Status:

TERMINATED

A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors

Lead Sponsor:

Pfizer

Conditions:

Advanced Non-Hematologic Malignancies

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose) in cancer patient...

Eligibility Criteria

Inclusion

  • Histologically or cytologically confirmed advanced measurable or evaluable solid tumors unresponsive to currently available therapies, or for which there is no curative therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1
  • Life expectancy more than12 weeks
  • Adequate bone marrow, liver and renal function

Exclusion

  • Known brain metastasis
  • Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of start of screening procedures
  • Major surgical procedure within 4 weeks of start of screening procedures
  • Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2013

Estimated Enrollment :

33 Patients enrolled

Trial Details

Trial ID

NCT00915278

Start Date

September 1 2009

End Date

January 1 2013

Last Update

April 4 2014

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States, 19111

2

Pfizer Investigational Site

Nashville, Tennessee, United States, 37232-5536

3

Pfizer Investigational Site

Nashville, Tennessee, United States, 37232-7610

4

Pfizer Investigational Site

Nashville, Tennessee, United States, 37232