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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasms; Advanced Solid Tumors; Carcinoma; Cancer; Malignancy

Treatments: Biological: CVX-060

Study type: Interventional

Funder types: Industry

Identifiers

NCT00879684

B1131002

CVX-060-101 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

1

Experimental group

Treatment:

Biological: CVX-060