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

NCT02986919 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: STU 092016-074
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Nerve Tumors

Keywords

Malignant peripheral Nerve Sheath Tumors (MPNST); Neurofibromatosis sarcoma

Outcome Measures

Primary Outcomes (3)

• Response rate of CPI-0610

  Establish the response rate of CPI-0610 in MPNST patients

  21 day cycles for 84 days

• Duration of CPI-0610

  Establish the response duration of CPI-0610 in MPNST patients

  21 day cycles for 84 days

• Adverse events associated with CPI-0610

  Describe the adverse events associated with CPI-0610 at the RP2D

  21 day cycles for 84 days

Secondary Outcomes (1)

• Correlate tumor exposure to CPI-0610 with tumor BIM1 expression

  21 day cycles for 84 days

Study Arms (1)

CPI-0610 Treatment

EXPERIMENTAL

CPI-0610 will be administered 200mg orally once a daily for 14 consecutive days followed by a 7-day break.

Drug: CPI-0610

Interventions

CPI-0610 DRUG

* 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.

CPI-0610 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Neoplasms; Neurofibrosarcoma

Interventions

CPI-0610

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Fibrosarcoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 8, 2016
• Study Start: May 5, 2017
• Primary Completion: May 17, 2018
• Study Completion: May 17, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)