Trial Outcomes & Findings for A Study to Assess the Safety and the Efficacy of the Combination of TH-302 and Sunitinib in Neuroendocrine Pancreatic Tumours (NCT NCT02402062)
NCT ID: NCT02402062
Last Updated: 2020-07-27
Results Overview
Objective response rate: percentage of patients in whom a complete response (CR) or a partial response (PR) is confirmed according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in relation to the total of the analyzed population. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
approximately 36 months
Results posted on
2020-07-27
Participant Flow
Meeting eligibility criteria: 17 patients that meet the eligibility criteria were finally included
Participant milestones
| Measure |
TH-302 + Sunitinib
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Safety and the Efficacy of the Combination of TH-302 and Sunitinib in Neuroendocrine Pancreatic Tumours
Baseline characteristics by cohort
| Measure |
TH-302 + Sunitinib
n=17 Participants
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Age, Continuous
|
60.78 Years
STANDARD_DEVIATION 10.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 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
Spain
|
17 Participants
n=5 Participants
|
|
ECOG PS
grade 0
|
11 Participants
n=5 Participants
|
|
ECOG PS
grade 1
|
6 Participants
n=5 Participants
|
|
Electrocardiogram (ECG)
|
17 Participants
n=5 Participants
|
|
Left ventricular ejection fraction (LVEF)
|
17 Participants
n=5 Participants
|
|
Abbreviated Charlson comorbidity index
index 2
|
11 Participants
n=5 Participants
|
|
Abbreviated Charlson comorbidity index
index 3
|
4 Participants
n=5 Participants
|
|
Abbreviated Charlson comorbidity index
index 4
|
2 Participants
n=5 Participants
|
|
Peripheral arterial disease
Yes
|
1 Participants
n=5 Participants
|
|
Peripheral arterial disease
No
|
16 Participants
n=5 Participants
|
|
Diabetes
Yes
|
5 Participants
n=5 Participants
|
|
Diabetes
No
|
12 Participants
n=5 Participants
|
|
Tumor histological grade
Grade I
|
2 Participants
n=5 Participants
|
|
Tumor histological grade
Grade II
|
15 Participants
n=5 Participants
|
|
Ki-67 index
>10%
|
8 Participants
n=5 Participants
|
|
Ki-67 index
>2%-5%
|
5 Participants
n=5 Participants
|
|
Ki-67 index
>5%-10%
|
4 Participants
n=5 Participants
|
|
Mitosis 10 HPF
Unknown
|
6 Participants
n=5 Participants
|
|
Mitosis 10 HPF
<2
|
6 Participants
n=5 Participants
|
|
Mitosis 10 HPF
2-20
|
5 Participants
n=5 Participants
|
|
Primary tumor surgery
Yes
|
6 Participants
n=5 Participants
|
|
Primary tumor surgery
No
|
11 Participants
n=5 Participants
|
|
Tumor stage at diagnosis
II
|
3 Participants
n=5 Participants
|
|
Tumor stage at diagnosis
III
|
1 Participants
n=5 Participants
|
|
Tumor stage at diagnosis
IV
|
13 Participants
n=5 Participants
|
|
Tumor relapse location
Hepatic
|
12 Participants
n=5 Participants
|
|
Tumor relapse location
Extra-hepatic
|
1 Participants
n=5 Participants
|
|
Tumor relapse location
Unknown
|
4 Participants
n=5 Participants
|
|
Somatostanine analogues prior the trial
Yes
|
7 Participants
n=5 Participants
|
|
Somatostanine analogues prior the trial
No
|
10 Participants
n=5 Participants
|
|
Baseline concomitant medication
Yes
|
16 Participants
n=5 Participants
|
|
Baseline concomitant medication
No
|
1 Participants
n=5 Participants
|
|
Weight
|
70.97 Kg
STANDARD_DEVIATION 15.01 • n=5 Participants
|
|
Height
|
166.71 cm
STANDARD_DEVIATION 7.74 • n=5 Participants
|
|
Body mass index (BMI)
|
25.46 kg/m^2
STANDARD_DEVIATION 4.75 • n=5 Participants
|
|
Body surface area (BSA)
|
1.79 m^2
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Blood pressure systolic (BPs)
|
134.82 mm Hg
STANDARD_DEVIATION 10.95 • n=5 Participants
|
|
Blood pressure diastolic (BPd)
|
79.12 mm Hg
STANDARD_DEVIATION 7.42 • n=5 Participants
|
|
Haemoglobin
|
13.82 g/dL
STANDARD_DEVIATION 1.21 • n=5 Participants
|
|
White blood cells
|
6.22 x10^9 cells/L
STANDARD_DEVIATION 2.17 • n=5 Participants
|
|
Absolute neutrophil count
|
4.52 x10^9 cells/L
STANDARD_DEVIATION 1.84 • n=5 Participants
|
|
