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

Primary Purpose

Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NPI-2358
Sponsored by
Nereus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Solid Tumors, Lymphomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute/Wayne State University
  • Institute for Drug Development
  • Northwest Medical Specialties

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose escalation

Arm Description

Outcomes

Primary Outcome Measures

Safety
Tolerability
Maximum tolerated dose (MTD)

Secondary Outcome Measures

Pharmacokinetics
Pharmacodynamics
Response Evaluation Criteria in Solid Tumors (RECIST)

Full Information

First Posted
May 4, 2006
Last Updated
January 6, 2011
Sponsor
Nereus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00322608
Brief Title
Study of the Vascular Disrupting Agent NPI-2358 in Patients With Advanced Solid Tumors or Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nereus Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Solid Tumors, Lymphomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NPI-2358
Intervention Description
Treatment on Days 1, 8 and 15 in a 28 day cycle
Primary Outcome Measure Information:
Title
Safety
Time Frame
continuously
Title
Tolerability
Time Frame
continuously
Title
Maximum tolerated dose (MTD)
Time Frame
continuously
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
continuously
Title
Pharmacodynamics
Time Frame
continuously
Title
Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
continuously

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew A Spear, M.D.
Organizational Affiliation
Chief Medical Officer, Nereus Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute/Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Institute for Drug Development
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245-3217
Country
United States
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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