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

NCT ID: NCT00630110

Last Updated: 2011-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-06-30

Brief Summary

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.

Detailed Description

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).

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

docetaxel

docetaxel (75 mg/m2)

Group Type: ACTIVE_COMPARATOR

docetaxel

Intervention Type: DRUG

docetaxel (75 mg/m2)

NPI-2358 + docetaxel

NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)

Group Type: EXPERIMENTAL

NPI-2358 + docetaxel

Intervention Type: DRUG

NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)

Interventions

docetaxel

docetaxel (75 mg/m2)

Intervention Type: DRUG

NPI-2358 + docetaxel

NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)

Intervention Type: DRUG

Other Intervention Names

docetaxel (Taxotere); NPI-2358; docetaxel (Taxotere)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nereus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Nereus Pharmaceuticals, Inc.

Principal Investigators

Matthew A Spear, MD

Role: STUDY_DIRECTOR

Chief Medical Officer, Nereus Pharmaceuticals, Inc

Locations

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

Instituto Nacional del Cancer Oncology

Santiago, , Chile

Hospital Carlos Van Buren

Valparaíso, , Chile

Chittaranjan National Cancer Institute

Kolkata, West Bengal, India

Kidwai Memorial Institute of Oncology

Bangalore, , India

Apollo Speciality Hospital

Chennai, , India

Apollo Hospital

Hyderabad, , India

SEAROC Cancer Centre S.K. Soni Hospital

Jaipur, , India

Subodh Mitra Cancer Hospital & Research Centre

Kolkata, , India

Tata Memorial Hospital

Mumbai, , India

Ruby Hall Clinic

Pune, , India

Andhra Medical College

Visakhapatnam, , India

Countries

United States; Argentina; Australia; Brazil; Chile; India

Other Identifiers

NPI-2358-101

Identifier Type: -

Identifier Source: org_study_id