NCT00322608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Apr 2006

Typical duration for phase_1 cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 10, 2011

Status Verified

January 1, 2011

Enrollment Period

3.4 years

First QC Date

May 4, 2006

Last Update Submit

January 6, 2011

Conditions

Cancer

Keywords

Solid TumorsLymphomas

Outcome Measures

Primary Outcomes (3)

  • Safety

    continuously

  • Tolerability

    continuously

  • Maximum tolerated dose (MTD)

    continuously

Secondary Outcomes (3)

  • Pharmacokinetics

    continuously

  • Pharmacodynamics

    continuously

  • Response Evaluation Criteria in Solid Tumors (RECIST)

    continuously

Study Arms (1)

Dose escalation

EXPERIMENTAL
Drug: NPI-2358

Interventions

NPI-2358DRUG

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

Dose escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Barbara Ann Karmanos Cancer Institute/Wayne State University

Detroit, Michigan, 48201, United States

Location

Institute for Drug Development

San Antonio, Texas, 78245-3217, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

NeoplasmsLymphoma

Interventions

NPI 2358

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Matthew A Spear, M.D.

    Chief Medical Officer, Nereus Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 4, 2006

First Posted

May 8, 2006

Study Start

April 1, 2006

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

January 10, 2011

Record last verified: 2011-01

Locations

US(3)