A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Advanced Solid TumorsNeoplasmsCarcinomaCancerMalignancy
- Interventions
- Biological: CVX-045
- Registration Number
- NCT00879554
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to determine safety and tolerability of CVX-045 in patients with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 CVX-045 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States