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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
N/A
Not Enrolling
Both
Colorectal Neoplasms

Thank you

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
procedure.

Type of Study:

Interventional

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:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4061020

NCT ID:

NCT00460603

Start Date:

January 2006

Completion Date:

November 2012

Related Keywords:

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

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteSalt Lake City, Utah  84112