Trial Outcomes & Findings for Phase II Trial of SOM230 in Patients With Unresectable Hepatocellular Carcinoma (NCT NCT01639352)
NCT ID: NCT01639352
Last Updated: 2017-07-12
Results Overview
The disease-control rate (DCR) is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response or stable disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan, and that is maintained for at least 8 weeks. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
At least 2 cycles, about 8 weeks
Results posted on
2017-07-12
Participant Flow
Participant milestones
| Measure |
SOM230
60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial of SOM230 in Patients With Unresectable Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
SOM230
n=20 Participants
60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Prior Therapies
No prior therapy
|
2 Participants
n=5 Participants
|
|
Prior Therapies
Transarterial chemoembolization (TACE)
|
12 Participants
n=5 Participants
|
|
Prior Therapies
Chemotherapy
|
2 Participants
n=5 Participants
|
|
Prior Therapies
Ablation
|
6 Participants
n=5 Participants
|
|
Prior Therapies
Ytrium 90
|
2 Participants
n=5 Participants
|
|
Prior Therapies
Cryoablation
|
1 Participants
n=5 Participants
|
|
Prior Therapies
Sorafenib
|
14 Participants
n=5 Participants
|
|
BCLC Staging
BCLC Stage 0
|
0 Participants
n=5 Participants
|
|
BCLC Staging
BCLC Stage A
|
0 Participants
n=5 Participants
|
|
BCLC Staging
BCLC Stage B
|
5 Participants
n=5 Participants
|
|
BCLC Staging
BCLC Stage C
|
15 Participants
n=5 Participants
|
|
BCLC Staging
BCLC Stage D
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At least 2 cycles, about 8 weeksThe disease-control rate (DCR) is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response or stable disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan, and that is maintained for at least 8 weeks. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
SOM230
n=20 Participants
60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
|
|---|---|
|
Disease Control Rate (DCR)
Stable Disease (SD)
|
9 Participants
|
|
Disease Control Rate (DCR)
Complete Response (CR)
|
0 Participants
|
|
Disease Control Rate (DCR)
Partial Response (PR)
|
0 Participants
|
SECONDARY outcome
Timeframe: From Enrollment Until Study Completion, Approximately 3 YearsRate of Progression-Free Survival (PFS). PFS will be measured from the date of enrollment to the earliest date of documented disease progression or death from any cause, whichever is earlier. Progression is defined according to RECIST v 1.1 criteria as an at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who remain alive without progression, follow up time will be censored at the date of last disease assessment.
Outcome measures
| Measure |
SOM230
n=20 Participants
60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
|
|---|---|
|
Rate of Progression-Free Survival (PFS):
|
3 months
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: From Enrollment Until Study Completion, Approximately 3 YearsRate of Overall Survival (OS) in participants receiving protocol therapy. OS will be measured from the date of enrollment to the date of death or last contact.
Outcome measures
| Measure |
SOM230
n=20 Participants
60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
|
|---|---|
|
Rate of Overall Survival (OS)
|
9 months
Interval 4.0 to
Seven patients were alive at the discontinuation of the study.
|
SECONDARY outcome
Timeframe: Up to 2 YearsProportion of patients achieving Complete Response and Partial Response (CR+PR) to protocol therapy per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT Scan. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
SOM230
n=20 Participants
60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
|
|---|---|
|
Overall Response Rate (ORR)
Complete Response (CR)
|
0 Participants
|
|
Overall Response Rate (ORR)
Partial Response (PR)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 YearsPopulation: No participants achieved complete response (CR) or partial response (PR) to protocol therapy.
Duration of Overall Response in participants achieving complete response (CR) or partial response (PR) to SOM230 treatment. The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Overall response is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 YearsNumber of patients experiencing adverse events and/or toxicities while receiving protocol therapy.
Outcome measures
| Measure |
SOM230
n=20 Participants
60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
|
|---|---|
|
Toxicity Profile of Protocol Therapy
|
20 Participants
|
Adverse Events
SOM230
Serious events: 5 serious events
Other events: 20 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
SOM230
n=20 participants at risk
60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Nervous system disorders
Encephalopathy
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Infections and infestations
Infection with unknown ANC
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Infections and infestations
Infections and infestations - Other
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Obstruction, GI
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
Other adverse events
| Measure |
SOM230
n=20 participants at risk
60mg of SOM230 via injection intramuscularly every 28 days
SOM230: Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
15.0%
3/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
3/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Acidosis
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Number of events 5 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
15.0%
3/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
3/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20 • Number of events 6 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
5.0%
1/20 • Number of events 4 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
5.0%
1/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
20.0%
4/20 • Number of events 5 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Investigations
Blood bilirubin increased
|
10.0%
2/20 • Number of events 10 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
10.0%
2/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Investigations
Cholesterol high
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Nervous system disorders
Confusion
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Creatinine increased
|
5.0%
1/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Investigations
Creatinine increased
|
10.0%
2/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Dehydration
|
5.0%
1/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
35.0%
7/20 • Number of events 7 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
10.0%
2/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
General disorders
Edema limbs
|
20.0%
4/20 • Number of events 4 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Blood and lymphatic system disorders
Edema: limb
|
25.0%
5/20 • Number of events 5 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
General disorders
Fatigue
|
35.0%
7/20 • Number of events 8 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
20.0%
4/20 • Number of events 4 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
General disorders
Flu like symptoms
|
10.0%
2/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
General disorders
Hemorrhage, GI
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Hepatobiliary disorders
Hepatic failure
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Endocrine disorders
Hot flashes/flushes
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
15.0%
3/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.0%
7/20 • Number of events 16 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Endocrine disorders
Hyperthyroidism
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Hypoglycemia
|
15.0%
3/20 • Number of events 3 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Infections and infestations
Infection with unknown ANC
|
10.0%
2/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Nervous system disorders
Mood alteration
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
General disorders
Multi-organ failure
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Number of events 5 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
General disorders
Pain
|
30.0%
6/20 • Number of events 10 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Blood and lymphatic system disorders
Platelets
|
10.0%
2/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Eye disorders
Scleral disorder
|
10.0%
2/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
10.0%
2/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Renal and urinary disorders
Urinary Retention
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Infections and infestations
Urinary Tract Infection
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Cardiac disorders
Ventricular Arrythmia
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 2 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Investigations
Weight Gain
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Investigations
Weight Loss
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • The period of adverse event collection will be from the day of the 1st treatment until at least 4 weeks after study discontinuation, up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place