Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. To define dose limiting toxicity (DLT). (Phase 1) II. To assess toxicity profile. (Phase 1) III. To determine the recommended phase 2 dose (RP2D). (Phase 1) IV. To perform pharmacokinetic (PK) studies. (Phase 1) V. To examine the effect of CX-5461 (Pidnarulex) on gene expression profile of MYC aberrant lymphomas. (Phase 1) VI. To determine the objective response rate (ORR) (complete response \[CR\] and partial response \[PR\]). (Phase 2) SECONDARY OBJECTIVE: I. To observe and record anti-tumor activity. (Phase 1 and 2) EXPLORATORY OBJECTIVES: I. To determine the mechanisms of response and resistance using circulating tumor deoxyribonucleic acid (ctDNA). (Phase 1 and 2) II. To observe cerebral spinal fluid (CSF) distribution of CX-5461 (Pidnarulex). (Phase 1 and 2) OUTLINE: This is a phase 1 dose-escalation study of CX-5461 followed by a phase 2 study. Patients receive CX-5461 intravenously (IV) over 60 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lumbar puncture with cerebrospinal fluid (CSF) collection on study and positron emission tomography (PET) scan/computed tomography (CT) scan, tumor biopsy, and blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days, every 3-4 months for the first 2 years, and every 6 months for years 3-5.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
