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

January 6, 2011 updated by: Nereus Pharmaceuticals, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute/Wayne State University
    • Texas
      • San Antonio, Texas, United States, 78245-3217
        • Institute for Drug Development
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: continuously
continuously
Tolerability
Time Frame: continuously
continuously
Maximum tolerated dose (MTD)
Time Frame: continuously
continuously

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: continuously
continuously
Pharmacodynamics
Time Frame: continuously
continuously
Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: continuously
continuously

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nereus Pharmaceuticals, Inc.

Investigators

  • Study Director: Matthew A Spear, M.D., Chief Medical Officer, Nereus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 4, 2006

First Submitted That Met QC Criteria

May 4, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

January 10, 2011

Last Update Submitted That Met QC Criteria

January 6, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPI-2358-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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