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

Sponsor
Nereus Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00630110
Collaborator
(none)
172
Enrollment
36
Locations
2
Arms
40
Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358 [Continuous]

    Secondary Outcome Measures

    1. Compare response rate, duration of response, 6-month survival, progression free survival and safety. [Continuous]

    2. Pharmacokinetics [Continuous]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Scottsdale Arizona United States 85259
    2 San Diego Pacific Oncology & Hematology Associates Encinitas California United States 92024
    3 University San Diego Moores Cancer Center San Diego California United States 92093
    4 Kaiser Permanente San Diego California United States 92108
    5 Premiere Oncology Santa Monica California United States 90404
    6 Massachusetts General Hospital Boston Massachusetts United States 02114
    7 Karmanos Cancer Institute Detroit Michigan United States 48201
    8 University Texas Health Science Center at San Antonio (CTRC) San Antonio Texas United States 78229
    9 Policlinica Privada Instituto de Medicina Nuclear Bahia Blanca Argentina
    10 Hospital Britanico Capital Federal Argentina
    11 Instituto Oncologico De Cordoba Cordoba Argentina 5000 CRD
    12 Clinica Universitaria Privada Reina Fabiola Cordoba Argentina 5000CRD
    13 Caici Centro de Asistencia e Investigacion Clinica Integral Rosario Argentina
    14 Hospital del Centrenario Rosario Argentina
    15 Mater Adult Hospital South Brisbane Queensland Australia 4101
    16 Bendigo Health Care Group Bendigo Victoria Australia
    17 Sir Charles Gairdner Hospital Nedlands Western Australia Australia 6009
    18 Fundacap Pip XII Hospital do Cancer de Barretos Barretos Brazil
    19 Hospital Erasto Gaertner Liga do Combate as Cancer Curitiba Brazil
    20 Associacao Hospital de Caridade Ijui Ijui Brazil
    21 Hospital Sao Lucas Porte Alegre Brazil
    22 Hospital de clinicas de Porto Alegre Porto Alegre Brazil 90035
    23 Clinionco-Clinica de Oncologia de Porto Alegre Porto Alegre Brazil
    24 Hosp.das Clinicas da Univ.de Sao Paulo Sao Paulo Brazil
    25 Instituto do Cancer Aenaldo Vieira de Carvahlo Sao Paulo Brazil
    26 Instituto Nacional del Cancer Oncology Santiago Chile
    27 Hospital Carlos Van Buren Valparaiso Chile
    28 Chittaranjan National Cancer Institute Kolkata W. Bengal India 700026
    29 Kidwai Memorial Institute of Oncology Bangalore India 560029
    30 Apollo Speciality Hospital Chennai India 600035
    31 Apollo Hospital Hyderabad India 500033
    32 SEAROC Cancer Centre S.K. Soni Hospital Jaipur India 302013
    33 Subodh Mitra Cancer Hospital & Research Centre Kolkata India
    34 Tata Memorial Hospital Mumbai India 530002
    35 Ruby Hall Clinic Pune India 411011
    36 Andhra Medical College Vishakhapatnam India

    Sponsors and Collaborators

    • Nereus Pharmaceuticals, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00630110
    Other Study ID Numbers:
    • NPI-2358-101
    First Posted:
    Mar 6, 2008
    Last Update Posted:
    Aug 16, 2011
    Last Verified:
    Aug 1, 2011
    Keywords provided by , ,
    Non Small Cell Lung
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Docetaxel

    Study Results

    No Results Posted as of Aug 16, 2011