Trial Outcomes & Findings for MK-2206 and AZD6244 in Patients With Advanced Colorectal Carcinoma (NCT NCT01333475)
NCT ID: NCT01333475
Last Updated: 2015-09-30
Results Overview
A predetermined target inhibition reduction of 70% of both pERK and pAKT was deemed significant, thus tumor biopsies were performed at C1D1 or C1D22 post administration and evaluated using quantitative chemiluminescence immunoassay to measure pERK and pAKT levels in human tissue.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
C1D1 and C1D22 post administration of the combination of AZD6244 hydrogen sulfate and MK-2206
Results posted on
2015-09-30
Participant Flow
Because dual target evaluation of \>70% was not observed in the tumor biopsies from any of the participants evaluated, no participants were enrolled to Cohort C to evaluate target recovery. TAC1 and TAC1A -Since all patients received both drugs, each of the TACs (Treatment Assignment Code) reflect the dose level.
Participant milestones
| Measure |
TAC1
Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
TAC1A
Cycle = 28 days:MK-2206:135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
TAC1
Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
TAC1A
Cycle = 28 days:MK-2206:135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
|---|---|---|
|
Overall Study
pt withdrew-need emergent radiation trmt
|
1
|
0
|
|
Overall Study
Toxicity
|
1
|
3
|
Baseline Characteristics
MK-2206 and AZD6244 in Patients With Advanced Colorectal Carcinoma
Baseline characteristics by cohort
| Measure |
TAC1
n=12 Participants
Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
TAC1A
n=9 Participants
Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: C1D1 and C1D22 post administration of the combination of AZD6244 hydrogen sulfate and MK-2206A predetermined target inhibition reduction of 70% of both pERK and pAKT was deemed significant, thus tumor biopsies were performed at C1D1 or C1D22 post administration and evaluated using quantitative chemiluminescence immunoassay to measure pERK and pAKT levels in human tissue.
Outcome measures
| Measure |
TAC1
n=10 Participants
Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
TAC1A
n=6 Participants
Cycle = 28 days:MK-2206: 135mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
|---|---|---|
|
pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer
pAKT Baseline C1D1
|
4.86 pg/ µg of protein
Interval 1.89 to 7.41
|
0 pg/ µg of protein
Interval 0.0 to 0.0
|
|
pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer
pAKT post administration C1D1
|
2.20 pg/ µg of protein
Interval 1.44 to 3.44
|
NA pg/ µg of protein
N/A values identify levels that were not investigated - no participants were enrolled.
|
|
pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer
pAKT Baseline C1D22
|
NA pg/ µg of protein
N/A values identify levels that were not investigated - no participants were enrolled.
|
4.22 pg/ µg of protein
Interval 1.56 to 7.64
|
|
pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer
pAKT Post administration C1D22
|
NA pg/ µg of protein
N/A values identify levels that were not investigated - no participants were enrolled.
|
2.91 pg/ µg of protein
Interval 1.27 to 7.3
|
|
pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer
pERK Baseline C1D1
|
5.06 pg/ µg of protein
Interval 1.56 to 12.26
|
NA pg/ µg of protein
N/A values identify levels that were not investigated - no participants were enrolled.
|
|
pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer
pERK post administration C1D1
|
2.77 pg/ µg of protein
Interval 1.56 to 4.93
|
NA pg/ µg of protein
N/A values identify levels that were not investigated - no participants were enrolled.
|
|
pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer
pERK Baseline C1D22
|
NA pg/ µg of protein
N/A values identify levels that were not investigated - no participants were enrolled.
|
3.97 pg/ µg of protein
Interval 1.56 to 7.19
|
|
pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer
pERK Post administration C1D22
|
NA pg/ µg of protein
N/A values identify levels that were not investigated - no participants were enrolled.
