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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Non-Hematologic Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-04605412

Group Type EXPERIMENTAL

PF-04605412

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No