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Phase I Study of the Vascular Disrupting Agent NPI-2358 Administered Via Intravenous Infusion in Patients With Advanced Solid Tumor Malignancies or Lymphoma

Phase 1
18 Years
Not Enrolling

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Trial Information

Phase I Study of the Vascular Disrupting Agent NPI-2358 Administered Via Intravenous Infusion in Patients With Advanced Solid Tumor Malignancies or Lymphoma

Inclusion Criteria:

- 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 Criteria:

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:


Safety Issue:


Principal Investigator

Matthew A Spear, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Chief Medical Officer, Nereus Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

December 2009

Related Keywords:

  • Cancer
  • Solid Tumors
  • Lymphomas
  • Lymphoma



Institute for Drug DevelopmentSan Antonio, Texas  78245-3217
Northwest Medical SpecialtiesTacoma, Washington  98405
Barbara Ann Karmanos Cancer Institute/Wayne State UniversityDetroit, Michigan  48201