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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00879554
First received: April 9, 2009
Last updated: December 10, 2010
Last verified: December 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To identify and characterize CVX-045-related adverse events (AEs) [ Time Frame: Throughout duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the plasma pharmacokinetics (PK) of CVX-045 [ Time Frame: Days 1, 4, 8, 15, 29 ] [ Designated as safety issue: No ]
  • To determine a recommended Phase 2 dose of CVX-045 [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To evaluate the potential for immunogenicity of CVX-045 [ Time Frame: Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU ] [ Designated as safety issue: Yes ]
  • To document any preliminary evidence of antitumor activity [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2007
Study Completion Date: November 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: CVX-045
Weekly, intravenous dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879554

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00879554     History of Changes
Other Study ID Numbers: B1121003
Study First Received: April 9, 2009
Last Updated: December 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
Solid Tumors
CVX-045

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014