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
1 other identifier
interventional
172
6 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 cancer
Started Feb 2008
Typical duration for phase_1 cancer
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedAugust 16, 2011
August 1, 2011
3.3 years
February 26, 2008
August 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
Continuous
Secondary Outcomes (2)
Compare response rate, duration of response, 6-month survival, progression free survival and safety.
Continuous
Pharmacokinetics
Continuous
Study Arms (2)
docetaxel
ACTIVE COMPARATORdocetaxel (75 mg/m2)
NPI-2358 + docetaxel
EXPERIMENTALNPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
Interventions
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
San Diego Pacific Oncology & Hematology Associates
Encinitas, California, 92024, United States
University San Diego Moores Cancer Center
San Diego, California, 92093, United States
Kaiser Permanente
San Diego, California, 92108, United States
Premiere Oncology
Santa Monica, California, 90404, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
University Texas Health Science Center at San Antonio (CTRC)
San Antonio, Texas, 78229, United States
Policlinica Privada Instituto de Medicina Nuclear
Bahía Blanca, Argentina
Hospital Britanico
Capital Federal, Argentina
Instituto Oncologico De Cordoba
Córdoba, 5000 CRD, Argentina
Clinica Universitaria Privada Reina Fabiola
Córdoba, 5000CRD, Argentina
Caici Centro de Asistencia e Investigacion Clinica Integral
Rosario, Argentina
Hospital del Centrenario
Rosario, Argentina
Mater Adult Hospital
South Brisbane, Queensland, 4101, Australia
Bendigo Health Care Group
Bendigo, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, 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, 90035, 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, 700026, India
Kidwai Memorial Institute of Oncology
Bangalore, 560029, India
Apollo Speciality Hospital
Chennai, 600035, India
Apollo Hospital
Hyderabad, 500033, India
SEAROC Cancer Centre S.K. Soni Hospital
Jaipur, 302013, India
Subodh Mitra Cancer Hospital & Research Centre
Kolkata, India
Tata Memorial Hospital
Mumbai, 530002, India
Ruby Hall Clinic
Pune, 411011, India
Andhra Medical College
Visakhapatnam, India
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Matthew A Spear, MD
Chief Medical Officer, Nereus Pharmaceuticals, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 6, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 16, 2011
Record last verified: 2011-08