Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Completed · Phase 1/Phase 2

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT00630110

Run by

Nereus Pharmaceuticals, Inc.

People needed

172

Starts

2008-02-01

Expected to finish

2011-06-01

Last updated by the study team

2011-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• San Diego Pacific Oncology & Hematology Associates — Encinitas, California, United States
• University San Diego Moores Cancer Center — San Diego, California, United States
• Kaiser Permanente — San Diego, California, United States
• Premiere Oncology — Santa Monica, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• University Texas Health Science Center at San Antonio (CTRC) — San Antonio, Texas, United States
• Policlinica Privada Instituto de Medicina Nuclear — Bahía Blanca, Argentina
• Hospital Britanico — Capital Federal, Argentina
• Instituto Oncologico De Cordoba — Córdoba, Argentina
• Clinica Universitaria Privada Reina Fabiola — Córdoba, Argentina
• Caici Centro de Asistencia e Investigacion Clinica Integral — Rosario, Argentina
• Hospital del Centrenario — Rosario, Argentina
• Mater Adult Hospital — South Brisbane, Queensland, Australia
• Bendigo Health Care Group — Bendigo, Victoria, Australia
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
• Fundacap Pip XII Hospital do Cancer de Barretos — Barretos, Brazil
• Hospital Erasto Gaertner Liga do Combate as Cancer — Curitiba, Brazil
• Associacao Hospital de Caridade Ijui — Ijuí, Brazil
• Hospital Sao Lucas — Porte Alegre, Brazil
• Hospital de clinicas de Porto Alegre — Porto Alegre, Brazil
• Clinionco-Clinica de Oncologia de Porto Alegre — Porto Alegre, Brazil
• Hosp.das Clinicas da Univ.de Sao Paulo — São Paulo, Brazil
• Instituto do Cancer Aenaldo Vieira de Carvahlo — São Paulo, Brazil

Full record on ClinicalTrials.gov

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