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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02986919
Recruitment Status : Withdrawn (Lack of enrollment.)
First Posted : December 8, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Peripheral Nerve Tumors Drug: CPI-0610 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 5, 2017
Actual Primary Completion Date : May 17, 2018
Actual Study Completion Date : May 17, 2018


Arm Intervention/treatment
Experimental: CPI-0610 Treatment
CPI-0610 will be administered 200mg orally once a daily for 14 consecutive days followed by a 7-day break.
Drug: CPI-0610
  • 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.




Primary Outcome Measures :
  1. Response rate of CPI-0610 [ Time Frame: 21 day cycles for 84 days ]
    Establish the response rate of CPI-0610 in MPNST patients

  2. Duration of CPI-0610 [ Time Frame: 21 day cycles for 84 days ]
    Establish the response duration of CPI-0610 in MPNST patients

  3. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years
  2. Must have histologically confirmed diagnosis of MPNST
  3. Must have measurable disease by CT scan or MRI
  4. Eastern Cooperative Oncology Group - ECOG performance status <2
  5. 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
  6. 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.
  7. 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.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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

  4. Uncontrolled cardiac arrhythmia - patients with rate-controlled atrial fibrillation are not excluded.
  5. 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.
  6. 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.
  7. Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI-0610.
  8. Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-0610.
  9. 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.
  10. Pregnant or lactating women.
  11. 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.
  12. Use of strong CYP inhibitors or drugs that carry a definite risk of Torsades de Pointes.
  13. Patients unwilling or unable to comply with the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986919


Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02986919     History of Changes
Other Study ID Numbers: STU 092016-074
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Texas Southwestern Medical Center:
Malignant peripheral Nerve Sheath Tumors (MPNST); Neurofibromatosis sarcoma
Additional relevant MeSH terms:
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Nerve Sheath Neoplasms
Neurofibrosarcoma
Peripheral Nervous System Neoplasms
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Fibrosarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Neurofibroma
Neoplasms by Site