Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00879554
Previous Study | Return to List | Next Study

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
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 9, 2009
First Posted Date  ICMJE April 10, 2009
Last Update Posted Date December 13, 2010
Study Start Date  ICMJE February 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2009)
  • 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 ]
  • To identify and characterize CVX-045-related adverse events (AEs) [ Time Frame: Throughout duration of study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2009)
  • To evaluate the plasma pharmacokinetics (PK) of CVX-045 [ Time Frame: Days 1, 4, 8, 15, 29 ]
  • To determine a recommended Phase 2 dose of CVX-045 [ Time Frame: 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 ]
  • To document any preliminary evidence of antitumor activity [ Time Frame: Every 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors
Official Title  ICMJE 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
Brief Summary The purpose of the study is to determine safety and tolerability of CVX-045 in patients with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumors
  • Neoplasms
  • Carcinoma
  • Cancer
  • Malignancy
Intervention  ICMJE Biological: CVX-045
Weekly, intravenous dose
Study Arms  ICMJE Experimental: 1
Intervention: Biological: CVX-045
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2009)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00879554
Other Study ID Numbers  ICMJE B1121003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2010

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