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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: NPI-2358 + docetaxel

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 Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Argentina
  • Bahia Blanca, Argentina
    • Policlínica Privada Instituto de Medicina Nuclear
  • Capital Federal, Argentina
    • Hospital Britanico
  • Cordoba, Argentina, 5000 CRD
    • Instituto Oncologico de Cordoba
  • Cordoba, Argentina, 5000CRD
    • Clinica Universitaria Privada Reina Fabiola
  • Rosario, Argentina
    • Caici Centro de Asistencia e Investigacion Clinica Integral
  • Rosario, Argentina
    • Hospital del Centrenario
• Australia
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Adult Hospital
  • Victoria
    • Bendigo, Victoria, Australia
      • Bendigo Health Care Group
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Brazil
  • Barretos, Brazil
    • Fundacap Pip XII Hospital do Cancer de Barretos
  • Curitiba, Brazil
    • Hospital Erasto Gaertner Liga do Combate as Cancer
  • Ijui, Brazil
    • Associacao Hospital de Caridade Ijui
  • Porte Alegre, Brazil
    • Hospital São Lucas
  • Porto Alegre, Brazil, 90035
    • Hospital de Clinicas de Porto Alegre
  • Porto Alegre, Brazil
    • Clinionco-Clinica de Oncologia de Porto Alegre
  • Sao Paulo, Brazil
    • Hosp.das Clinicas da Univ.de Sao Paulo
  • Sao Paulo, Brazil
    • Instituto do Cancer Aenaldo Vieira de Carvahlo
• Chile
  • Santiago, Chile
    • Instituto Nacional del Cancer Oncology
  • Valparaiso, Chile
    • Hospital Carlos Van Buren
• India
  • Bangalore, India, 560029
    • Kidwai Memorial Institute of Oncology
  • Chennai, India, 600035
    • Apollo Speciality Hospital
  • Hyderabad, India, 500033
    • Apollo Hospital
  • Jaipur, India, 302013
    • SEAROC Cancer Centre S.K. Soni Hospital
  • Kolkata, India
    • Subodh Mitra Cancer Hospital & Research Centre
  • Mumbai, India, 530002
    • Tata Memorial Hospital
  • Pune, India, 411011
    • Ruby Hall Clinic
  • Vishakhapatnam, India
    • Andhra Medical College
  • W. Bengal
    • Kolkata, W. Bengal, India, 700026
      • Chittaranjan National Cancer Institute
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic
  • California
    • Encinitas, California, United States, 92024
      • San Diego Pacific Oncology & Hematology Associates
    • San Diego, California, United States, 92108
      • Kaiser Permanente
    • San Diego, California, United States, 92093
      • University San Diego Moores Cancer Center
    • Santa Monica, California, United States, 90404
      • Premiere Oncology
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Texas
    • San Antonio, Texas, United States, 78229
      • University Texas Health Science Center at San Antonio (CTRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: docetaxel; docetaxel (75 mg/m2)	Drug: docetaxel; docetaxel (75 mg/m2); Other Names: docetaxel (Taxotere)
Experimental: NPI-2358 + docetaxel; NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)	Drug: NPI-2358 + docetaxel; NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2); Other Names: NPI-2358; docetaxel (Taxotere)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358	Continuous

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	Continuous
Compare response rate, duration of response, 6-month survival, progression free survival and safety.	Continuous

Collaborators and Investigators

• Sponsor: Nereus Pharmaceuticals, Inc.
• Investigators: Study Director: Matthew A Spear, MD, Chief Medical Officer, Nereus Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 26, 2008
• First Submitted That Met QC Criteria: March 5, 2008
• First Posted (Estimate): March 6, 2008

Study Record Updates

• Last Update Posted (Estimate): August 16, 2011
• Last Update Submitted That Met QC Criteria: August 15, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Non Small Cell Lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: NPI-2358-101