A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors (CVX-045-101)

December 10, 2010 updated by: Pfizer

A Multicenter, Open-Label, 2-Stage, Phase 1, Clinical Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-045, A Thrombospondin-1 Mimetic, Anti-Angiogenic Agent, In Patients With Advanced Solid Tumors

The purpose of the study is to determine safety and tolerability of CVX-045 in patients with advanced solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Pfizer Investigational Site
    • California
      • Santa Monica,, California, United States, 90404
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 evaluation.
  • ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria:

  • Evidence of bleeding problems.
  • Uncontrolled hypertension.
  • Certain gastrointestinal problems including fistula and abscess.
  • Patients with primary brain cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: CVX-045
Weekly, intravenous dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors
Time Frame: Throughout duration of study
Throughout duration of study
To identify and characterize CVX-045-related adverse events (AEs)
Time Frame: Throughout duration of study
Throughout duration of study

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the plasma pharmacokinetics (PK) of CVX-045
Time Frame: Days 1, 4, 8, 15, 29
Days 1, 4, 8, 15, 29
To determine a recommended Phase 2 dose of CVX-045
Time Frame: End of study
End of study
To evaluate the potential for immunogenicity of CVX-045
Time Frame: Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU
Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU
To document any preliminary evidence of antitumor activity
Time Frame: Every 8 weeks
Every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

April 9, 2009

First Submitted That Met QC Criteria

April 9, 2009

First Posted (Estimate)

April 10, 2009

Study Record Updates

Last Update Posted (Estimate)

December 13, 2010

Last Update Submitted That Met QC Criteria

December 10, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1121003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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