Status:
COMPLETED
Study of the Vascular Disrupting Agent NPI-2358 in Patients With Advanced Solid Tumors or Lymphoma
Lead Sponsor:
Nereus Pharmaceuticals, Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 l...
Eligibility Criteria
Inclusion
- ECOG performance status ≤ 2
- Pathologically or histologically confirmed solid tumor malignancy
- Patients must not be candidates for regimens known to provide clinical benefit.
- All adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (v. 3.0) Grade ≤ 2, except for neurological toxicity that must have resolved to Grade ≤ 1.
- Adequate bone marrow reserve, hepatic and renal function
- Signed informed consent
Exclusion
- Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 21 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin C; 12 weeks for radioimmunotherapy). Major surgery, other than diagnostic surgery, within 6 weeks before first study drug administration. Radiotherapy within 4 weeks (some types of radiation therapy are excluded regardless of interval since treatment).
- Significant cardiac history or findings
- Underlying conditions or medications associated with bleeding diathesis
- Disorders associated with significant vascular pathology
- Lung cancer with central chest tumors
- Prior treatment with vascular disruptive agents
- Seizure disorder requiring anticonvulsant therapy; prior transient ischemic attack or cerebrovascular accident
- Brain metastases
- Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
- Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
- Known infection with human immunodeficiency virus (HIV), active hepatitis A, B, or C
- Patients with a prior hypersensitivity reaction to any product containing Solutol and/or propylene glycol
- Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. Female patients with childbearing potential must have a negative serum pregnancy test. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
- Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00322608
Start Date
April 1 2006
End Date
December 1 2009
Last Update
January 10 2011
Active Locations (3)
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1
Barbara Ann Karmanos Cancer Institute/Wayne State University
Detroit, Michigan, United States, 48201
2
Institute for Drug Development
San Antonio, Texas, United States, 78245-3217
3
Northwest Medical Specialties
Tacoma, Washington, United States, 98405