Trial Outcomes & Findings for A Phase I/Ib Study of MEK162, a MEK Inhibitor, in Combination With Carboplatin and Pemetrexed in Patients With Non-squamous Carcinoma of the Lung (NCT NCT02185690)
NCT ID: NCT02185690
Last Updated: 2025-08-21
Results Overview
To determine the recommended dose in milligrams per day of the combination of MEK162 with standard therapy pemetrexed and carboplatin as determined by toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
22 weeks
Results posted on
2025-08-21
Participant Flow
Participants were enrolled based on physician referral, 1st participant was enrolled on 07 March 2017 and last participant was enrolled on 05 December 2018
Out of 16 patients screened, 13 were enrolled who met the eligibility criteria
Participant milestones
| Measure |
Binimetinib Dose Level 1 (30mg BID)
Phase I, dose level 1 group:
The dose of MEK162 for dose level 1 group will be 30 mg BID.
Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3.
The rate of subject entry and escalation to the next dose level will depend upon assessment of the safety profile of patients entered at the previous dose level.
|
Binimetinib Dose Level 2 (45mg BID)
Phase I, dose level 2 group:
The dose of MEK162 for dose level 2 group will be 45 mg BID. Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3. The rate of subject entry and escalation to the next dose level will depend upon assessment of the safety profile of patients entered at the previous dose level.
|
|---|---|---|
|
Binimetinib Dose Level 1 (30mg BID)
STARTED
|
6
|
0
|
|
Binimetinib Dose Level 1 (30mg BID)
COMPLETED
|
6
|
0
|
|
Binimetinib Dose Level 1 (30mg BID)
NOT COMPLETED
|
0
|
0
|
|
Binimetinib Dose Level 2 (45mg BID)
STARTED
|
0
|
7
|
|
Binimetinib Dose Level 2 (45mg BID)
COMPLETED
|
0
|
7
|
|
Binimetinib Dose Level 2 (45mg BID)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Binimetinib Dose Level 1
n=6 Participants
Phase I, dose level 1 group:
The dose of MEK162 for dose level 1 group will be 30 mg BID.
Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3.
The rate of subject entry and escalation to the next dose level will depend upon assessment of the safety profile of patients entered at the previous dose level.
|
Binimetinib Dose Level 2
n=7 Participants
Phase I, dose level 2 group:
The dose of MEK162 for dose level 2 group will be 45 mg BID. Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3. The rate of subject entry and escalation to the next dose level will depend upon assessment of the safety profile of patients entered at the previous dose level.
|
Binimetinib Dose Level -1
Dose de-escalation group:
The dose of MEK162 for dose level -1 group will be 30 mg BID. Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3. The rate of subject entry and escalation or de-escalation will depend upon assessment of the safety profile of patients and dose limiting toxicities.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
|
0 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
0 Participants
|
9 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
0 Participants
|
4 Participants
n=13 Participants
|
|
Age, Continuous
|
63.166 years
n=6 Participants
|
56.428 years
n=7 Participants
|
—
|
59.538 years
n=13 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
—
|
6 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
—
|
7 Participants
n=13 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
6 participants
n=6 Participants
|
7 participants
n=7 Participants
|
—
|
13 participants
n=13 Participants
|
PRIMARY outcome
Timeframe: 22 weeksPopulation: One patient was not evaluable for DLT; therefore, an additional patient was enrolled at Dose Level 2. The outcome measure for the recommended does is 30 mg, both arms were combined in the analysis here in order to report 1 recommended single dose (30mg).
To determine the recommended dose in milligrams per day of the combination of MEK162 with standard therapy pemetrexed and carboplatin as determined by toxicity.
Outcome measures
| Measure |
Binimetinib Dose Level 1 & 2 (30mg BID & 45mg BID)
n=12 Participants
Phase I, dose level 1 \& 2 groups:
The dose of MEK162 for dose level 1 group will be 30 mg BID and for dose level 2 will be 45 mg BID.
Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
|
Binimetinib Dose Level 2 (45mg BID)
Dose level 2 arm had 7 patients but 1 was non-evaluable, so 6 patients only were evaluable.
