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

Tracking Information

First Received Date ^ICMJE

June 3, 2009

Last Updated Date

March 28, 2013

Start Date ^ICMJE

September 2009

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Maximum Tolerated Dose [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00915278 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Safety [ 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 patients pre treated or unresponsive to standard therapies.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Advanced Non-Hematologic Malignancies

Intervention ^ICMJE

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

Study Arm (s)

Experimental: PF-04605412

Intervention: Drug: PF-04605412

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00915278

Other Study ID Numbers ^ICMJE

B1001001

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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