A Phase I Study of AMG 232 in Patients with Advanced Solid Tumors or Multiple Myeloma that Persists Despite Prior Therapy

Full Title

A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 232 in Adult Subjects with Advanced Solid Tumors or Multiple Myeloma

Purpose

The purpose of this study is to evaluate the safety of the investigational drug AMG 232 in patients with multiple myeloma or estrogen receptor-positive metastatic breast cancer, liposarcoma, glioblastoma multiforme, or other solid tumors that contain a damaged form of the MDM2 protein.

Damaged MDM2 can cause cancer cells to grow; AMG 232 blocks MDM2, causing cancer cells to die. However, AMG 232 only has this ability in patients who have a normal form of another protein called p53. Therefore, patients in this study need to have both amplified MDM2 and normal p53. AMG 232 is taken orally (by mouth).

Eligibility

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

  • Patients must have multiple myeloma or estrogen receptor-positive metastatic breast cancer, liposarcoma, glioblastoma multiforme, or another solid tumor with high levels of MDM2 and normal p53.
  • Patients' tumors must continue to grow despite prior treatment.
  • Patients must recover from the serious side effects of previous therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mrinal Gounder at 646-888-4167.

Protocol

15-306

Phase

I

Investigator

Locations