Trial Outcomes & Findings for Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO) (NCT NCT00661830)
NCT ID: NCT00661830
Last Updated: 2013-11-21
Results Overview
The primary endpoint is the progression-free survival (PFS) defined as the time from start of treatment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first during treatment or follow-up period. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation anti-cancer therapy. Acceptable documentation of objective disease progression status consists of objective assessments using CT scan assessment method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
one year
Results posted on
2013-11-21
Participant Flow
First patient in was on 27MAY2008 Last patient out was on 20JUL2011
Six patients were enrolled but never treated. 97 patients were treated with study drug.
Participant milestones
| Measure |
Gemcitabine + Sorafenib
Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
|
Gemcitabine + Placebo
Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
48
|
|
Overall Study
COMPLETED
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
40
|
42
|
Reasons for withdrawal
| Measure |
Gemcitabine + Sorafenib
Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
|
Gemcitabine + Placebo
Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo
|
|---|---|---|
|
Overall Study
Death
|
37
|
33
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Other reason
|
1
|
5
|
Baseline Characteristics
Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO)
Baseline characteristics by cohort
| Measure |
Gemcitabine + Sorafenib
n=49 Participants
Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
|
Gemcitabine + Placebo
n=48 Participants
Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.59 years
STANDARD_DEVIATION 9.01 • n=5 Participants
|
63.23 years
STANDARD_DEVIATION 11.92 • n=7 Participants
|
62.91 years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Type of Adenocarcinoma
Adeno carcinoma, gall bladder
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Type of Adenocarcinoma
Adeno carcinoma, intrahepatic bile ducts
|
33 participants
n=5 Participants
|
29 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Type of Adenocarcinoma
Adeno carcinoma, hepatic metastases
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Grading of adenocarcinoma
1 (well differentiated)
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Grading of adenocarcinoma
2 (moderately differentiated)
|
23 participants
n=5 Participants
|
30 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Grading of adenocarcinoma
3 (poorly differentiated)
|
20 participants
n=5 Participants
|
13 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Grading of adenocarcinoma
4 (undifferentiated)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Grading of adenocarcinoma
Missing
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Time since histological diagnosis
|
158.86 days
STANDARD_DEVIATION 347.69 • n=5 Participants
|
275.81 days
STANDARD_DEVIATION 748.51 • n=7 Participants
|
216.73 days
STANDARD_DEVIATION 581.55 • n=5 Participants
|
|
ECOG Performance Status
0
|
30 participants
n=5 Participants
|
35 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
ECOG Performance Status
1
|
17 participants
n=5 Participants
|
8 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
ECOG Performance Status
2
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
ECOG Performance Status
3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
ECOG Performance Status
4
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
ECOG Performance Status
Missing
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Number of target lesions
1
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Number of target lesions
2
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Number of target lesions
3
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Number of target lesions
4
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Number of target lesions
5
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Number of target lesions
6
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Number of target lesions
7
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Number of non-target lesions
1
|
23 participants
n=5 Participants
|
16 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Number of non-target lesions
2
|
6 participants
n=5 Participants
|
16 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Number of non-target lesions
3
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Number of non-target lesions
4
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Number of non-target lesions
5
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of non-target lesions
Missing
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Sum Sizes of target lesions
|
89.17 mm
STANDARD_DEVIATION 56.29 • n=5 Participants
|
95.02 mm
STANDARD_DEVIATION 54.07 • n=7 Participants
|
92.06 mm
STANDARD_DEVIATION 54.07 • n=5 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: All subjects who receive at least one dose of trial treatment are included in the analysis.
The primary endpoint is the progression-free survival (PFS) defined as the time from start of treatment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first during treatment or follow-up period. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation anti-cancer therapy. Acceptable documentation of objective disease progression status consists of objective assessments using CT scan assessment method.
Outcome measures
| Measure |
Gemcitabine + Sorafenib
n=49 Participants
Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
|
Gemcitabine + Placebo
n=48 Participants
Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo
|
|---|---|---|
|
Progression-free Survival (PFS)
|
91 days
Interval 54.0 to 218.0
|
148 days
Interval 105.0 to 233.0
|
SECONDARY outcome
Timeframe: one yearPopulation: All subjects who receive at least one dose of trial treatment are included in the analysis
Overall Survival (OS) is measured from start of treatment to death due to any cause until end of follow-up period. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored at the date of the last observation.
Outcome measures
| Measure |
Gemcitabine + Sorafenib
n=49 Participants
Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
|
Gemcitabine + Placebo
n=48 Participants
Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo
|
|---|---|---|
|
Overall Survival
|
255 days
Interval 166.0 to 384.0
|
341 days
Interval 306.0 to 488.0
|
SECONDARY outcome
Timeframe: one yearPopulation: All subjects who receive at least one dose of trial treatment are included in the analysis.
