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To Evaluate Maximally Tolerated Dose (MTD), Safety and Efficacy of CPI-613 (Devimistat) Plus Hydroxychloroquine in Patients With Relapsed or Refractory Clear Cell Sarcoma of Soft Tissue


The goal of this trial in Phase I is to determine the maximally tolerated dose (MTD) of
hydroxychloroquine in combination with devimistat in patients with relapsed or refractory
Clear Cell Sarcomas of the Soft Tissue and to describe the full toxicity profile. In Phase
II, the goal is to evaluate the response rate [Complete Rate (CR) + Partial Rate (PR)] of the
combination of devimistat and hydroxychloroquine in patients with relapse or refractory Clear
Cell Sarcoma of the Soft Tissue and to evaluate the PK and PK/PD profiles for efficacy and
safety of the combination of devimistat and hydroxychloroquine.
Davis, Elizabeth