A Phase 1 Study Evaluating CPI-0610 in Patients With Previously Treated Multiple Myeloma

Constellation Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: CPI-0610

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02157636

0610-03

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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