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Completed

NCT Number: NCT00879554

A Safety And Pharmacokinetic Study With CVX-045 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.

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Key information

Conditions

Advanced Solid Tumors Cancer Carcinoma Malignancy Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CVX-045

Biological

Weekly, intravenous dose

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: CVX-045-101

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Apr 10, 2009
Registry last updated
Dec 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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