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

This study has been completed.
Sponsor:
Information provided by:
Nereus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00322608
First received: May 4, 2006
Last updated: January 6, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Cancer
Drug: NPI-2358
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nereus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
  • Tolerability [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose (MTD) [ Time Frame: continuously ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: continuously ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: continuously ] [ Designated as safety issue: No ]
  • Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: continuously ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose escalation Drug: NPI-2358
Treatment on Days 1, 8 and 15 in a 28 day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322608

Locations
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.
Investigators
Study Director: Matthew A Spear, M.D. Chief Medical Officer, Nereus Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Kristine C. Federico RN,BSN, Nereus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00322608     History of Changes
Other Study ID Numbers: NPI-2358-100
Study First Received: May 4, 2006
Last Updated: January 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Nereus Pharmaceuticals, Inc.:
Solid Tumors
Lymphomas

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 22, 2014