Best Overall Response (BOR) is defined as the best tumor response (confirmed partial or complete response, stable disease) that is achieved during treatment or within 30 days after termination of active therapy that is confirmed according to the RECIST tumor response criteria. Best response is determined from the sequence of responses assessed. For complete response (CR) or partial response (PR), best response must be confirmed by a second assessment within 4 -6 weeks. Two objective status determinations of CR before progression are required for a best response of CR. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Best response of Stable Disease (SD) is defined as disease that does not meet the criteria of CR, PR or Progressive Disease (PD) and has been evaluated at least one time, at least 6 weeks after baseline assessment.
Outcome measures
| Measure |
Gemcitabine + Sorafenib
n=49 Participants
Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
|
Gemcitabine + Placebo
n=48 Participants
Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo
|
|---|---|---|
|
Best Overall Response
Complete response
|
0 participants
|
0 participants
|
|
Best Overall Response
Partial response
|
4 participants
|
3 participants
|
|
Best Overall Response
Stable disease
|
24 participants
|
27 participants
|
|
Best Overall Response
Progressive disease
|
0 participants
|
0 participants
|
|
Best Overall Response
Missing
|
21 participants
|
18 participants
|
SECONDARY outcome
Timeframe: one yearPopulation: All subjects who receive at least one dose of trial treatment and had no progression during the trial are included in the analysis
Time to Objective Response (OR) is defined as the time from start of treatment to objective tumor response (CR or PR) is first documented according to the RECIST tumor response criteria during treatment or until 30 days after termination of active therapy. Response must subsequently be confirmed. For subjects failing to achieve an objective response and who did not progress during the trial, time to objective response will be censored at their last date of tumor evaluation.
Outcome measures
| Measure |
Gemcitabine + Sorafenib
n=24 Participants
Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
|
Gemcitabine + Placebo
n=25 Participants
Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo
|
|---|---|---|
|
Time to Objective Response
|
NA days
it was not possible to calculate the median due to high number of censored observations
|
NA days
it was not possible to calculate the median due to high number of censored observations
|
Adverse Events
Gemcitabine + Sorafenib
Serious events: 33 serious events
Other events: 47 other events
Deaths: 0 deaths
Gemcitabine + Placebo
Serious events: 35 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine + Sorafenib
n=49 participants at risk
Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
|
Gemcitabine + Placebo
n=48 participants at risk
Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo
|
|---|---|---|
|
General disorders
Fever
|
12.2%
6/49 • Number of events 8
|
10.4%
5/48 • Number of events 6
|
|
General disorders
General physical health deterioration
|
12.2%
6/49 • Number of events 9
|
12.5%
6/48 • Number of events 6
|
|
General disorders
Pain
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
General disorders
Oedema
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
General disorders
Device occlusion
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Eye disorders
Cataract
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Surgical and medical procedures
Bile duct stent insertion
|
2.0%
1/49 • Number of events 2
|
0.00%
0/48
|
|
Surgical and medical procedures
Biliary drainage
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/49
|
4.2%
2/48 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/49
|
4.2%
2/48 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
3/49 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/49
|
2.1%
1/48 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49 • Number of events 1
|
2.1%
1/48 • Number of events 2
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Gastrointestinal disorders
Peritonitis
|
4.1%
2/49 • Number of events 2
|
0.00%
0/48
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
3/49 • Number of events 4
|
6.2%
3/48 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
|
Nervous system disorders
Convulsion
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Nervous system disorders
Somnolence
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Cardiac disorders
Acute coronary syndrome
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Infections and infestations
Cholangitis suppurative
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Infections and infestations
Erysipelas
|
0.00%
0/49
|
4.2%
2/48 • Number of events 2
|
|
Infections and infestations
Biliary tract infection
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Infections and infestations
Gangrene
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Infections and infestations
Infection
|
4.1%
2/49 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
Device related infection
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Hepatobiliary disorders
Cholangitis
|
14.3%
7/49 • Number of events 7
|
6.2%
3/48 • Number of events 4
|
|
Hepatobiliary disorders
Cholestasis
|
8.2%
4/49 • Number of events 4
|
4.2%
2/48 • Number of events 2
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Cachexia
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Investigations
C-reactive protein increased
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine + Sorafenib
n=49 participants at risk
Gemcitabine + Sorafenib
Sorafenib : Sorafenib 400 mg bid orally continuously
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
|
Gemcitabine + Placebo
n=48 participants at risk
Gemcitabine + Placebo
Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.
