Text Size

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

This study has been terminated.
(The study was terminated on 26 February 2013. Risk-benefit assessment is no longer positive and does not support further development)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00915278
First received: June 3, 2009
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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 patients pre treated or unresponsive to standard therapies.


Condition Intervention Phase
Advanced Non-Hematologic Malignancies
 Drug: PF-04605412
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Immunogenicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Ktrans and related dynamic contrast-enhanced magnetic resonance imaging (DCE- MRI) parameters [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Objective Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04605412 Drug: PF-04605412
PF-04605412 will be administered as 2 hr IV infusion every 4 or 2 weeks. Start dose is 7.5 mg. Multiple doses are foreseen. Treatment will continue until intolerable toxicity, progression of disease or patient's refusal

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915278

Locations
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232-5536
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232-7610
United Kingdom
Pfizer Investigational Site
Tooting, London, United Kingdom, SW17 0QT
Pfizer Investigational Site
North Cheam, Surrey, United Kingdom, SM3 9DW
Pfizer Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00915278     History of Changes
Other Study ID Numbers: B1001001
Study First Received: June 3, 2009
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Neoplasms
monoclonal antibody
PF-04605412
advanced metastatic solid tumors

Additional relevant MeSH terms:
Neoplasms
Antibodies
Antibodies, Monoclonal
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013