Trial Outcomes & Findings for Selumetinib in Cancers With BRAF Mutations (NCT NCT00888134)
NCT ID: NCT00888134
Last Updated: 2016-01-15
Results Overview
Percentage of participants achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans (which are done every 6 weeks).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
4 years
Results posted on
2016-01-15
Participant Flow
Participants 'complete' the treatment period if they ended their treatment for disease progression, unacceptable toxicity, withdrawal of consent, or intercurrent illness. Those participants who completed treatment then enter a follow-up period when they are followed until death or lost-to-follow-up.
Participant milestones
| Measure |
Treatment (Selumetinib)
Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
|
|---|---|
|
Treatment With Study Drug
STARTED
|
28
|
|
Treatment With Study Drug
COMPLETED
|
27
|
|
Treatment With Study Drug
NOT COMPLETED
|
1
|
|
Follow-up
STARTED
|
27
|
|
Follow-up
COMPLETED
|
26
|
|
Follow-up
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Selumetinib)
Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
|
|---|---|
|
Treatment With Study Drug
Withdrawal by Subject
|
1
|
|
Follow-up
being followed for long-term survival
|
1
|
Baseline Characteristics
Selumetinib in Cancers With BRAF Mutations
Baseline characteristics by cohort
| Measure |
Treatment (Selumetinib)
n=28 Participants
Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Type of cancer
Non small-cell lung cancer
|
14 participants
n=5 Participants
|
|
Type of cancer
Colon cancer
|
10 participants
n=5 Participants
|
|
Type of cancer
Other cancer
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPercentage of participants achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans (which are done every 6 weeks).
Outcome measures
| Measure |
Treatment (Selumetinib)
n=28 Participants
Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
|
|---|---|
|
Objective Response Rate in Patients With Cancers Other Than Melanoma
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Samples and data were not collected for this outcome.
Correlation between response to AZD6244 and mutational analysis of AKT pathway (an intracellular signaling pathway important in regulating the cell cycle)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsPercentage of participants with either colon cancer or non-small cell lung cancer achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans.
Outcome measures
| Measure |
Treatment (Selumetinib)
n=24 Participants
Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
|
|---|---|
|
Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 4 monthsReported as percentage of participants alive and progression free at 4-months. Will be estimated using Kaplan-Meier survival curves. Confidence intervals will be calculated and reported.
Outcome measures
| Measure |
Treatment (Selumetinib)
n=28 Participants
Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
|
|---|---|
|
Progression-free Survival
|
21.4 percentage of participants
Interval 8.7 to 37.8
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Samples and data were not collected for this outcome.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Selumetinib)
Serious events: 17 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Selumetinib)
n=28 participants at risk
Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
|
|---|---|
|
Endocrine disorders
hypothyroidism
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
SGPT
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
Fistula
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Infections and infestations
pulmonary / URT infection
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
malignant ascites
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
ileus
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
SGOT
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Psychiatric disorders
confusion
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
General disorders
fatigue
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Psychiatric disorders
mental status changes
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
fatal progressive disease
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Eye disorders
increased intraocular pressure
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Eye disorders
blurry vision
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Skin and subcutaneous tissue disorders
skin infection
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Eye disorders
retinopathy
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Nervous system disorders
dizziness
|
3.6%
1/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
Other adverse events
| Measure |
Treatment (Selumetinib)
n=28 participants at risk
Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Selumetinib: Given PO
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Ear and labyrinth disorders
tinnitus
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Blood and lymphatic system disorders
hemoglobin - low
|
67.9%
19/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Blood and lymphatic system disorders
leukocytes
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Blood and lymphatic system disorders
lymphopenia
|
28.6%
8/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Blood and lymphatic system disorders
platelets
|
21.4%
6/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Cardiac disorders
hypertension
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Investigations
INR
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Investigations
PTT
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
General disorders
fatigue
|
67.9%
19/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
General disorders
fever (without neutropenia)
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Psychiatric disorders
insomnia
|
17.9%
5/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Skin and subcutaneous tissue disorders
nail changes
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
14.3%
4/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
21.4%
6/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Skin and subcutaneous tissue disorders
rash: acneiform
|
67.9%
19/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Skin and subcutaneous tissue disorders
rash: erythema multiforme
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Skin and subcutaneous tissue disorders
skin - other
|
14.3%
4/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
anorexia
|
17.9%
5/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
constipation
|
28.6%
8/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
diarrhea
|
50.0%
14/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
dry mouth
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
fistula
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
mucositis
|
14.3%
4/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
nausea
|
53.6%
15/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
taste disturbance
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
vomiting
|
46.4%
13/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
hemorrhage - anus
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Respiratory, thoracic and mediastinal disorders
hemorrhage - nose
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Blood and lymphatic system disorders
edema - head and neck
|
17.9%
5/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Blood and lymphatic system disorders
edema - limb
|
50.0%
14/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Blood and lymphatic system disorders
edema - trunk
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
57.1%
16/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
alkaline phosphatase
|
60.7%
17/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
SGPT
|
35.7%
10/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
SGOT
|
75.0%
21/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
bicarbonate
|
14.3%
4/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
bilirubin
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
25.0%
7/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hypercholesterolemia
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
creatinine
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
71.4%
20/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
28.6%
8/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
21.4%
6/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hypokalemia
|
25.0%
7/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
hyponatremia
|
28.6%
8/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Nervous system disorders
dizziness
|
21.4%
6/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Psychiatric disorders
depression
|
14.3%
4/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Nervous system disorders
neuropathy - sensory
|
25.0%
7/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Eye disorders
tearing
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
abdominal pain
|
28.6%
8/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
25.0%
7/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Musculoskeletal and connective tissue disorders
extremity - limb pain
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Nervous system disorders
headache
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
7.1%
2/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
46.4%
13/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
35.7%
10/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Respiratory, thoracic and mediastinal disorders
voice changes/ dysarthria
|
14.3%
4/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Infections and infestations
infection
|
17.9%
5/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Skin and subcutaneous tissue disorders
other
|
14.3%
4/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Gastrointestinal disorders
other
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Metabolism and nutrition disorders
other
|
17.9%
5/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Eye disorders
other
|
10.7%
3/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
|
Respiratory, thoracic and mediastinal disorders
other
|
14.3%
4/28 • Adverse events experienced by participants will be followed for 30 days after participant stops treatment. (if ongoing beyond 30 days, they were contacted by the study team until the event resolved)
Participants were seen every 3 weeks during study treatment for physical exam, vital signs and laboratory assessments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60