Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    35
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.
Study Started
Apr 30
2006
Primary Completion
Sep 30
2009
Study Completion
Dec 31
2009
Last Update
Jan 10
2011
Estimate

Drug NPI-2358

Treatment on Days 1, 8 and 15 in a 28 day cycle

Dose escalation Experimental

Criteria

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 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
No Results Posted