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

Pfizer

Status and phase: Completed; Phase 1

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

Treatments: Biological: CVX-045

Study type: Interventional

Funder types: Industry

Identifiers

NCT00879554

B1121003

Details and patient eligibility

About

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

Enrollment: 40 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

1

Experimental group

Treatment:

Biological: CVX-045