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An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00226811
First received: September 23, 2005
Last updated: December 10, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Stomach Neoplasms
 Drug: Sunitinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Best Overall Response [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
  • Objective Response (Complete Response (CR) or Partial Response (PR)) [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Duration of Response (CR or PR) [ Time Frame: Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death ] [ Designated as safety issue: No ]
  • Time to Tumor Progression (TTP) [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: From start of study treatment until death ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
 Drug: Sunitinib
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226811

Locations
China, Guang dong
Pfizer Investigational Site
Guangzhou, Guang dong, China, 510515
China, Jiangsu
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210002
China
Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Beijing, China, 100036
Hong Kong
Pfizer Investigational Site
Hong Kong, Hong Kong
Pfizer Investigational Site
Shatin, Hong Kong
Italy
Pfizer Investigational Site
Ancona, Italy, 60020
Pfizer Investigational Site
Genova, Italy, 16132
Japan
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Pfizer Investigational Site
Suntougun, Shizuoka, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Portugal
Pfizer Investigational Site
Porto, Portugal, 4200-072
Taiwan
Pfizer Investigational Site
Kwei-Shan, Taoyuan, Taiwan, 333
Pfizer Investigational Site
Taipei, Taiwan, 100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00226811     History of Changes
Other Study ID Numbers: A6181054
Study First Received: September 23, 2005
Results First Received: May 14, 2009
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Sunitinib
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013