Absolute Lymphocytes count
|
1.69 x10^9 cells/L
STANDARD_DEVIATION 0.41 • n=5 Participants
|
|
Platelet count
|
202.94 x10^9 cells/L
STANDARD_DEVIATION 77.34 • n=5 Participants
|
|
Sodium blood levels
|
139.22 mmol/L
STANDARD_DEVIATION 3.06 • n=5 Participants
|
|
Potassium blood levels
|
4.35 mmol/L
STANDARD_DEVIATION 0.35 • n=5 Participants
|
|
Calcium blood levels
|
9.18 mmol/L
STANDARD_DEVIATION 1.83 • n=5 Participants
|
|
Magnesium blood levels
|
1.9 mmol/L
STANDARD_DEVIATION 0.38 • n=5 Participants
|
|
Glucose
|
133.44 mmol/L
STANDARD_DEVIATION 59.92 • n=5 Participants
|
|
Creatinine
|
0.76 mg/dL
STANDARD_DEVIATION 0.17 • n=5 Participants
|
|
Aspartate AST (SGOT)
|
48.95 u/L
STANDARD_DEVIATION 40.18 • n=5 Participants
|
|
Alanine transaminase ALT (SGPT)
|
69.63 u/L
STANDARD_DEVIATION 61.12 • n=5 Participants
|
|
AST (SGOT)/ ALT (SGPT) (baseline)
|
0.83 Ratio (arbitrary units)
STANDARD_DEVIATION 0.30 • n=5 Participants
|
|
Total bilirubin
|
0.86 mg/dL
STANDARD_DEVIATION 0.58 • n=5 Participants
|
|
Gamma-glutamyltransferase (GGT)
|
351.25 u/L
STANDARD_DEVIATION 488.76 • n=5 Participants
|
|
Alkaline phosphatase (AP)
|
201.64 u/L
STANDARD_DEVIATION 183.95 • n=5 Participants
|
|
Albumin
|
4.28 mg/dL
STANDARD_DEVIATION 0.43 • n=5 Participants
|
|
Lactate dehydrogenase (LDH)
|
216.88 u/L
STANDARD_DEVIATION 83.41 • n=5 Participants
|
|
CG a tumor marker
|
474.41 ng/L
STANDARD_DEVIATION 626.35 • n=5 Participants
|
|
Enolase 1
|
31.92 ng/mL
STANDARD_DEVIATION 31.08 • n=5 Participants
|
|
Time between diagnosis (anatomical pathology) and treatment initiation in months
|
14.12 months
STANDARD_DEVIATION 22.72 • n=5 Participants
|
|
Time between diagnosis (anatomical pathology) and surgery in months
|
1.1 months
STANDARD_DEVIATION 2.94 • n=5 Participants
|
|
Time between diagnosis (anatomical pathology) and CT relapse in months
|
8.9 months
STANDARD_DEVIATION 13.77 • n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 36 monthsObjective response rate: percentage of patients in whom a complete response (CR) or a partial response (PR) is confirmed according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in relation to the total of the analyzed population. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
TH-302 + Sunitinib
n=17 Participants
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Objective Response Rate
CR or PR
|
3 Participants
|
|
Objective Response Rate
SD or PD
|
14 Participants
|
SECONDARY outcome
Timeframe: approximately 36 monthsTime between the start of study treatment to date of the first objective evidence of radiological progression or patient death due to any cause; which comes first.
Outcome measures
| Measure |
TH-302 + Sunitinib
n=17 Participants
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Progression Free Survival (PFS)
|
10.38 months
Interval 2.66 to 18.1
|
SECONDARY outcome
Timeframe: approximately 36 monthsIt is defined as the time between the start of study treatment to date of the first objective evidence of radiological progression.
Outcome measures
| Measure |
TH-302 + Sunitinib
n=17 Participants
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Time to Tumour Progression (TTP)
|
5.32 months
Interval 1.69 to 13.55
|
SECONDARY outcome
Timeframe: approximately 36 monthsIt is defined as the time between the start from the first documentation of objective response (CR or PR) which is subsequently confirmed until the first objective evidence of radiological progression or death from any cause. DR is calculated only in the subgroup of patients with an objective response (CR + PR).
Outcome measures
| Measure |
TH-302 + Sunitinib
n=3 Participants
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Duration of Response (DR)
|
18.48 months
Interval 4.2 to 38.31
|
SECONDARY outcome
Timeframe: approximately 36 monthsIt is defined as the time between the start of study treatment to date of death from any cause. If it were impossible to obtain confirmation of the death, survival will be censored with the date of the last Visit that it is satisfied that the patient was alive.