Placebo : Placebo
|
|---|---|---|
|
General disorders
Fatigue
|
53.1%
26/49 • Number of events 32
|
58.3%
28/48 • Number of events 32
|
|
General disorders
Pyrexia
|
22.4%
11/49 • Number of events 17
|
31.2%
15/48 • Number of events 26
|
|
General disorders
General physical health deterioration
|
0.00%
0/49
|
10.4%
5/48 • Number of events 6
|
|
General disorders
Oedema peripheral
|
8.2%
4/49 • Number of events 4
|
22.9%
11/48 • Number of events 14
|
|
General disorders
Influenza like illness
|
8.2%
4/49 • Number of events 4
|
6.2%
3/48 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.2%
5/49 • Number of events 5
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
3/49 • Number of events 3
|
12.5%
6/48 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.4%
10/49 • Number of events 11
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
8/49 • Number of events 8
|
12.5%
6/48 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.1%
3/49 • Number of events 3
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.5%
12/49 • Number of events 12
|
2.1%
1/48 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
32.7%
16/49 • Number of events 17
|
20.8%
10/48 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.1%
3/49 • Number of events 4
|
4.2%
2/48 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.2%
6/49 • Number of events 7
|
10.4%
5/48 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.2%
4/49 • Number of events 4
|
4.2%
2/48 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
30.6%
15/49 • Number of events 19
|
4.2%
2/48 • Number of events 3
|
|
Blood and lymphatic system disorders
Anaemia
|
22.4%
11/49 • Number of events 13
|
31.2%
15/48 • Number of events 15
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.6%
15/49 • Number of events 22
|
33.3%
16/48 • Number of events 23
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.1%
3/49 • Number of events 4
|
4.2%
2/48 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.2%
4/49 • Number of events 6
|
14.6%
7/48 • Number of events 11
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
44.9%
22/49 • Number of events 79
|
47.9%
23/48 • Number of events 45
|
|
Gastrointestinal disorders
Abdominal pain
|
16.3%
8/49 • Number of events 11
|
8.3%
4/48 • Number of events 4
|
|
Gastrointestinal disorders
Ascites
|
4.1%
2/49 • Number of events 2
|
12.5%
6/48 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhoea
|
34.7%
17/49 • Number of events 24
|
27.1%
13/48 • Number of events 13
|
|
Gastrointestinal disorders
Vomiting
|
20.4%
10/49 • Number of events 11
|
20.8%
10/48 • Number of events 16
|
|
Gastrointestinal disorders
Oral disorder
|
20.4%
10/49 • Number of events 11
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.2%
4/49 • Number of events 5
|
0.00%
0/48
|
|
Gastrointestinal disorders
Constipation
|
22.4%
11/49 • Number of events 11
|
22.9%
11/48 • Number of events 12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.3%
8/49 • Number of events 9
|
18.8%
9/48 • Number of events 14
|
|
Gastrointestinal disorders
Stomatitis
|
12.2%
6/49 • Number of events 6
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
28.6%
14/49 • Number of events 15
|
52.1%
25/48 • Number of events 31
|
|
Nervous system disorders
Headache
|
6.1%
3/49 • Number of events 3
|
10.4%
5/48 • Number of events 6
|
|
Nervous system disorders
Paraesthesia
|
16.3%
8/49 • Number of events 9
|
12.5%
6/48 • Number of events 6
|
|
Nervous system disorders
Polyneuropathy
|
6.1%
3/49 • Number of events 3
|
0.00%
0/48
|
|
Nervous system disorders
Dizziness
|
2.0%
1/49 • Number of events 1
|
16.7%
8/48 • Number of events 9
|
|
Vascular disorders
Hypertension
|
10.2%
5/49 • Number of events 7
|
6.2%
3/48 • Number of events 3
|
|
Vascular disorders
Hypertensive crisis
|
6.1%
3/49 • Number of events 4
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
Infection
|
2.0%
1/49 • Number of events 1
|
14.6%
7/48 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
7/49 • Number of events 9
|
10.4%
5/48 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.2%
5/49 • Number of events 9
|
6.2%
3/48 • Number of events 5
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.4%
11/49 • Number of events 13
|
16.7%
8/48 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.2%
4/49 • Number of events 4
|
10.4%
5/48 • Number of events 5
|
|
Investigations
Weight decreased
|
24.5%
12/49 • Number of events 12
|
10.4%
5/48 • Number of events 5
|
|
Investigations
Haemoglobin decreased
|
6.1%
3/49 • Number of events 3
|
0.00%
0/48
|
|
Psychiatric disorders
Depression
|
0.00%
0/49
|
6.2%
3/48 • Number of events 3
|
|
Psychiatric disorders
Sleep disorder
|
6.1%
3/49 • Number of events 3
|
4.2%
2/48 • Number of events 2
|
Additional Information
A. Kaiser
Interdisciplinary Center for Clinical Trials (IZKS Mainz)
Phone: ++49(0)6131-179921
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place