In case of adverse events, are dose reductions or treatment delays allowed?
ASA404 must be administered on the same day as docetaxel. If a cycle delay is recommended for one therapy (either docetaxel or study drug), the remaining therapy must also be delayed until the toxicity resolves or returns to its baseline value. Any dose reduction or dose delay of the study drug is based upon the severity of toxicity, as graded by National Cancer Institute Clinical Toxicity Criteria (NCI-CTCAE, version 3.0). Once a dose has been reduced during a treatment cycle, re-escalation will not be permitted during any subsequent cycles. Patients requiring >1 dose reduction or a delay in study treatment >3 weeks will be discontinued from study treatment. If study treatment is stopped due to toxicity attributed specifically to docetaxel, the patient may continue to receive ASA404 as maintenance treatment.
