Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors - Full Text View

Purpose

The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.

Condition	Intervention	Phase
Advanced Solid Tumors Neoplasms Carcinoma Cancer Malignancy	Biological: CVX-060	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of CVX-060, A Selective Angiopoietin-2 (ANG-2) Binding, Anti-Angiogenic COVX-Body, In Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine safety and tolerability of CVX-060 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors [ Time Frame: Throughout duration of study ] [ Designated as safety issue: Yes ]
To identify and characterize CVX-060-related adverse events (AEs) [ Time Frame: Throughout duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the plasma pharmacokinetics (PK) of CVX-060 [ Time Frame: Days 0, 4, 7, 14, 28 ] [ Designated as safety issue: Yes ]
To determine a recommended Phase 2 dose of CVX-060 [ Time Frame: End of study ] [ Designated as safety issue: No ]
To evaluate the potential for immunogenicity of CVX-060 [ Time Frame: Day 0, 14, 1st day of each cycle, EOS, 42 Day FU ] [ Designated as safety issue: Yes ]
To document any preliminary evidence of antitumor activity [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	34
Study Start Date:	January 2008
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Biological: CVX-060 Weekly, intravenous dose

Eligibility

Criteria

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 evaluations.
ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

Exclusion Criteria:

Evidence of significant bleeding problems.
History of certain gastrointestinal problems including fistula and abscess.
Chronic, uncontrolled hypertension.
Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879684

Locations

United States, Arizona
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85258
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85255
United States, California
Pfizer Investigational Site
Santa Monica,, California, United States, 90404
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00879684 History of Changes
Other Study ID Numbers:	B1131002, CVX-060-101
Study First Received:	April 9, 2009
Last Updated:	May 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Phase 1
Tumors
CVX-060

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 16, 2013