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

Sponsored by:	Nereus Pharmaceuticals, Inc.
Information provided by:	Nereus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00630110

Purpose

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	Intervention	Phase
Cancer	Drug: docetaxel Drug: NPI-2358 + docetaxel	Phase I Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Further study details as provided by Nereus Pharmaceuticals, Inc.:

Primary Outcome Measures:

Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358 [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Compare response rate, duration of response, 6-month survival, progression free survival and safety. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
Pharmacokinetics [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Estimated Enrollment:	174
Study Start Date:	February 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
docetaxel: Active Comparator docetaxel (75 mg/m2)	Drug: docetaxel docetaxel (75 mg/m2)
NPI-2358 + docetaxel: Experimental NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)	Drug: NPI-2358 + docetaxel NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Patients requiring therapeutic anticoagulation
Seizure disorder
Brain metastases
History of bleeding or vascular disorder
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630110

Contacts

Contact: Kristine C Federico, RN, BSN

858-200-8352

Kfederico@nereuspharm.com

Locations

United States, California
San Diego Pacific Oncology & Hematology Associates	Recruiting
Encinitas, California, United States, 92024
Contact: Karen Brady, RN, MSN 760-452-3340 kbrady@pacificoncology.com
Principal Investigator: Edward McClay, MD
Premiere Oncology	Recruiting
Santa Monica, California, United States, 90404
Contact: Marilyn Mulay, RNP 310-633-8400 mmulay@premiereoncology.com
Principal Investigator: Lee Rosen, MD
United States, Michigan
Karmanos Caner Institute	Recruiting
Detroit, Michigan, United States, 48201
Contact: Karen Dziubek, BS 313-576-9364 dziubekk@karmanos.org
Contact: , BS
Principal Investigator: Shirish M Gadgeel, MD
United States, Texas
University Texas Health Science Center at San Antonio (CTRC)	Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Ofelia Romero, RN 210-450-1810 romeroo@uthscsa.edu
Principal Investigator: Alain C Mita, MD
Australia, Queensland
Mater Adult Hospital	Not yet recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Ken Musgrave 61-7-3840-8697 Ken.musgrave@mater.org.au
Principal Investigator: Paul Mainwaring, Professor,MD
Australia, Western Australia
Sir Charles Gairdner Hospital	Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Judy Innes-Rowe, RN 61-8-9346-4520 judy.innes-rowe@health.wa.gov.au
Principal Investigator: Michael Millward, Professor,MD

Sponsors and Collaborators

Nereus Pharmaceuticals, Inc.

Investigators

Study Director:

Matthew A Spear, MD

Chief Medical Officer, Nereus Pharmaceuticals, Inc

More Information

Responsible Party:	Nereus Pharmaceuticals, Inc. ( Kristine Federico, RN BSN - Clinical Trial Manager )
Study ID Numbers:	NPI-2358-101
Study First Received:	February 26, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00630110
Health Authority:	Australia: Therapeutic Goods Administration (TGA); United States: Food and Drug Administration

Keywords provided by Nereus Pharmaceuticals, Inc.:

Non Small Cell Lung

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009