Clinical Trial: Study of CPI-0610 in Patients With Malignant Peripheral Nerve Sheath Tumors

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2 Study of CPI-0610, a Small Molecule Inhibitor of Bromodomain and Extra-Terminal (BET) Proteins, in Patients With Malignant Peripheral Nerve Sheath Tumors

Brief 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.

Detailed Summary:

  • Optional tumor biopsy will be obtained prior to Day 1 of CPI-0610 administration.
  • CPI-0610 will be administered 200mg orally once a daily for 14 consecutive days followed by a 7-day break. The 14 days of CPI-0610 dosing and the 7-day break together constitute 1 cycle of treatment. The dose will not be adjusted for body weight or body surface area.
  • Patients should be instructed to take their daily dose at approximately the same time of day. Each dose should be taken with a glass of water and consumed over as short a time as possible—e.g., within 5 minutes. Patients should be instructed to swallow the tablet whole and to not chew or cut them.
  • Doses may be taken either with or without food.
  • If vomiting occurs during the course of treatment, then no re-dosing of the patient is allowed before the next scheduled dose.
  • If the patient forgets to take his/her daily morning dose, then he/she should take CPI-0610 within 6 hours after the missed dose. If more than 6 hours have passed, then that day's dose should be omitted, and the patient should resume treatment with the next scheduled dose.
  • Repeat optional tumor biopsy will be obtained on day 8 of CPI-0610 treatment.

Toxicities and Dosing Delays/Dose Modifications During a cycle of treatment, CPI-0610 should continue to be administered as planned unless CTCAE grade 3-4 toxicities occur. In the case of CPI-0610-related neutropenia and/or thrombocytopenia, dosing as planned should continue as long as the ANC remains >0.5x109/L and the platelet count remains >25x109/L. Should either the ANC or platelet count fall below these values—become CTCAE grade 4—dosing with CP
Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome:

  • Response rate of CPI-0610 [ Time Frame: 21 day cycles for 84 days ]
    Establish the response rate of CPI-0610 in MPNST patients
  • Duration of CPI-0610 [ Time Frame: 21 day cycles for 84 days ]
    Establish the response duration of CPI-0610 in MPNST patients
  • Adverse events associated with CPI-0610 [ Time Frame: 21 day cycles for 84 days ]
    Describe the adverse events associated with CPI-0610 at the RP2D


Original Primary Outcome: Same as current

Current Secondary Outcome: Correlate tumor exposure to CPI-0610 with tumor BIM1 expression [ Time Frame: 21 day cycles for 84 days ]

Correlate tumor exposure to CPI-0610 with tumor BIM1 expression


Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: November 21, 2016
Date Started: April 2017
Date Completion: March 2020
Last Updated: April 20, 2017
Last Verified: April 2017