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A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Anti-A5B1 Integrin Monoclonal Antibody PF-04605412 Administered Intravenously To Adult Patients With Advanced Or Metastatic Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Non-Hematologic Malignancies

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Trial Information

A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Anti-A5B1 Integrin Monoclonal Antibody PF-04605412 Administered Intravenously To Adult Patients With Advanced Or Metastatic Solid Tumors


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1001001

NCT ID:

NCT00915278

Start Date:

September 2009

Completion Date:

January 2013

Related Keywords:

  • Advanced Non-hematologic Malignancies
  • Neoplasms
  • monoclonal antibody
  • PF-04605412
  • advanced metastatic solid tumors
  • Neoplasms

Name

Location

Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteBristol, Tennessee  37620