Outcome measures
| Measure |
TH-302 + Sunitinib
n=17 Participants
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Overall Survival (OR)
|
32.32 months
Interval 25.12 to 39.53
|
SECONDARY outcome
Timeframe: time between the date of signing the informed consent until 28 days after the last dose of study drug, , an average of 2 yearsSafety will be assessed according to the reports of adverse events, the frequency of treatment discontinuations due to adverse events, laboratory evaluations or ECG
Outcome measures
| Measure |
TH-302 + Sunitinib
n=17 Participants
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Safety (Adverse Events)
SAE
|
3 events
|
|
Safety (Adverse Events)
Deaths (all causes)
|
3 events
|
|
Safety (Adverse Events)
Deaths (SAE related)
|
1 events
|
|
Safety (Adverse Events)
AE
|
17 events
|
|
Safety (Adverse Events)
treatment discontinuation due to toxicity
|
4 events
|
SECONDARY outcome
Timeframe: approximately 36 monthsPopulation: we obtained samples from 13 patients for Cg A and 10 patients for Enolase 1
Assess the predictive/prognostic value of the analysed biomarkers in plasm and tumour.
Outcome measures
| Measure |
TH-302 + Sunitinib
n=13 Participants
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Biomarkers in Serum and Tumor Tissue
Cg A
|
197 ng/ml
Interval 37.2 to 2063.9
|
|
Biomarkers in Serum and Tumor Tissue
Enolase 1
|
15.06 ng/ml
Interval 8.6 to 92.89
|
Adverse Events
TH-302 + Sunitinib
Serious events: 3 serious events
Other events: 17 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
TH-302 + Sunitinib
n=17 participants at risk
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased subjects affected / exposed
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Hepatobiliary disorders
Biliary duct obstruction
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Endocrine disorders
Pancreatitis
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
Other adverse events
| Measure |
TH-302 + Sunitinib
n=17 participants at risk
TH-302 + Sunitinib. Single arm Study.
TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:
Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.
|
|---|---|
|
Vascular disorders
Hypertension
|
35.3%
6/17 • Number of events 6 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Vascular disorders
Vascular disorders - Other, brachial vein thrombosis
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
General disorders
Fatigue
|
82.4%
14/17 • Number of events 14 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
General disorders
General disorders and administration site conditions - Other, epigastralgia
|
17.6%
3/17 • Number of events 3 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
General disorders
Fever
|
17.6%
3/17 • Number of events 3 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
General disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
General disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, genital dryness
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis oral
|
58.8%
10/17 • Number of events 10 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - thoracic pain
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
52.9%
9/17 • Number of events 9 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
29.4%
5/17 • Number of events 5 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
17.6%
3/17 • Number of events 3 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Blood and lymphatic system disorders
Bilirrubin increased
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • Number of events 4 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Nervous system disorders
Myalgia
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Nervous system disorders
Dysesthesia
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Nervous system disorders
Paresthesia
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Eye disorders
Conjunctivitis
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
52.9%
9/17 • Number of events 9 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
17.6%
3/17 • Number of events 3 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: aerophagia
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: acute gastroenteritis
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, glossitis
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Gingivitis
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Anal ulcer
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Gastrointestinal disorders
Anal pain
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Renal and urinary disorders
Hematuria
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
29.4%
5/17 • Number of events 5 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
23.5%
4/17 • Number of events 4 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Erythema
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Unspecified Onycopathy
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Psoriasis
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Inguinal cutaneous toxicity
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, facial rash
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, eczematous facial rash
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
41.2%
7/17 • Number of events 7 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Metabolism and nutrition disorders
Dysgeusia
|
35.3%
6/17 • Number of events 6 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Metabolism and nutrition disorders
Nausea
|
29.4%
5/17 • Number of events 5 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Metabolism and nutrition disorders
Vomiting
|
23.5%
4/17 • Number of events 4 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Endocrine disorders
Pancreatitis
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Infections and infestations
Constipation
|
11.8%
2/17 • Number of events 2 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Infections and infestations
Pharyngitis
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
|
Infections and infestations
Nail infection
|
5.9%
1/17 • Number of events 1 • The security assessment period was between the date of the signed informed consent and up to 28 days after the last dose of study drug, an average of 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor commits to the timely dissemination of the results through scientific conferences and publications which will be responsible for the scientific coordinator and the translational study coordinator. The study coordinator reserves the option to choose your position in the different publications and reports that could be carried out of the study. The coordinator of the study will have a secure position within the authors. The rest of IPs will be assigned according to order of recruitment
- Publication restrictions are in place
Restriction type: OTHER