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

Cancer Clinical Trial

Official title:

Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630110
• Other study ID #: NPI-2358-101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 26, 2008
• Last updated: August 15, 2011
• Start date: February 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Nereus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Food and Drug AdministrationIndia: Drugs Controller General of IndiaChile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• docetaxel
docetaxel (75 mg/m2)
• NPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)

Locations

Country	Name	City	State
Argentina	Policlinica Privada Instituto de Medicina Nuclear	Bahia Blanca
Argentina	Hospital Britanico	Capital Federal
Argentina	Clinica Universitaria Privada Reina Fabiola	Cordoba
Argentina	Instituto Oncologico De Cordoba	Cordoba
Argentina	Caici Centro de Asistencia e Investigacion Clinica Integral	Rosario
Argentina	Hospital del Centrenario	Rosario
Australia	Bendigo Health Care Group	Bendigo	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Mater Adult Hospital	South Brisbane	Queensland
Brazil	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	Clinionco-Clinica de Oncologia de Porto Alegre	Porto Alegre
Brazil	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
Chile	Instituto Nacional del Cancer Oncology	Santiago
Chile	Hospital Carlos Van Buren	Valparaiso
India	Kidwai Memorial Institute of Oncology	Bangalore
India	Apollo Speciality Hospital	Chennai
India	Apollo Hospital	Hyderabad
India	SEAROC Cancer Centre S.K. Soni Hospital	Jaipur
India	Chittaranjan National Cancer Institute	Kolkata	W. Bengal
India	Subodh Mitra Cancer Hospital & Research Centre	Kolkata
India	Tata Memorial Hospital	Mumbai
India	Ruby Hall Clinic	Pune
India	Andhra Medical College	Vishakhapatnam
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	San Diego Pacific Oncology & Hematology Associates	Encinitas	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	Premiere Oncology	Santa Monica	California
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Nereus Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Chile,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358		Continuous	Yes
Secondary	Compare response rate, duration of response, 6-month survival, progression free survival and safety.		Continuous	Yes
Secondary	Pharmacokinetics		Continuous	No