An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Progressing Or Recurring After One Prior Chemotherapy
1 other identifier
interventional
78
7 countries
18
Brief Summary
The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2006
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2005
CompletedFirst Posted
Study publicly available on registry
September 27, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
November 26, 2009
CompletedMarch 30, 2015
March 1, 2015
2.3 years
September 23, 2005
May 14, 2009
March 10, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Best Overall Response
Number of patients with best overall response = complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Objective Response (Complete Response (CR) or Partial Response (PR))
Number of patients with Objective Response (OR): confirmed CR or confirmed PR according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Secondary Outcomes (5)
Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks
From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or clinical benefit response for at least 24 weeks on study
Duration of Response (CR or PR)
Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer
Progression-Free Survival
From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death
Time to Tumor Progression (TTP)
From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Overall Survival
From start of study treatment until death
Study Arms (1)
A
EXPERIMENTAL50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed
Interventions
50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed
Eligibility Criteria
You may qualify if:
- Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented
- Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred \> 6 months after adjuvant therapy completion
- Evidence of measurable disease by radiographic technique
- Adequate organ function.
You may not qualify if:
- Clinically relevant ascites (i.e. requiring paracentesis)
- Severe weight loss
- NCI CTCAE Grade 3 hemorrhage \<4 weeks of starting study treatment
- Diagnosis of second malignancy within last 3 years
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
- Known HIV
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (18)
Pfizer Investigational Site
Nanjing, Jiangsu, 210002, China
Pfizer Investigational Site
Beijing, 100036, China
Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Guangzhou, 510515, China
Pfizer Investigational Site
Hong Kong, Hong Kong
Pfizer Investigational Site
Shatin, Hong Kong
Pfizer Investigational Site
Ancona, 60020, Italy
Pfizer Investigational Site
Genova, 16132, Italy
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Pfizer Investigational Site
Suntougun, Shizuoka, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Pfizer Investigational Site
Porto, 4200-072, Portugal
Pfizer Investigational Site
Seoul, 110-744, South Korea
Pfizer Investigational Site
Seoul, 120-752, South Korea
Pfizer Investigational Site
Seoul, 135-710, South Korea
Pfizer Investigational Site
Seoul, 138-736, South Korea
Pfizer Investigational Site
Kwei-Shan, Taoyuan, 333, Taiwan
Pfizer Investigational Site
Taipei, 100, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 23, 2005
First Posted
September 27, 2005
Study Start
January 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
March 30, 2015
Results First Posted
November 26, 2009
Record last verified: 2015-03