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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00879554
Recruitment Status : Completed
First Posted : April 10, 2009
Last Update Posted : December 13, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Neoplasms Carcinoma Cancer Malignancy Biological: CVX-045 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2007
Primary Completion Date : March 2009
Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: 1 Biological: CVX-045
Weekly, intravenous dose

Primary Outcome Measures :
  1. 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 ]
  2. To identify and characterize CVX-045-related adverse events (AEs) [ Time Frame: Throughout duration of study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879554

United States, Arizona
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85258
United States, California
Pfizer Investigational Site
Santa Monica,, California, United States, 90404
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00879554     History of Changes
Other Study ID Numbers: B1121003
First Posted: April 10, 2009    Key Record Dates
Last Update Posted: December 13, 2010
Last Verified: December 2010

Keywords provided by Pfizer:
Phase 1
Solid Tumors