Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors

NCT ID: NCT00879684

Last Updated: 2015-01-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.

Detailed Description

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Conditions

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Advanced Solid Tumors Neoplasms Carcinoma Cancer Malignancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

CVX-060

Intervention Type BIOLOGICAL

Weekly, intravenous dose

Interventions

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CVX-060

Weekly, intravenous dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy.
* Adequate coagulation, liver, and renal function.
* Candidate for DCE-MRI evaluations.
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

Exclusion Criteria

* Evidence of significant bleeding problems.
* History of certain gastrointestinal problems including fistula and abscess.
* Chronic, uncontrolled hypertension.
* Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Scottsdale Medical Imaging, Ltd.

Scottsdale, Arizona, United States

Site Status

Premiere Oncology of Arizona

Scottsdale, Arizona, United States

Site Status

Premiere Oncology, A Medical Corporation

Santa Monica, California, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CVX-060-101

Identifier Type: OTHER

Identifier Source: secondary_id

B1131002

Identifier Type: -

Identifier Source: org_study_id

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