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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
History of Changes

April 9, 2009
December 10, 2010
February 2007
March 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00879554 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
 
 
 
A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors
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.
 
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Solid Tumors
  • Neoplasms
  • Carcinoma
  • Cancer
  • Malignancy
Biological: CVX-045
Weekly, intravenous dose
Experimental: 1
Intervention: Biological: CVX-045
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2010
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00879554
B1121003
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP