Text Size

Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00879684
First received: April 9, 2009
Last updated: May 12, 2011
Last verified: May 2011
History of Changes

April 9, 2009
May 12, 2011
January 2008
April 2011   (final data collection date for primary outcome measure)
  • To determine safety and tolerability of CVX-060 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-060-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 NCT00879684 on ClinicalTrials.gov Archive Site
  • To evaluate the plasma pharmacokinetics (PK) of CVX-060 [ Time Frame: Days 0, 4, 7, 14, 28 ] [ Designated as safety issue: Yes ]
  • To determine a recommended Phase 2 dose of CVX-060 [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To evaluate the potential for immunogenicity of CVX-060 [ Time Frame: Day 0, 14, 1st day of each cycle, EOS, 42 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 ]
Same as current
 
 
 
Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of CVX-060, A Selective Angiopoietin-2 (ANG-2) Binding, Anti-Angiogenic COVX-Body, In Patients With Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability of CVX-060 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-060
Weekly, intravenous dose
Experimental: 1
Intervention: Biological: CVX-060
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
April 2011
April 2011   (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 evaluations.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

Exclusion Criteria:

  • Evidence of significant bleeding problems.
  • History of certain gastrointestinal problems including fistula and abscess.
  • Chronic, uncontrolled hypertension.
  • Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00879684
B1131002, CVX-060-101
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

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