A Phase 1 Study Evaluating CPI-0610 in Patients With Previously Treated Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Phase 1, Oncology, BET Inhibitor
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CPI-0610
Type: Drug
Overall Status
Recruiting
Summary
Open-label, sequential dose escalation and expansion study of CPI-0610 in patients with previously treated multiple myeloma. CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Adults (aged ≥ 18 years)

- Histologically or cytologically confirmed diagnosis of multiple myeloma that has progressed despite at least one line of standard therapy

- Must have measurable disease, defined by one or more of following: (i) a serum M protein > 0.5 g/dl measured by serum protein electrophoresis; (ii) urinary M protein excretion > 200 mg/24 hours; (iii) serum free light chain (FLC) measurement > 10 mg/dl, provided that the serum FLC ratio is abnormal

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2

- Adequate hematological, renal, hepatic, and coagulation laboratory assessments

- Written informed consent to participate in this study before the performance of any study-related procedure

Exclusion Criteria:

- Current infection with HIV, Hepatitis B or Hepatitis C

- 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

- Serum cardiac troponin (cTn) level ≥ 99% percentile of the upper reference limit

- QTcF > 470 msec on the screening ECG

- Left ventricular ejection fraction (LVEF) < 50%

- Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)

- 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. In addition, the first dose of CPI-0610 should not occur before a period equal to or greater than 5 half-lives of the small molecule investigational agent has elapsed

- Treatment with a therapeutic antibody less than 4 weeks before the first dose of CPI-0610. A minimum 2-week period between the last treatment with a therapeutic antibody and the first dose of CPI-0610 may be permitted in patients with rapidly progressive myeloma, following discussion with the medical monitor

- Treatment with medications that are known to be strong inhibitors or inducers of CYP450 enzymes

- Treatment with medications that are known to carry a risk of Torsades de Pointes

- Immunosuppressive treatment that cannot be discontinued both prior to study entry and for the duration of the study. Oral prednisone at a dose of 10 mg 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

- Patients unwilling or unable to comply with the study protocol
Locations
Mayo Clinic
Scottsdale, Arizona, United States
Status: Recruiting
Contact: Clinical Trials Office All Mayo Clinic Locations - 507-538-7623
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Noopur Raje, MD - 617-724-4000
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Rita Bhagat, BS, RN, BSN, CCRP - 215-614-0548 - rita.bhagat@uphs.upenn.edu
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Status: Recruiting
Contact: Salah Nabhan - 615-329-7215 - Salah.Nabhan@scresearch.net
Start Date
July 2014
Completion Date
December 2015
Sponsors
Constellation Pharmaceuticals
Source
Constellation Pharmaceuticals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page