Status and phase
Conditions
Treatments
About
AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without food and without any rest periods, as long as there is no evidence of disease progression or unacceptably severe adverse events (AEs) related to the study drug.
Full description
A phase 1 open-label, dose finding study of AC220 in patients with solid tumors.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Males and females age ≥18 years
Understand and voluntarily sign the informed consent form for this study
Available for periodic follow-up at the investigative site
Able to swallow the liquid study drug
ECOG performance status of 0 - 2
Histological diagnosis of a primary solid tumor malignancy that meets the following criteria:
Measurable disease by computer tomography (CT) or magnetic resonance imaging (MRI) scans per RECIST.
Prior anticancer therapy, radiotherapy, hormonal, and immunotherapy are allowed. Patients must have recovered from toxicity of prior therapy (ie, toxicity has resolved to Grade 1, or to pre-treatment baseline, or is deemed irreversible). At least 4 weeks must have elapsed since the last systemic therapy (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin), immunotherapy, or radiotherapy and the beginning of study drug administration. For participants with GIST on approved tyrosine kinase inhibitors (TKI), at least 2 weeks must have elapsed since the last dose of TKI.
Adequate bone marrow function, defined as:
Adequate hepatic function, defined as:
Adequate renal function, defined as:
Prothrombin time or partial thromboplastin time (PT- PTT) ≤ 1.5 x the ULN
Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits, and every effort should be made to keep potassium concentrations above 4.0 mEq/dL, magnesium concentrations above 1.8 mg/dL, and serum calcium at normal concentration with the administration of oral/IV potassium and/or magnesium and/or calcium replacement during the study. If this is not possible, potassium and magnesium (and calcium) concentrations should at least be kept within institutional normal limits.
Fully recovered (≤ Grade 1 or returned to baseline or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug administration.
Baseline left ventricular ejection fraction (LVEF) ≥ 45% (or ≥ institutional lower limit of normal if institutional lower limit of normal is below 45%) as assessed by 2-dimensional ECHO or MUGA as per institutional practice. If repeat LVEF assessment is required, the same modality should be used throughout the duration of study, whenever possible.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study in such a manner that the risk of pregnancy is minimized. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not post menopausal (defined as amenorrhea > 12 consecutive months; or who is on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Additionally, premenopausal women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, are practicing abstinence, or whose partner is sterile (eg, vasectomy), should be considered to be of childbearing potential.
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 72 hours prior to the start of study drug.
Exclusion criteria
WOCBP who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy for the entire study period and for at least 3 months after the study.
Women who are pregnant or breastfeeding
WOCBP with a positive pregnancy test on enrollment prior to study drug administration
Men who are unwilling or unable to use an acceptable method of birth control if their sexual partners are WOCBP for the entire study period and for at least 3 months after completion of the study
Patients with known untreated, symptomatic or uncontrolled brain or central nervous system (CNS) metastases. Patients with treated brain or CNS metastases that are radiographically stable for 3 months or longer are eligible.
A serious uncontrolled medical disorder or active infection which would impair the ability of the patient to receive study drug
Uncontrolled or significant cardiovascular disease, including:
Known infection with human immunodeficiency virus (HIV)
Known active hepatitis A, B, or C or other active liver disease
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
Investigational agents during or within 4 weeks prior to the start of study drug
Use of drugs that are generally accepted to have a risk of causing prolonged QTc and/or TdP and/or are CYP3A4 inhibitors. Patients who have discontinued any of these medications must have a washout period of at least 5 days or at least 5 half-lives of the drug (whichever is greater) prior to the first dose of study drug and should not be allowed to take these medications during the study drug dosing.
Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator or Sponsor, could jeopardize patient safety or interfere with the objectives of the study.
Primary purpose
Allocation
Interventional model
Masking
45 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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