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Study of the Vascular Disrupting Agent NPI-2358 in Patients With Advanced Solid Tumors or Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00322608
Recruitment Status : Completed
First Posted : May 8, 2006
Last Update Posted : January 10, 2011
Information provided by:
Nereus Pharmaceuticals, Inc.

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 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.

Condition or disease Intervention/treatment Phase
Cancer Drug: NPI-2358 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of the Vascular Disrupting Agent NPI-2358 Administered Via Intravenous Infusion in Patients With Advanced Solid Tumor Malignancies or Lymphoma
Study Start Date : April 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Dose escalation Drug: NPI-2358
Treatment on Days 1, 8 and 15 in a 28 day cycle

Primary Outcome Measures :
  1. Safety [ Time Frame: continuously ]
  2. Tolerability [ Time Frame: continuously ]
  3. Maximum tolerated dose (MTD) [ Time Frame: continuously ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: continuously ]
  2. Pharmacodynamics [ Time Frame: continuously ]
  3. Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: continuously ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00322608

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United States, Michigan
Barbara Ann Karmanos Cancer Institute/Wayne State University
Detroit, Michigan, United States, 48201
United States, Texas
Institute for Drug Development
San Antonio, Texas, United States, 78245-3217
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Nereus Pharmaceuticals, Inc.
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Study Director: Matthew A Spear, M.D. Chief Medical Officer, Nereus Pharmaceuticals, Inc.
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Responsible Party: Kristine C. Federico RN,BSN, Nereus Pharmaceuticals, Inc. Identifier: NCT00322608    
Other Study ID Numbers: NPI-2358-100
First Posted: May 8, 2006    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: January 2011
Keywords provided by Nereus Pharmaceuticals, Inc.:
Solid Tumors
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases