Trial Information

Summary: Protocol C2006-01 - A Phase III, Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi™ for the Prevention of Acute- Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following the Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens.

Condition: Chemotherapy Induced Nausea and Vomiting

Phase: III

Recruiting Status: Currently Active

Sponsor: A. P. Pharma

Study Description: The purpose of this study is to demonstrate how effective the new formulation of granisetron is when compared to Aloxi™ Also to monitor the safety of APF530 and it’s effectiveness in controlling nausea and vomiting over multiple courses of highly emetic chemotherapy.

Inclusion Criteria: Men and women 18 years or older currently receiving moderately or highly emetogenic chemotherapy which causes emesis in 30% – 100% of patients.

Exclusion Criteria: Medications (also C4P3A4 Inhibitors) not to be used during study: EMEND, Kytril, Aloxi™ Women who are pregnant, breast feeding or trying to conceive and patients with protocol deviations deemed to have a significant impact on efficacy variables will be excluded.

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Trial listings updated: June 1, 2008 at 5:45:58 AM