|
3.5 pg/ µg of protein
Interval 1.56 to 6.82
|
SECONDARY outcome
Timeframe: 29 months, 23 daysHere is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
TAC1
n=12 Participants
Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
TAC1A
n=9 Participants
Cycle = 28 days:MK-2206: 135mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
12 participants
|
8 participants
|
Adverse Events
TAC1
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
TAC1A
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAC1
n=12 participants at risk
Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
TAC1A
n=9 participants at risk
Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Biliary tract infection
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Blood bilirubin increased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/12
|
33.3%
3/9 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
TAC1
n=12 participants at risk
Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
TAC1A
n=9 participants at risk
Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD
MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
2/12 • Number of events 2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
2/12 • Number of events 2
|
33.3%
3/9 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
58.3%
7/12 • Number of events 16
|
66.7%
6/9 • Number of events 11
|
|
Investigations
Alkaline phosphatase increased
|
58.3%
7/12 • Number of events 16
|
66.7%
6/9 • Number of events 9
|
|
Immune system disorders
Allergic rhinitis
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
6/12 • Number of events 11
|
44.4%
4/9 • Number of events 11
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
3/12 • Number of events 5
|
33.3%
3/9 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Aspartate aminotransferase increased
|
83.3%
10/12 • Number of events 27
|
55.6%
5/9 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 2
|
11.1%
1/9 • Number of events 2
|
|
Gastrointestinal disorders
Bloating
|
16.7%
2/12 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
41.7%
5/12 • Number of events 9
|
11.1%
1/9 • Number of events 1
|
|
Eye disorders
Blurred vision
|
8.3%
1/12 • Number of events 3
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Investigations
CPK increased
|
33.3%
4/12 • Number of events 6
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/12
|
22.2%
2/9 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
|
22.2%
2/9 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Creatinine increased
|
16.7%
2/12 • Number of events 5
|
0.00%
0/9
|
|
Renal and urinary disorders
Cystitis noninfective
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
2/12 • Number of events 2
|
11.1%
1/9 • Number of events 3
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
4/12 • Number of events 9
|
44.4%
4/9 • Number of events 11
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2
|
11.1%
1/9 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12
|
33.3%
3/9 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 2
|
22.2%
2/9 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
2/12 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Edema face
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Edema limbs
|
25.0%
3/12 • Number of events 3
|
11.1%
1/9 • Number of events 3
|
|
General disorders
Edema trunk
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Fatigue
|
58.3%
7/12 • Number of events 9
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1
|
22.2%
2/9 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.3%
1/12 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Eye disorders
Floaters
|
0.00%
0/12
|
11.1%
1/9 • Number of events 2
|
|
General disorders
Flu like symptoms
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 2
|
22.2%
2/9 • Number of events 3
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
41.7%
5/12 • Number of events 10
|
66.7%
6/9 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
2/12 • Number of events 15
|
33.3%
3/9 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
2/12 • Number of events 5
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.3%
1/12 • Number of events 1
|
11.1%
1/9 • Number of events 2
|
|
Vascular disorders
Hypertension
|
83.3%
10/12 • Number of events 39
|
77.8%
7/9 • Number of events 22
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
91.7%
11/12 • Number of events 24
|
66.7%
6/9 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
2/12 • Number of events 3
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
41.7%
5/12 • Number of events 11
|
22.2%
2/9 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
58.3%
7/12 • Number of events 9
|
44.4%
4/9 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/12
|
11.1%
1/9 • Number of events 2
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 2
|
0.00%
0/9
|
|
Investigations
Lymphocyte count decreased
|
58.3%
7/12 • Number of events 11
|
66.7%
6/9 • Number of events 11
|
|
Investigations
Lymphocyte count increased
|
8.3%
1/12 • Number of events 3
|
0.00%
0/9
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
2/12 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12
|
11.1%
1/9 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
58.3%
7/12 • Number of events 13
|
55.6%
5/9 • Number of events 14
|
|
General disorders
Non-cardiac chest pain
|
16.7%
2/12 • Number of events 2
|
0.00%
0/9
|
|
General disorders
Pain
|
16.7%
2/12 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
16.7%
2/12 • Number of events 2
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Platelet count decreased
|
25.0%
3/12 • Number of events 4
|
33.3%
3/9 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
1/12 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/12
|
22.2%
2/9 • Number of events 5
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/12
|
11.1%
1/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
3/12 • Number of events 3
|
66.7%
6/9 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
2/12 • Number of events 3
|
33.3%
3/9 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
33.3%
4/12 • Number of events 4
|
0.00%
0/9
|
|
Cardiac disorders
Sinus bradycardia
|
25.0%
3/12 • Number of events 3
|
11.1%
1/9 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Skin infection
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1
|
22.2%
2/9 • Number of events 3
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
5/12 • Number of events 10
|
44.4%
4/9 • Number of events 11
|
|
Eye disorders
Watering eyes
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Weight loss
|
0.00%
0/12
|
11.1%
1/9 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Investigations
White blood cell decreased
|
8.3%
1/12 • Number of events 1
|
22.2%
2/9 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place