ATTRACT | ATTRACT-1 Study | Researching ASA404 In Cancer Treatment
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ATTRACT–1

March 25, 2010 Update:
We would like to inform you that the Data Monitoring Committee (DMC) for the ATTRACT-1 trial (CASA404A2301) met on 25 March 2010 for an Interim Analysis. The Committee has recommended stopping the study for futility as there was no prospect of demonstrating a survival benefit with the addition of ASA404 in this setting. Therefore, in compliance with this recommendation the ATTRACT-1 trial will be halted.
No new or unexpected serious adverse effects of ASA404 have been identified by the trial’s Data Monitoring Committee. The interim results confirms the safety profile already known for the drug. The safety profile of the drug is not considered to preclude ongoing investigations in other settings.
The recommendation from both ATTRACT-1 and ATTRACT-2 Study Steering Committee members is to continue enrollment into ATTRACT-2.
The rationale for continuation includes:
  • No safety concerns related to ASA404 were observed.
  • ATTRACT-2 trial focuses on a different patient population with a poor prognosis and different comparator drug.
  • All patients are receiving 2nd line standard of care therapy.
  • The ATTRACT-2 planned Interim Analysis by the independent DMC is expected to occur later in the second half of 2010.
ATTRACT-1 (Antivascular Targeted Therapy: Researching ASA404 in Cancer Treatment) is a Phase III clinical trial which is conducted at more than 200 sites in 20 countries. ATTRACT-1 is a randomized, double-blind, placebo-controlled, multi-center study of ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC) of squamous or nonsquamous histology. The clinical trial consists of 1,200 lung cancer patients who are assigned to one of the following cancer treatment arms in a ratio of 1:1: ASA404 1800 mg/m2 plus chemotherapy (carboplatin/paclitaxel) or placebo plus chemotherapy (carboplatin/paclitaxel) as a control. Cancer treatment is being given for up to six cycles, with one cycle equaling 21 days and total treatment equaling 126 days (4.2 months).