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A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combinations With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer Preceded By A Phase 1 Portion

Phase 1/Phase 2
18 Years
Not Enrolling
Colorectal Neoplasms

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Trial Information

A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combinations With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer Preceded By A Phase 1 Portion

Inclusion Criteria:

- (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.

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Objective Response: Phase 2

Outcome Description:

Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.

Outcome Time Frame:

Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

November 2012

Related Keywords:

  • Colorectal Neoplasms
  • GI neoplasms (phase 1)
  • Neoplasms
  • Colorectal Neoplasms



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