Antisoma's Partner Novartis Initiates Phase III Trial of Lung Cancer Drug
Posted on: Friday, 11 April 2008, 12:00 CDT
Antisoma has announced that its partner Novartis has started the pivotal Phase III trial of ASA404 combined with first-line chemotherapy in non-small cell lung cancer.
The Attract-1 trial is a randomized, double-blind, placebo-controlled, multicentre Phase III trial being conducted across the US, EU and other territories. With 1200 patients, it will be amongst the largest trials conducted in non-small cell lung cancer (NSCLC).
Attract-1 is open to patients with all histologies, or types, of NSCLC, including squamous and non-squamous cancers. Patients are being randomized 1:1 to receive either ASA404 1800 mg/m2 plus chemotherapy (carboplatin/paclitaxel) or a placebo plus chemotherapy (carboplatin/paclitaxel) as a control. The primary endpoint of the Attract-1 trial is overall survival. Key secondary endpoints are survival in the squamous and non-squamous patient subgroups.
The Attract-1 study is designed to support applications for marketing authorizations in the US, Europe and other territories. Its initiation triggers a $25 million milestone payment to Antisoma. If the trial results are positive, applications for marketing authorizations are anticipated in 2011. There will be a single scheduled interim look during the trial, expected in mid-late 2009.
Source: Datamonitor
Related Articles
- Independent Data Monitoring Committee Recommends Resuming Enrollment of Non-Squamous NSCLC Patients in the Motesanib MONET1 Trial
- Molecular Insight Initiates Phase IIa Azedra Trial in Neuroblastoma Patients
- Molecular Insight Pharmaceuticals, Inc. Initiates Phase 2a Azedra(TM) Clinical Trial in Neuroblastoma Patients
- Speedel Announces Start of Spp635 Phase Iia Trial in Diabetic Patients
- Norwood Abbey Announces Phase II Clinical Trial in Cancer Patients Commences
- Somaxon Pharmaceuticals, Inc. Initiates Second Phase III Clinical Trial of SILENOR(TM) -- Product Will Be Evaluated in Long-Term Trial of Elderly Patients With Primary Chronic Insomnia
- CVBT Announces It Will Begin U.S. FDA-Authorized Clinical Trials in Diabetic Patients With Open Wounds
- Predix Pharmaceuticals Announces Initiation of Phase Ib Clinical Trial in Alzheimer's Patients; Provides Initial Dose Study Update
- Interim Analysis of Phase III Trial Shows Avastin Plus Chemotherapy Extends Survival of Patients With First-Line Non-Squamous, Non-Small Cell Lung Cancer
- Phase 3 Trial of Genasense(R) Plus Chemotherapy in Patients With Advanced Chronic Lymphocytic Leukemia Achieves Primary Endpoint
 |
 |
User Comments (0)
RSS Feeds