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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322608
• Other study ID #: NPI-2358-100
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2006
• Last updated: January 6, 2011
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2011
• Source: Nereus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• NPI-2358
Treatment on Days 1, 8 and 15 in a 28 day cycle

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute/Wayne State University	Detroit	Michigan
United States	Institute for Drug Development	San Antonio	Texas
United States	Northwest Medical Specialties	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Nereus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		continuously	Yes
Primary	Tolerability		continuously	Yes
Primary	Maximum tolerated dose (MTD)		continuously	Yes
Secondary	Pharmacokinetics		continuously	No
Secondary	Pharmacodynamics		continuously	No
Secondary	Response Evaluation Criteria in Solid Tumors (RECIST)		continuously	No