Clinical Trial 23906

• Overview

  Study Title:

  Open-Label, Cohort-Sequential Dose-Escalation and Dose-Confirmation Phase 1/2 Clinical Trial to Evaluate the Safety and Efficacy of Domatinostat in Combination with Sirolimus in Adolescents and Adults with Relapsed, Refractory Sarcoma and Osteosarcoma

  Summary:

  This is a multicenter, open-label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of domatinostat in combination with sirolimus in adolescents and adults with relapsed or refractory sarcoma and osteosarcoma.

  Objective:

  Primary Objectives Phase 1 and 2: 1. Evaluate the safety and tolerability of domatinostat in combination with sirolimus in adolescents and adults with relapsed or refractory sarcoma (Phase 1) or relapsed or refractory osteosarcoma (Phase 2). Phase 1 only: 2. To determine the MTD and/or RP2D for domatinostat in adolescents and adults with relapsed or refractory sarcoma. Phase 2 only: 3. To assess the antitumor activity of domatinostat and sirolimus in subjects with relapsed or refractory osteosarcoma. Secondary Objectives Phase 1 only: 1. Assess the pharmacokinetics (PK) and pharmacodynamics (PD) of domatinostat and sirolimus when used in combination. 2. Document any observed antitumor activity of domatinostat and sirolimus in subjects with relapsed or refractory sarcoma Exploratory Objectives Phase 2 only: 1. Assess liquid biopsies to determine disease status.

• Treatments

  Therapies:

  HDAC inhibitor; mTOR inhibitor

  Medications:

  Domatinostat (); Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus ()

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