Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer

Completed · Phase 1/Phase 2

Conditions studied: Colorectal Neoplasms

In brief

To determine the safety and efficacy of AG-013736 in combination with other standard of care medication in patients with first line metastatic colorectal cancer.

Key facts

Study ID

NCT00460603

Run by

Pfizer

People needed

187

Starts

2006-01-01

Expected to finish

2012-11-01

Last updated by the study team

2013-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment
• (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy.
• Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last treatment was > 12 months prior to enrollment,
• Patients must have measurable disease by RECIST and if any history of hypertension, it must be controlled with medication.

You may not qualify if…

• Prior system therapy for advanced CRC (Ph 2 portion only)
• Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.
• Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)
• Prior radiation, major surgery, or investigational agent within 4 weeks of study entry except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries should be completed > 2 weeks of enrollment and be fully recovered from any procedure.

Where it is running

• Pfizer Investigational Site — Huntsville, Alabama, United States
• Pfizer Investigational Site — Huntsville, Alabama, United States
• Pfizer Investigational Site — Mobile, Alabama, United States
• Pfizer Investigational Site — Antioch, California, United States
• Pfizer Investigational Site — Colton, California, United States
• Pfizer Investigational Site — Corona, California, United States
• Pfizer Investigational Site — Gilroy, California, United States
• Pfizer Investigational Site — Glendora, California, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — Pasadena, California, United States
• Pfizer Investigational Site — Pleasant Hill, California, United States
• Pfizer Investigational Site — Pomona, California, United States
• Pfizer Investigational Site — Rancho Cucamonga, California, United States
• Pfizer Investigational Site — Rancho Mirage, California, United States
• Pfizer Investigational Site — Redlands, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Leandro, California, United States
• Pfizer Investigational Site — West Covina, California, United States
• Pfizer Investigational Site — Auroa, Colorado, United States
• Pfizer Investigational Site — Boulder, Colorado, United States
• Pfizer Investigational Site — Colorado Springs, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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