2/6 patients achieved partial response for Dose Level 2 (33%)
|
|---|---|---|
|
Recommended Dose in Milligrams Per Day for Binimetinib.
|
30 mg
|
—
|
SECONDARY outcome
Timeframe: 22 weeksPopulation: Objective response rate (ORR) was defined as the percentage of patients who achieved a complete or partial response as the best overall response.
The size of tumors in centimeters before and after treatment. The measurements will be compared against the RECIST v1.1 criteria to ascertain response as defined in the protocol. Objective response rate (ORR) was defined as the percentage of patients who achieved a complete or partial response as the best overall response.
Outcome measures
| Measure |
Binimetinib Dose Level 1 & 2 (30mg BID & 45mg BID)
n=6 Participants
Phase I, dose level 1 \& 2 groups:
The dose of MEK162 for dose level 1 group will be 30 mg BID and for dose level 2 will be 45 mg BID.
Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
|
Binimetinib Dose Level 2 (45mg BID)
n=6 Participants
Dose level 2 arm had 7 patients but 1 was non-evaluable, so 6 patients only were evaluable.
2/6 patients achieved partial response for Dose Level 2 (33%)
|
|---|---|---|
|
Objective Response Rate (ORR) as Per RECIST v1.1.
|
4 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 22 weeksPopulation: Dose levels are combined as mutation information was obtained for the 12 patients in total and segregated in the results by these 2 groups only. Link to published results/ https://doi.org/10.1016/j.lungcan.2021.05.021
Exploratory analysis of mutation subtypes using next generation sequencing (NGS).
Outcome measures
| Measure |
Binimetinib Dose Level 1 & 2 (30mg BID & 45mg BID)
n=7 Participants
Phase I, dose level 1 \& 2 groups:
The dose of MEK162 for dose level 1 group will be 30 mg BID and for dose level 2 will be 45 mg BID.
Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
|
Binimetinib Dose Level 2 (45mg BID)
n=5 Participants
Dose level 2 arm had 7 patients but 1 was non-evaluable, so 6 patients only were evaluable.
2/6 patients achieved partial response for Dose Level 2 (33%)
|
|---|---|---|
|
Exploratory Analysis of Objective Response Rate, KRAS Mutation Sub-type.
|
62.5 percentage of participants
|
25 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksPopulation: Phase Ib. Evaluation of progression-free survival (PFS) rate for patients with and without KRAS mutation in tumor tissue. PFS is defined as the time from start of treatment to disease progression or death. PFS rate is calculated as a percentage of participants achieving a 6 months (26 weeks) period of progression free survival.
Evaluation progression-free survival rate (PFS) for patients with and without KRAS mutation in tumor tissue. PFS is defined as the time from start of treatment to disease progression or death. PFS rate is measured over 6 months period (26 weeks). PFS rate is calculated as a percentage of participants achieving a 6 months (26 weeks) period of progression free survival.
Outcome measures
| Measure |
Binimetinib Dose Level 1 & 2 (30mg BID & 45mg BID)
n=12 Participants
Phase I, dose level 1 \& 2 groups:
The dose of MEK162 for dose level 1 group will be 30 mg BID and for dose level 2 will be 45 mg BID.
Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
|
Binimetinib Dose Level 2 (45mg BID)
Dose level 2 arm had 7 patients but 1 was non-evaluable, so 6 patients only were evaluable.
2/6 patients achieved partial response for Dose Level 2 (33%)
|
|---|---|---|
|
Progression Free Survival Rate
|
38.5 percentage of participants
Interval 19.3 to 76.5
|
—
|
Adverse Events
Binimetinib Dose Level 1 (30mg BID)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Binimetinib Dose Level 2 (45mg BID)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Binimetinib Dose Level -1 (30mg BID)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Binimetinib Dose Level 1 (30mg BID)
n=6 participants at risk
Phase I, dose level 1 group:
The dose of MEK162 for dose level 1 group will be 30 mg BID.
Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3.
