Trial Outcomes & Findings for BKM120 in Metastatic Castration-resistant Prostate Cancer (NCT NCT01385293)
NCT ID: NCT01385293
Last Updated: 2017-05-19
Results Overview
Time in months from the start of study treatment to the date of first progression or death due to any cause. Progression was determined either radiographically using a composite of the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 2 (PCWG2) criteria or clinically as judged from a skeletal-related event, need for change in therapy, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Response and progression are evaluated using a combination of Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
5 years
Results posted on
2017-05-19
Participant Flow
Participant milestones
| Measure |
BKM 120
BKM120 at 100mg orally daily
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BKM120 in Metastatic Castration-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
BKM 120
n=30 Participants
BKM120 at 100mg orally daily
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 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
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Intent to treat
Time in months from the start of study treatment to the date of first progression or death due to any cause. Progression was determined either radiographically using a composite of the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 2 (PCWG2) criteria or clinically as judged from a skeletal-related event, need for change in therapy, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Response and progression are evaluated using a combination of Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
BKM 120
n=30 Participants
BKM120 at 100mg orally daily
|
|---|---|
|
Progression Free Survival (PFS) Prostate Cancer Working Group 2 (PCWG2) Criteria or Based on the Onset of a Skeletal Related Event.
|
1.9 months
Interval 1.7 to 3.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Intent to treat
The number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Response and progression is evaluated using a combination of the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) and the guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
BKM 120
n=30 Participants
BKM120 at 100mg orally daily
|
|---|---|
|
Radiologic Response
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 28 days post last study drug dose. This is the follow-up safety visit.Population: Intent to treat
Number of patients experiencing grade 3-5 adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
BKM 120
n=30 Participants
BKM120 at 100mg orally daily
|
|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
16 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Intent to treat
The number of patients with a 30% and 50% decrease in PSA from baseline.
Outcome measures
| Measure |
BKM 120
n=30 Participants
BKM120 at 100mg orally daily
|
|---|---|
|
Prostate Specific Antigen (PSA) Response
30% Decrease
|
1 participants
|
|
Prostate Specific Antigen (PSA) Response
50% Decrease
|
0 participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Intent to treat
Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Outcome measures
| Measure |
BKM 120
n=30 Participants
BKM120 at 100mg orally daily
|
|---|---|
|
Overall Survival of Participants.
|
10.6 months
Interval 6.5 to 14.6
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 13 patients had measured CTC levels above 5 at baseline
The number of patients with a baseline CTC level of at least 5 who achieved a CTC level of less than 5 during the study.
Outcome measures
| Measure |
BKM 120
n=13 Participants
BKM120 at 100mg orally daily
|
|---|---|
|
Change in Circulating Tumor Cell (CTC) Levels From Baseline
|
1 participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Only those patients that experienced a new lesion per this definition are included.
Time in days from the start of study treatment to time of new metastatic disease. Time to new metastatic disease is, defined from the date of first study agent administration to the onset of a new evaluable site of disease as per PCWG2 and RECIST 1.1 guidelines, excluding the primary site and all sites documented at baseline will be assessed. Only those patients that experienced a new lesion per this definition are included.
Outcome measures
| Measure |
BKM 120
n=12 Participants
BKM120 at 100mg orally daily
|
|---|---|
|
Time to New Metastatic Disease From the Baseline Visit
|
55 days
Interval 38.0 to 108.0
|
Adverse Events
BKM 120
Serious events: 12 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BKM 120
n=30 participants at risk
BKM120 at 100mg orally daily
|
|---|---|
|
Cardiac disorders
Hypotension
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Cardiac disorders
Myocardial Infarction
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
General disorders
Death NOS
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Infections and infestations
Bronchial Infection
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Pain, worsening bone
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Seizure
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Psychiatric disorders
Confusion
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Acute Renal Failure
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Urethral obstruction
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
3/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
Other adverse events
| Measure |
BKM 120
n=30 participants at risk
BKM120 at 100mg orally daily
|
|---|---|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Lip pain (dry lips)
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Mucositis
|
10.0%
3/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
10/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Stomach pain
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Stomatitis/mouth ulcer
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
General disorders
Chills
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
General disorders
Edema face
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
General disorders
Edema limbs
|
13.3%
4/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
General disorders
Fatigue
|
43.3%
13/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
General disorders
Gait Unsteadiness/imbalance
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
General disorders
Generalized cold sensation
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
General disorders
Left shoulder pain
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
General disorders
Right rib pain
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Hepatobiliary disorders
Liver Dysfunction
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Infections and infestations
Flu virus
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Infections and infestations
Fungal infection, tongue
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Infections and infestations
Tooth Infection
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Injury, poisoning and procedural complications
Abrasions
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Injury, poisoning and procedural complications
Bruising
|
10.0%
3/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Injury, poisoning and procedural complications
Sunburn
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Investigations
Creatinine increased
|
13.3%
4/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Investigations
Investigation
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Investigations
Lipase increased
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Investigations
Neutrophil count decreased
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Investigations
Platelet count decreased
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Investigations
Serum amylase increased
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Investigations
Weight loss
|
10.0%
3/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Investigations
White blood cell decreased
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
10/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
5/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
4/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (spasmatic pain)
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
36.7%
11/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Pain, Bilateral rib/flank
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Pain, jaw
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Pain, mid back to ribs
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Pain, worsening bone
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Pain- mid spine, shoulder
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Pain- right femur
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Pain- right flank
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
Weakness (lower extremity)
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Musculoskeletal and connective tissue disorders
pain, bone
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Cognitive disturbance
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Concentration impairment
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Depressed level of consciousness
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
3/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Lethargy
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Memory Loss
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Neuropathy
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Paresthesia
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Paresthesia, left foot
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Nervous system disorders
Tremor
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Psychiatric disorders
Agitation
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Psychiatric disorders
Confusion
|
16.7%
5/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Psychiatric disorders
Depression
|
26.7%
8/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Psychiatric disorders
Personality change
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Psychiatric disorders
Psych disorder, other
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Acute renal failure
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Dysuria
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Hematuria
|
10.0%
3/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Urinary frequency
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Renal and urinary disorders
Urinary tract pain
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
3/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Brittle nails
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Dry skin, upper R leg
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
4/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Rash, macular
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Rash, other (facial)
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Rash- plaque like
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Sunburn
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Surgical and medical procedures
Tooth Extraction
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Vascular disorders
Hypertension
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
5/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Eye disorders
Cataract
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Eye disorders
Eye disorder, other
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Abdominal pain, right side
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Bloat
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
3/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Constipation
|
26.7%
8/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Diarrhea
|
36.7%
11/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
Epigastric pain
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
|
Gastrointestinal disorders
GI virus
|
3.3%
1/30 • Adverse events will be collected from the start of treatment through the end Up to 28 days post last study drug dose. This is the follow-up safety visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place