorders | Binimetinib 45 mg NRAS | 16 | 117 | |
| other | Chorioretinopathy | Eye disorders | Binimetinib 60 mg BRAF | 1 | 25 | |
| other | Diarrhoea | Gastrointestinal disorders | Binimetinib 45 mg BRAF | 18 | 41 | |
| other | Diarrhoea | Gastrointestinal disorders | Binimetinib 45 mg NRAS | 57 | 117 | |
| other | Diarrhoea | Gastrointestinal disorders | Binimetinib 60 mg BRAF | 13 | 25 | |
| other | Nausea | Gastrointestinal disorders | Binimetinib 45 mg BRAF | 10 | 41 |
1 to 10 of 1,554Source ClinicalTrials.gov
See all 1,554 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Binimetinib 45 mg BRAF | 5 | 41 |
| Total, all-cause mortality | Binimetinib 45 mg NRAS | 51 | 117 |
| Total, all-cause mortality | Binimetinib 60 mg BRAF | 10 | 25 |
| Total, other adverse events | Binimetinib 45 mg BRAF | 40 | 41 |
| Total, other adverse events | Binimetinib 45 mg NRAS | 117 | 117 |
| Total, other adverse events | Binimetinib 60 mg BRAF | 25 | 25 |
| Total, serious adverse events | Binimetinib 45 mg BRAF | 11 | 41 |
| Total, serious adverse events | Binimetinib 45 mg NRAS | 39 | 117 |
| Total, serious adverse events | Binimetinib 60 mg BRAF | 9 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23414587 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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