Clinical Trials

A Phase I Study of Oral DS-7423 in Patients with Advanced Solid Tumors

Protocol
11-144
Full Title
A Phase 1, Open-Label, Multiple-Escalating-Dose Study of DS-7423, an Orally Administered Dual PI3K/mTOR Inhibitor, in Subjects with Advanced Solid Tumors
Purpose

PI3K and mTOR are two different proteins found to promote the growth of cancer. DS-7423 is an investigational drug that works by inhibiting both PI3K and mTOR. Doctors hope that blocking these proteins can shrink tumors.

In this study, investigators want to find the highest dose of DS-7423 that can be given safely in patients with advanced solid tumors that persist despite standard therapy or for which no standard therapy exists. DS-7423 is a capsule that is taken orally (by mouth).

Investigator
Pictured: Mrinal M. Gounder, MD
Mrinal M. Gounder - Physician Profile
Co-Investigators
Pictured: Richard Carvajal
Richard D. Carvajal - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an advanced solid tumor that persists despite standard therapy or for which no standard therapy exists.
  • Patients must have recovered from the side effects of prior therapies.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Alan L. Ho at 646-888-4235.

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