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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Stomach Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall Response

Outcome Time Frame:

From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181054

NCT ID:

NCT00226811

Start Date:

January 2006

Completion Date:

May 2008

Related Keywords:

  • Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms

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