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

Last updated on November 15, 2019

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Study Location
Pfizer Investigational Site
Nanjing, Jiangsu, 210002 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stomach Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Clinically relevant ascites (i.e. requiring paracentesis)

- Severe weight loss

- NCI CTCAE Grade 3 hemorrhage

- 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

NCT00226811
Pfizer
Completed
An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy

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Descriptive Information
Brief Title  ICMJE An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stomach Neoplasms
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Drug: Sunitinib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2009)
78
Original Enrollment  ICMJE
 (submitted: September 23, 2005)
160
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion DateMay 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Portugal,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00226811
Other Study ID Numbers  ICMJE A6181054
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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