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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, Malignancy

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine safety and tolerability of CVX-060 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors

Outcome Time Frame:

Throughout duration of study

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1131002

NCT ID:

NCT00879684

Start Date:

January 2008

Completion Date:

April 2011

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms
  • Carcinoma
  • Cancer
  • Malignancy
  • Phase 1
  • Tumors
  • CVX-060
  • Neoplasms
  • Carcinoma

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535