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

Withdrawn before enrolling · Phase 2

Conditions studied: Peripheral Nerve Tumors

In brief

Establish safety and toxicity profile and preliminary response rate of CPI-0610 in MPNST patients and correlate response with pharmacodynamics markers and BET inhibition.

Key facts

Study ID

NCT02986919

Run by

University of Texas Southwestern Medical Center

People needed

0

Starts

2017-05-05

Expected to finish

2018-05-17

Last updated by the study team

2018-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 greater than or equal to 1,000/mcL
• platelets greater than or equal to 75,000/mcL
• total bilirubin <2X normal institutional limits
• AST(SGOT)/ALT(SPGT) greater than or equal to 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.

You may not qualify if…

• Current infection with HIV, hepatitis B or hepatitis C. Patients will have serologic testing performed during screening for HIV and hepatitis B and C. Any serologic results suggestive of an ongoing viral infection will be further investigated as necessary to clarify the patient's status.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CPI-0610, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade >1.
• Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
• Acute myocardial infarction or angina pectoris <6 months prior to starting study drug
• Uncontrolled cardiac arrhythmia - patients with rate-controlled atrial fibrillation are not excluded.
• A past medical history of other clinically significant cardiovascular disease - e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen.
• Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study - e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection.
• Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI-0610.
• Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610.
• Immunosuppressive treatment that cannot be discontinued prior to study entry and for the duration of the study. Immunosuppressive treatment should be discontinued for at least 1 week prior to start of the administration of CPI-0610. Oral prednisone at a dose of 10mg or less per day is allowed, as are other oral corticosteroids given at glucocorticoid-equivalent doses. Topical, nasal and inhaled corticosteroids are also allowed.
• Pregnant or lactating women.
• Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter.
• Use of strong CYP inhibitors or drugs that carry a definite risk of Torsades de Pointes.
• Patients unwilling or unable to comply with the study protocol.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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