A phase 2 study of CPI-0610, a small molecule inhibitor of BET proteins, in patients with malignant peripheral nerve sheath tumors

Study ID
STU 092016-074

Study Sites

  • UT Southwestern Ambulatory Services

Contact
Rafael Leon
214/648-1929
Rafael.Leon@UTSouthwestern.edu

Principal Investigator
Jade Homsi, M.D.

Summary

establish safety and toxicity profile and preliminary response rate of CPi-0610 in MPnST patients and correlate response with pharmacodynamics markers and BeT inhibition.

Participant Eligibility

Age >18 years
-Must have histologically confirmed diagnosis of MPNST
-Must have measurable disease by CT scan or MRI.
-Eastern Cooperative Oncology Group-ECOG performance status <2
-Adequate organ and marrow function as defined below:
- absolute neutrophil count >= 1,000/mcL
- platelets >= 75,000/mcL
- total bilirubin <2X normal institutional limits
- AST(SGOT)/ALT(SPGT) <= 2.5 X institutional upper limit of normal
- creatinine <2X institutional upper limit of normal
-Patients must have fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy-residual grade 1 toxicity, e.g., grade 1 peripheral neuropathy and residual alopecia are allowed.
-Female patients who are pre-menopausal or have experienced menopause for less than 2 years must have a negative serum pregnancy test <72 hours before starting study treatment. Male and female patients with reproductive potential must agree to use appropriate contraceptive methods while on study and for 3 months after the last dose of CPI-0610. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.