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

NCT ID: NCT00226811

Last Updated: 2015-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-05-31

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.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sunitinib

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Pfizer Inc

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Nanjing, Jiangsu, China

Pfizer Investigational Site

Beijing, , China

Pfizer Investigational Site

Beijing, , China

Pfizer Investigational Site

Guangzhou, , China

Pfizer Investigational Site

Hong Kong, , Hong Kong

Pfizer Investigational Site

Shatin, , Hong Kong

Pfizer Investigational Site

Ancona, , Italy

Pfizer Investigational Site

Genova, , Italy

Pfizer Investigational Site

Kashiwa, Chiba, Japan

Pfizer Investigational Site

Suntougun, Shizuoka, Japan

Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

Pfizer Investigational Site

Porto, , Portugal

Pfizer Investigational Site

Seoul, , South Korea

Pfizer Investigational Site

Seoul, , South Korea

Pfizer Investigational Site

Seoul, , South Korea

Pfizer Investigational Site

Seoul, , South Korea

Pfizer Investigational Site

Kwei-Shan, Taoyuan, Taiwan

Pfizer Investigational Site

Taipei, , Taiwan

Countries

China; Hong Kong; Italy; Japan; Portugal; South Korea; Taiwan

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181054&StudyName=An%20International%20Phase%202%20Study%20Of%20SU011248%20In%20Patients%20With%20Advanced%20/%20Metastatic%20Gastric%20Cancer%20Failing%20Chemotherapy

To obtain contact information for a study center near you, click here.

Other Identifiers

A6181054

Identifier Type: -

Identifier Source: org_study_id