Trial Outcomes & Findings for Efficacy and Safety of Sunitinib in Metastatic Gastric Cancer (NCT NCT00411151)
NCT ID: NCT00411151
Last Updated: 2011-01-20
Results Overview
The primary endpoint is the ORR within the first 6 treatment cycles, defined as the percentage of participants with a confirmed reduction in tumor size fulfilling the criteria for complete or partial response (CR or PR) according to RECIST. CR=disappearance of all target lesions, PR=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions
COMPLETED
PHASE2
52 participants
one year
2011-01-20
Participant Flow
First patient in (FPI): 15.02.2007 Last patient out (LPO): 20.08.2009
Participant milestones
| Measure |
Sunitinib
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
| Measure |
Sunitinib
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
|
|---|---|
|
Overall Study
Death
|
38
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Trial prematurely closed
|
4
|
Baseline Characteristics
Efficacy and Safety of Sunitinib in Metastatic Gastric Cancer
Baseline characteristics by cohort
| Measure |
Sunitinib
n=52 Participants
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
|
|---|---|
|
Age Continuous
|
59 years
FULL_RANGE 12.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
100%
|
17 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
90%
|
15 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
80%
|
18 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
70%
|
2 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
60%
|
0 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
50%
|
0 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
40%
|
0 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
30%
|
0 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
20%
|
0 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
10%
|
0 Participants
n=5 Participants
|
|
Karnofsky Performance Status (KPS)
Missing
|
0 Participants
n=5 Participants
|
|
Localisation of adenocarcinoma
Stomach
|
36 Participants
n=5 Participants
|
|
Localisation of adenocarcinoma
Gastroesophageal junction
|
12 Participants
n=5 Participants
|
|
Localisation of adenocarcinoma
Lower esophagus
|
5 Participants
n=5 Participants
|
|
Localisation of adenocarcinoma
Missing
|
0 Participants
n=5 Participants
|
|
Grading of adenocarcinoma
1
|
0 Participants
n=5 Participants
|
|
Grading of adenocarcinoma
2
|
19 Participants
n=5 Participants
|
|
Grading of adenocarcinoma
3
|
26 Participants
n=5 Participants
|
|
Grading of adenocarcinoma
4
|
2 Participants
n=5 Participants
|
|
Grading of adenocarcinoma
Missing
|
5 Participants
n=5 Participants
|
|
Localisation of target lesions
Primary tumor
|
3 Participants
n=5 Participants
|
|
Localisation of target lesions
Lung
|
8 Participants
n=5 Participants
|
|
Localisation of target lesions
Liver
|
28 Participants
n=5 Participants
|
|
Localisation of target lesions
Lymph node truncus coeliacus
|
10 Participants
n=5 Participants
|
|
Localisation of target lesions
Lymph node mediastinum
|
11 Participants
n=5 Participants
|
|
Localisation of target lesions
Lymph node spleen/pancreas
|
3 Participants
n=5 Participants
|
|
Localisation of target lesions
Lymph node paraaortal caudal
|
9 Participants
n=5 Participants
|
|
Localisation of target lesions
Peritoneum
|
2 Participants
n=5 Participants
|
|
Localisation of target lesions
Soft tissue
|
5 Participants
n=5 Participants
|
|
Localisation of target lesions
Other
|
14 Participants
n=5 Participants
|
|
Localisation of target lesions
Missing
|
0 Participants
n=5 Participants
|
|
Total size of target lesions
|
62 mm
n=5 Participants
|
|
Localisation of non-target lesions
Primary tumor
|
1 Participants
n=5 Participants
|
|
Localisation of non-target lesions
Bone
|
1 Participants
n=5 Participants
|
|
Localisation of non-target lesions
Lung
|
4 Participants
n=5 Participants
|
|
Localisation of non-target lesions
Liver
|
15 Participants
n=5 Participants
|
|
Localisation of non-target lesions
Lymph node truncus coeliacus
|
4 Participants
n=5 Participants
|
|
Localisation of non-target lesions
Lymph node mediastinum
|
3 Participants
n=5 Participants
|
|
Localisation of non-target lesions
Lymph node paraaortal caudal
|
3 Participants
n=5 Participants
|
|
Localisation of non-target lesions
Peritoneum
|
3 Participants
n=5 Participants
|
|
Localisation of non-target lesions
Other
|
9 Participants
n=5 Participants
|
|
Localisation of non-target lesions
No non-target lesions
|
9 Participants
n=5 Participants
|
|
Localisation of non-target lesions
Missing
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.
The primary endpoint is the ORR within the first 6 treatment cycles, defined as the percentage of participants with a confirmed reduction in tumor size fulfilling the criteria for complete or partial response (CR or PR) according to RECIST. CR=disappearance of all target lesions, PR=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions
Outcome measures
| Measure |
Sunitinib
n=51 Participants
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
|
|---|---|
|
Objective Response Rate (ORR)
|
3.92 Participants (%)
Interval 0.48 to 13.46
|
SECONDARY outcome
Timeframe: one yearPopulation: Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.
PFS is defined as the time from first dose of trial medication to first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Sunitinib
n=51 Participants
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
|
|---|---|
|
Progression-Free Survival (PFS)
|
39 Days
Interval 36.0 to 58.0
|
SECONDARY outcome
Timeframe: one yearPopulation: Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.
OS is defined as the time from the first dose of trial medication to date of death due to any cause.
Outcome measures
| Measure |
Sunitinib
n=51 Participants
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
|
|---|---|
|
Overall Survival (OS)
|
177 Days
Interval 106.0 to 278.0
|
SECONDARY outcome
Timeframe: one yearPopulation: Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.
One-year survival is defined as the percentage of participants surviving for at least one year after first dose of trial medication.
Outcome measures
| Measure |
Sunitinib
n=51 Participants
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
|
|---|---|
|
One-Year Survival
|
23.7 Participants (%)
Interval 12.8 to 36.5
|
SECONDARY outcome
Timeframe: one yearPopulation: Safety population comprises all patients registered.
The number of participants with at least one adverse event was measured.
Outcome measures
| Measure |
Sunitinib
n=52 Participants
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
|
|---|---|
|
Adverse Events
|
52 Participants
|
SECONDARY outcome
Timeframe: one yearPopulation: Safety population comprises all patients registered.
The number of participants with at least one Serious Adverse Event was measured.
Outcome measures
| Measure |
Sunitinib
n=52 Participants
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
|
|---|---|
|
Safety and Tolerability: Serious Adverse Events
|
26 Participants
|
SECONDARY outcome
Timeframe: one yearPopulation: Safety population comprises all patients registered.
Outcome measures
| Measure |
Sunitinib
n=52 Participants
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
|
|---|---|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Fatigue
|
19 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Nausea
|
16 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Mucosal inflammation
|
9 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Anorexia
|
9 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Vomiting
|
8 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Diarrhoea
|
8 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Dysgeusia
|
6 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Headache
|
5 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Paraesthesia
|
5 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Cough
|
5 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Abdominal pain
|
5 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Palmar-plantar erythrodysaesthesia syndrome
|
5 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Blood bilirubin increased
|
5 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Leukopenia
|
11 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Thrombocytopenia
|
11 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Neutropenia
|
8 Participants
|
|
Safety and Tolerability: Adverse Events in ≥10% of Patients
Anaemia
|
7 Participants
|
Adverse Events
Sunitinib
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
M. Kabisch
Interdisciplinary Center for Clinical Trials (IZKS Mainz)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place