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NCT00879554 Clinical Trial

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

Cancer Clinical Trial

— CVX-045-101  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00879554
Other study ID # B1121003
Secondary ID
Status Completed
Phase Phase 1
First received April 9, 2009
Last updated December 10, 2010
Start date February 2007
Est. completion date November 2010

Study information
Verified date December 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date November 2010
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• CVX-045
Weekly, intravenous dose

Locations
Country Name City State
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Santa Monica, California
United States Pfizer Investigational Site Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors Throughout duration of study Yes
Primary To identify and characterize CVX-045-related adverse events (AEs) Throughout duration of study Yes
Secondary To evaluate the plasma pharmacokinetics (PK) of CVX-045 Days 1, 4, 8, 15, 29 No
Secondary To determine a recommended Phase 2 dose of CVX-045 End of study No
Secondary To evaluate the potential for immunogenicity of CVX-045 Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU Yes
Secondary To document any preliminary evidence of antitumor activity Every 8 weeks No
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