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Efficacy and Safety of Sunitinib in Metastatic Gastric Cancer

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ClinicalTrials.gov Identifier: NCT00411151
Recruitment Status : Completed
First Posted : December 13, 2006
Results First Posted : January 14, 2011
Last Update Posted : January 20, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Johannes Gutenberg University Mainz

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastric Adenocarcinoma
Barrett Esophagus
Intervention Drug: Sunitinib-Malate
Enrollment 52
Recruitment Details First patient in (FPI): 15.02.2007 Last patient out (LPO): 20.08.2009
Pre-assignment Details  
Arm/Group Title Sunitinib
Hide Arm/Group Description open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
Period Title: Overall Study
Started 52
Completed 5
Not Completed 47
Reason Not Completed
Death             38
Withdrawal by Subject             2
Lost to Follow-up             2
Protocol Violation             1
Trial prematurely closed             4
Arm/Group Title Sunitinib
Hide Arm/Group Description open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants
59
(28 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
12
  23.1%
Male
40
  76.9%
Karnofsky Performance Status (KPS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants
100% 17
90% 15
80% 18
70% 2
60% 0
50% 0
40% 0
30% 0
20% 0
10% 0
Missing 0
[1]
Measure Description: KPS is the Karnofsky Lansky Score. Higher values in the KPS represent a better physical condition. 100%=normal, 90%=able to carry on normal activity, 80%=normal activity with effort, 70%=cares for self but unable to carry on normal activity, 60%=requires occasional assistance, 50%=requires considerable assistance and frequent medical care, 40%=disabled, requires special care and assistance, 30%=severely disabled and hospitalization indicated but death not imminent, 20%=very sick and requires hospitalization, 10%=moribund and fatal processes progressing rapidly, 0%=dead
Localisation of adenocarcinoma   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants
Stomach 36
Gastroesophageal junction 12
Lower esophagus 5
Missing 0
[1]
Measure Description: Note that multiple answers are permitted.
Grading of adenocarcinoma   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants
1 0
2 19
3 26
4 2
Missing 5
[1]
Measure Description:

Grading of adenocarcinoma is the tumor grading according to UICC.

1 (low grade)=well differentiated, 2 (intermediate grade)=differentiated, 3 (high grade)=poorly differentiated, 4 (high grade)=undifferentiated

Localisation of target lesions   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants
Primary tumor 3
Lung 8
Liver 28
Lymph node truncus coeliacus 10
Lymph node mediastinum 11
Lymph node spleen/pancreas 3
Lymph node paraaortal caudal 9
Peritoneum 2
Soft tissue 5
Other 14
Missing 0
[1]
Measure Description: Note that multiple answers are permitted.
Total size of target lesions  
Median (Full Range)
Unit of measure:  Mm
Number Analyzed 52 participants
62
(10 to 236)
Localisation of non-target lesions   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants
Primary tumor 1
Bone 1
Lung 4
Liver 15
Lymph node truncus coeliacus 4
Lymph node mediastinum 3
Lymph node paraaortal caudal 3
Peritoneum 3
Other 9
No non-target lesions 9
Missing 9
[1]
Measure Description: Note that multiple answers are permitted.
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description 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
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Participants (%)
3.92
(0.48 to 13.46)
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: Days
39
(36 to 58)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from the first dose of trial medication to date of death due to any cause.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: Days
177
(106 to 278)
4.Secondary Outcome
Title One-Year Survival
Hide Description One-year survival is defined as the percentage of participants surviving for at least one year after first dose of trial medication.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Participants (%)
23.7
(12.8 to 36.5)
5.Secondary Outcome
Title Adverse Events
Hide Description The number of participants with at least one adverse event was measured.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population comprises all patients registered.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: Participants
52
6.Secondary Outcome
Title Safety and Tolerability: Serious Adverse Events
Hide Description The number of participants with at least one Serious Adverse Event was measured.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population comprises all patients registered.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: Participants
26
7.Secondary Outcome
Title Safety and Tolerability: Adverse Events in ≥10% of Patients
Hide Description [Not Specified]
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population comprises all patients registered.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: Participants
Fatigue 19
Nausea 16
Mucosal inflammation 9
Anorexia 9
Vomiting 8
Diarrhoea 8
Dysgeusia 6
Headache 5
Paraesthesia 5
Cough 5
Abdominal pain 5
Palmar-plantar erythrodysaesthesia syndrome 5
Blood bilirubin increased 5
Leukopenia 11
Thrombocytopenia 11
Neutropenia 8
Anaemia 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib
Hide Arm/Group Description open-label and uncontrolled treatment cycle "4+2": Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)
All-Cause Mortality
Sunitinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib
Affected / at Risk (%)
Total   0/52 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sunitinib
Affected / at Risk (%)
Total   0/52 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M. Kabisch
Organization: Interdisciplinary Center for Clinical Trials (IZKS Mainz)
Phone: ++49 (0)6131-179922
EMail: kabisch@izks-mainz.de
Layout table for additonal information
Responsible Party: Markus Moehler, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT00411151     History of Changes
Other Study ID Numbers: GC-SU-2006
KKS 2005-015
First Submitted: December 11, 2006
First Posted: December 13, 2006
Results First Submitted: November 29, 2010
Results First Posted: January 14, 2011
Last Update Posted: January 20, 2011