Study of the Vascular Disrupting Agent NPI-2358 in Patients With Advanced Solid Tumors or Lymphoma
NCT00322608 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2011-01-10
Summary
This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the vascular disrupting agent NPI-2358 in patients with refractory solid tumors or lymphoma. The formation of new blood vessels (angiogenesis) is an important component of tumor growth and vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. NPI-2358 has also been seen to directly affect tumor cells.
Conditions
Interventions
- DRUG
-
NPI-2358
Treatment on Days 1, 8 and 15 in a 28 day cycle
Sponsors & Collaborators
-
Nereus Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Matthew A Spear, M.D. · Chief Medical Officer, Nereus Pharmaceuticals, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2009-09-30
- Completion
- 2009-12-31
Countries
- United States
Study Locations
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