Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Texas Tech University Health Sciences Center, El Paso
The dose and schedule of AUY922 is the MTD dose identified in the phase I, given as 1 hour infusion weekly. The Phase II component will have a 2 stage design single arm design. (Section 9.0). Overall response rate (ORR) is the primary endpoint. Estimated N=40 (12 in first stage) .A total of 39 response-evaluable participants is required. In the first stage, 12 response-evaluable participants will be accrued; if there are 3 or fewer CR+PRs, the study will stop for futility. There is a 55% probability of stopping early if, in fact, the ORR is 28%. If there are 4 or more CR+PRs, the study will proceed to the second stage and an additional 27 response-evaluable participants will be accrued. We will accrue 1 additional patient (then the needed 39 to account for attrition)
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
