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A Multicenter, Open-Label, 2-Stage, Phase 1, Clinical Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-045, A Thrombospondin-1 Mimetic, Anti-Angiogenic Agent, In Patients With Advanced Solid Tumors


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

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Trial Information

A Multicenter, Open-Label, 2-Stage, Phase 1, Clinical Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-045, A Thrombospondin-1 Mimetic, Anti-Angiogenic Agent, 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 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.

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-045 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:

B1121003

NCT ID:

NCT00879554

Start Date:

February 2007

Completion Date:

November 2010

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms
  • Carcinoma
  • Cancer
  • Malignancy
  • Phase 1
  • Solid Tumors
  • CVX-045
  • Neoplasms
  • Carcinoma

Name

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