The rate of subject entry and escalation to the next dose level will depend upon assessment of the safety profile of patients entered at the previous dose level.
|
Binimetinib Dose Level 2 (45mg BID)
n=7 participants at risk
Phase I, dose level 2 group:
The dose of MEK162 for dose level 2 group will be 45 mg BID. Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3. The rate of subject entry and escalation to the next dose level will depend upon assessment of the safety profile of patients entered at the previous dose level.
|
Binimetinib Dose Level -1 (30mg BID)
Dose de-escalation group:
The dose of MEK162 for dose level -1 group will be 30 mg BID. Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3. The rate of subject entry and escalation or de-escalation will depend upon assessment of the safety profile of patients and dose limiting toxicities.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diverticulitis (grade 3)
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Immune system disorders
Febrile neutropenia (grade 3)
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infection (grade 2)
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Blood and lymphatic system disorders
Anemia (grade 3)
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Nervous system disorders
Confusion
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
0.00%
0/7 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral metastases
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
Other adverse events
| Measure |
Binimetinib Dose Level 1 (30mg BID)
n=6 participants at risk
Phase I, dose level 1 group:
The dose of MEK162 for dose level 1 group will be 30 mg BID.
Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3.
The rate of subject entry and escalation to the next dose level will depend upon assessment of the safety profile of patients entered at the previous dose level.
|
Binimetinib Dose Level 2 (45mg BID)
n=7 participants at risk
Phase I, dose level 2 group:
The dose of MEK162 for dose level 2 group will be 45 mg BID. Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3. The rate of subject entry and escalation to the next dose level will depend upon assessment of the safety profile of patients entered at the previous dose level.
|
Binimetinib Dose Level -1 (30mg BID)
Dose de-escalation group:
The dose of MEK162 for dose level -1 group will be 30 mg BID. Carboplatin will be given every 3 weeks. Pemetrexed will be given every 3 weeks.
Pemetrexed: 4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
Carboplatin: 4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
Minimum number of patients is 3. The rate of subject entry and escalation or de-escalation will depend upon assessment of the safety profile of patients and dose limiting toxicities.
|
|---|---|---|---|
|
Hepatobiliary disorders
ALT Increase
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Hepatobiliary disorders
AST Increase
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
0.00%
0/7 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Leg Weakness
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Hepatobiliary disorders
Bilirubin Increase
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • Number of events 4 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
28.6%
2/7 • Number of events 2 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Skin and subcutaneous tissue disorders
Dry skin/Rash
|
83.3%
5/6 • Number of events 5 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
71.4%
5/7 • Number of events 5 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Renal and urinary disorders
Dysuria/Hematuria
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
General disorders
Edema
|
50.0%
3/6 • Number of events 3 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
28.6%
2/7 • Number of events 2 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Cardiac disorders
Ejection Fraction Decrease
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Blood and lymphatic system disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
0.00%
0/7 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 4 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
28.6%
2/7 • Number of events 2 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
0.00%
0/7 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Gastrointestinal disorders
Mucositis (Oral, Nasal)
|
66.7%
4/6 • Number of events 4 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
57.1%
4/7 • Number of events 4 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 4 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
28.6%
2/7 • Number of events 2 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Immune system disorders
Neutrophil Count Decrease
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
28.6%
2/7 • Number of events 2 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Eye disorders
Ocular toxicity
|
83.3%
5/6 • Number of events 5 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
42.9%
3/7 • Number of events 3 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Cardiac disorders
Palpitations/Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Hepatobiliary disorders
Serum Amylase Increase
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Nervous system disorders
Vertigo
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Metabolism and nutrition disorders
Weight Gain
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
0.00%
0/7 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Metabolism and nutrition disorders
Weight Loss
|
0.00%
0/6 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
|
Immune system disorders
White Blood Cell Decrease
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
0.00%
0/7 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
—
0/0 • Adverse events (AE) were recorded for 22 weeks of treatment.
An adverse event is any untoward medical occurrence (including any abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational product) in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. Plus Expected Adverse Events and SAEs for MEK162 as per protocol. Systematic Assessment: Through standard questionnaire, regular PI assessment and regular lab testing.
|
Additional Information
Dr. Natasha Leighl, Sponsor-Investigator, Division of Medical Oncology
Princess Margaret Cancer Centre, University Health Network
Phone: 416-946-4645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place