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Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer


This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with
docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new
blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting
agents are intended to target the differences between these tumor blood vessels and the
blood vessels in normal tissues. There are indications of advantages in combining vascular
disrupting agents with standard agents in the treatment of advanced non-small cell lung
cancer (NSCLC).


Inclusion Criteria:



- Male and females ≥ 18 years of age

- ECOG performance status ≤ 1

- Pathologically or histologically confirmed advanced non-small cell lung cancer
(unresectable Stage IIIb or IV) that has progressed after treatment with at least one
chemotherapy regimen; measurable disease is not required for enrollment into this
trial

- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have
resolved to Grade ≤ 2

- Signed informed consent

Exclusion Criteria:

- Administration of certain chemotherapy, biological, immunotherapy, radiation therapy,
surgery or investigational agent within specified time frames

- Significant cardiac history

- Prior treatment with tumor vascular disruptive agents

- Seizure disorder

- Brain metastases

- Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy

- Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or
C

- Patients with a prior hypersensitivity reaction to product components

- Pregnant or breast-feeding women.

- 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

- Unwilling or unable to comply with procedures required in this protocol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358

Outcome Time Frame:

Continuous

Safety Issue:

Yes

Principal Investigator

Matthew A Spear, MD

Investigator Role:

Study Director

Investigator Affiliation:

Chief Medical Officer, Nereus Pharmaceuticals, Inc

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

NPI-2358-101

NCT ID:

NCT00630110

Start Date:

February 2008

Completion Date:

June 2011

Related Keywords:

  • Cancer
  • Non Small Cell Lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617
Mayo ClinicScottsdale, Arizona  
Kaiser PermanenteSacramento, California  
Karmanos Cancer InstituteDetroit, Michigan  48201
Premiere OncologySanta Monica, California  90404
San Diego Pacific Oncology & Hematology AssociatesEncinitas, California  92024
University San Diego Moores Cancer CenterSan Diego, California  92093
University Texas Health Science Center at San Antonio (CTRC)San Antonio, Texas  78229