|Canadian Cancer Trials Group IND.191 - A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma
Canadian Cancer Trials Group IND.191, a single arm phase II trial, was designed to explore the efficacy of AT9283 in patients with relapsed and refractory multiple myeloma.
Between February 2011 and July 2012, eight eligible patients were accrued and the trial was closed due to slow accrual and toxicity, in particular myelosuppression. Factors contributing to poor accrual in this trial for patients with multiple myeloma included the need for central venous catheter insertion for drug administration by 24-h infusion, a major inconvenience for patients and a resource-intensive approach for cancer treatment centers when out-patient oral or single injection subcutaneous therapy is now most commonplace. Patients considering participation in this trial would in many cases have had other active, more convenient and potentially well tolerated agents to consider as alternatives, either as standard therapy or in the context of clinical trials.
Among the eight patients enrolled, no objective responses were observed. While the limitations of this trial do not permit firm conclusions, AT9283 at this dose and schedule is not recommended for further study as a treatment for myeloma.
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