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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: docetaxel; Drug: NPI-2358 + docetaxel

• Registration Number: NCT00630110
• Lead Sponsor: Nereus Pharmaceuticals, Inc.

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).

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-15
• Last Update Posted: 2011-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358	Continuous

Secondary Outcome Measures

Name	Time	Method
Compare response rate, duration of response, 6-month survival, progression free survival and safety.	Continuous
Pharmacokinetics	Continuous

Trial Locations

Locations (36)

Hospital Britanico; 🇦🇷 Capital Federal, Argentina

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

Mater Adult Hospital; 🇦🇺 South Brisbane, Queensland, Australia

Policlinica Privada Instituto de Medicina Nuclear; 🇦🇷 Bahia Blanca, Argentina

Clinica Universitaria Privada Reina Fabiola; 🇦🇷 Cordoba, Argentina

Caici Centro de Asistencia e Investigacion Clinica Integral; 🇦🇷 Rosario, Argentina

Hospital Erasto Gaertner Liga do Combate as Cancer; 🇧🇷 Curitiba, Brazil

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Bendigo Health Care Group; 🇦🇺 Bendigo, Victoria, Australia

Instituto Oncologico De Cordoba; 🇦🇷 Cordoba, Argentina

Associacao Hospital de Caridade Ijui; 🇧🇷 Ijui, Brazil

Fundacap Pip XII Hospital do Cancer de Barretos; 🇧🇷 Barretos, Brazil

Apollo Hospital; 🇮🇳 Hyderabad, India

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Premiere Oncology; 🇺🇸 Santa Monica, California, United States

University Texas Health Science Center at San Antonio (CTRC); 🇺🇸 San Antonio, Texas, United States

Kaiser Permanente; 🇺🇸 San Diego, California, United States

University San Diego Moores Cancer Center; 🇺🇸 San Diego, California, United States

Hospital Sao Lucas; 🇧🇷 Porte Alegre, Brazil

Clinionco-Clinica de Oncologia de Porto Alegre; 🇧🇷 Porto Alegre, Brazil

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia

Hospital del Centrenario; 🇦🇷 Rosario, Argentina

Hospital de clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Brazil

Hosp.das Clinicas da Univ.de Sao Paulo; 🇧🇷 Sao Paulo, Brazil

Instituto do Cancer Aenaldo Vieira de Carvahlo; 🇧🇷 Sao Paulo, Brazil

Kidwai Memorial Institute of Oncology; 🇮🇳 Bangalore, India

Hospital Carlos Van Buren; 🇨🇱 Valparaiso, Chile

Instituto Nacional del Cancer Oncology; 🇨🇱 Santiago, Chile

Chittaranjan National Cancer Institute; 🇮🇳 Kolkata, W. Bengal, India

Apollo Speciality Hospital; 🇮🇳 Chennai, India

SEAROC Cancer Centre S.K. Soni Hospital; 🇮🇳 Jaipur, India

Subodh Mitra Cancer Hospital & Research Centre; 🇮🇳 Kolkata, India

Tata Memorial Hospital; 🇮🇳 Mumbai, India

Andhra Medical College; 🇮🇳 Vishakhapatnam, India

San Diego Pacific Oncology & Hematology Associates; 🇺🇸 Encinitas, California, United States

Ruby Hall Clinic; 🇮🇳 Pune, India