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

Phase 1CompletedNCT00879554

Pfizer40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors Neoplasms Carcinoma Cancer Malignancy

Interventions

CVX-045BIOLOGICAL

Weekly, intravenous dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Pfizer Investigational Site

Scottsdale, Arizona, United States

Pfizer Investigational Site

Santa Monica, California, United States

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

To identify and characterize CVX-045-related adverse events (AEs)

Time frame: Throughout duration of study

Secondary Outcomes

To evaluate the plasma pharmacokinetics (PK) of CVX-045

Time frame: Days 1, 4, 8, 15, 29

To determine a recommended Phase 2 dose of CVX-045

Time frame: End of study

To evaluate the potential for immunogenicity of CVX-045

Time frame: Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU

To document any preliminary evidence of antitumor activity

Time frame: Every 8 weeks

Data from ClinicalTrials.gov

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