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CompletedNCT00879554CVX-045-101Updated Dec 13, 2010

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

A Phase 1 interventional study of CVX-045 in Advanced Solid Tumors, Neoplasms and Carcinoma, sponsored by Pfizer. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-13.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Advanced Solid Tumors
  • Neoplasms
  • Carcinoma
  • Cancer
  • Malignancy

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Keywords

  • Phase 1
  • Solid Tumors
  • CVX-045
03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 581 completed or terminated interventional studies of FDA-regulated products, 380 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Evidence of bleeding problems.
  • Uncontrolled hypertension.
  • Certain gastrointestinal problems including fistula and abscess.
  • Patients with primary brain cancer.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    1

    Biological: CVX-045

Interventions

  • BiologicalCVX-045

    Weekly, intravenous dose

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

3 sites
  • Pfizer Investigational Site
    Scottsdale, Arizona 85258, United States
  • Pfizer Investigational Site
    Santa Monica,, California 90404, United States
  • Pfizer Investigational Site
    Philadelphia, Pennsylvania 19111, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00879554
Lead sponsor
Pfizer
First posted
Apr 10, 2009
Start date
Feb 2007
Primary completion
Mar 2009
Completion
Nov 2010
Last update
Dec 13, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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