CVX-045-101: A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00879554

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

13.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors Neoplasms Carcinoma Cancer Malignancy	Biological: CVX-045	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: CVX-045 Weekly, intravenous dose

Arm

Intervention/Treatment

Experimental: 1

Biological: CVX-045

Weekly, intravenous dose

Outcome Measures

Primary Outcome Measures

To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors [Throughout duration of study]
To identify and characterize CVX-045-related adverse events (AEs) [Throughout duration of study]

Secondary Outcome Measures

To evaluate the plasma pharmacokinetics (PK) of CVX-045 [Days 1, 4, 8, 15, 29]
To determine a recommended Phase 2 dose of CVX-045 [End of study]
To evaluate the potential for immunogenicity of CVX-045 [Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU]
To document any preliminary evidence of antitumor activity [Every 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Scottsdale	Arizona	United States	85258
2	Pfizer Investigational Site	Santa Monica,	California	United States	90404
3	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19111