A Phase I Study of INK128 (MLN0128) in Patients with Advanced Kidney, Bladder, or Endometrial Cancer

Full Title
A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent INK128 in Subjects with Advanced Malignancies Followed by an Expansion in Subjects with Measurable Disease

MLN0128 (formerly known as INK128) is an investigational anticancer drug that works by blocking a molecular signaling pathway that is overactive in some cancers. The purpose of this study is to find the highest dose of MLN0128 that can be given safely in patients. The highest levels are currently being further explored in patients with advanced cancers of the kidney, bladder, or endometrium (uterine lining) whose tumors have spread and continue to grow despite prior treatment. MLN0128 is a capsule that is taken orally (by mouth).


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

  • Patients must have advanced cancer of the kidney, bladder, or endometrium (uterine lining) that has spread and continues to grow despite prior treatment.
  • At least 2 weeks must have passed since completion of prior therapy and entry into the study.
  • 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.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Voss at 646-422-4631.