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Traditionally, clinical trials for oncology have been designed to evaluate treatments in patients with a particular tumor type, e.g. breast cancer, lung cancer, etc. This design can be challenging when evaluating targeted therapies that are tailored to a subpopulation of patients with a specific mutation. In particular, if only a small fraction of patients across various cancer types have the mutation targeted by the treatment, then it may be more difficult to fully enroll a clinical trial with patients of a single cancer type that have the mutation of interest. The ‘basket’ trial is an emerging design aimed at overcoming this challenge. In a ‘basket’ trial, patients are preselected based on molecular features of their tumor, generally irrespective of the tumor type. Efficacy is evaluated in patients selected based on biomarkers known to be predictive of potential effectiveness, and thus these trials are potentially better at detecting an efficacy signal than a traditionally designed trial would be.

 

This trial design originated from the Imatinib B2225 study [1] which looked at the efficacy of imatinib in treating patients with malignancies expressing imatinib-sensitive tyrosine kinases. Imatinib B2225 completed in early 2006, and the data from this phase II trial was used to gain approval of imatinib in four additional indications (Imatinib was initially approved for chronic myeloid leukemia during the course of the trial). Since the successful completion of Imatinib B2225 study, there has been an increasing interest in basket trials (see recent reviews [2] and [3]). More than half of all identified basket trials started in the past three years, suggesting an increasing trend in the number of basket trials being initiated. Due to growing adoption of this emerging trial design, Trialtrove has added the term ‘basket’ as a design keyword which makes finding these trials in Trialtrove extremely easy.

 

An overview of oncology basket trials is presented below.

 

Infographic:

 

 

 

References:


1. Heinrich, Michael C., Heikki Joensuu, George D. Demetri, Christopher L. Corless, Jane Apperley, Jonathan A. Fletcher, Denis Soulieres et al. "Phase II, open-label study evaluating the activity of imatinib in treating life-threatening malignancies known to be associated with imatinib-sensitive tyrosine kinases." Clinical Cancer Research 14, no. 9 (2008): 2717-2725.

 

2. Biankin, Andrew V., Steven Piantadosi, and Simon J. Hollingsworth. "Patient-centric trials for therapeutic development in precision oncology." Nature 526.7573 (2015): 361-370.

 

3. Catenacci, Daniel VT. "Next-generation clinical trials: Novel strategies to address the challenge of tumor molecular heterogeneity." Molecular oncology 9.5 (2015): 967-996.

 

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