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Sponsored by: |
Nereus Pharmaceuticals, Inc. |
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Information provided by: | Nereus Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00630110 |
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 |
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Cancer |
Drug: docetaxel Drug: NPI-2358 + docetaxel |
Phase I Phase II |
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 |
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)
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NPI-2358 + docetaxel: Experimental
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
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Drug: NPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kristine C Federico, RN, BSN | 858-200-8352 | Kfederico@nereuspharm.com |
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 |
Study Director: | Matthew A Spear, MD | Chief Medical Officer, Nereus Pharmaceuticals, Inc |
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 |
Non Small Cell Lung |
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 |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |