CompletedNCT00630110Updated Aug 16, 2011

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

A Phase 1/2 interventional study of docetaxel and NPI-2358 + docetaxel in Cancer, sponsored by Nereus Pharmaceuticals, Inc.. Completed at 36 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-16.

Sponsored by Nereus Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 172
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

Conditions studied

Cancer

Browse trials for

Carcinoma, Non-Small-Cell Lung 6,488

Keywords

Non Small Cell Lung

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 172 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Nereus Pharmaceuticals, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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 design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 172 participants (actual)

Study arms

Active comparator
docetaxel
docetaxel (75 mg/m2)
Drug: docetaxel
Experimental
NPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
Drug: NPI-2358 + docetaxel

Interventions

Drugdocetaxel
docetaxel (75 mg/m2)
Also known as: docetaxel (Taxotere)
DrugNPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
Also known as: NPI-2358; docetaxel (Taxotere)

What researchers measure

Primary outcomes

Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
Time frame: Continuous

Secondary outcomes

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

Study locations

36 sites

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
Bahia Blanca, Argentina
Hospital Britanico
Capital Federal, Argentina
Instituto Oncologico De Cordoba
Cordoba, 5000 CRD, Argentina
Clinica Universitaria Privada Reina Fabiola
Cordoba, 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
Ijui, 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
Sao Paulo, Brazil
Instituto do Cancer Aenaldo Vieira de Carvahlo
Sao Paulo, Brazil
Instituto Nacional del Cancer Oncology
Santiago, Chile
Hospital Carlos Van Buren
Valparaiso, Chile
Chittaranjan National Cancer Institute
Kolkata, W. 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
Vishakhapatnam, India

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00630110
Lead sponsor: Nereus Pharmaceuticals, Inc.
First posted: Mar 6, 2008
Start date: Feb 2008
Primary completion: Jun 2011
Completion: Jun 2011
Last update: Aug 16, 2011

Study contacts

Matthew A Spear, MD

study director · Chief Medical Officer, Nereus Pharmaceuticals, Inc

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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