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A Phase 1 Study Evaluating CPI-0610 in Patients With Previously Treated Multiple Myeloma
Bu çalışma, en az bir standart tedaviye rağmen ilerleyen multipl miyelom (multiple myeloma — bir kemik iliği/plazma hücresi kanseri) hastalarında CPI-0610 adlı ilacı inceliyor. Ölçülebilir hastalığı olan, doğrulanmış multipl miyelomu olan 18 yaş üstü hastalar dahil edilmiştir. Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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