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About
This randomized phase I trial studies the side effects and best dose of nanosomal docetaxel lipid suspension in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as nanosomal docetaxel lipid suspension, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Full description
PRIMARY OBJECTIVES:
I. To assess the pharmacokinetics profile of nanosomal docetaxel lipid suspension (NDLS) in patients with advanced solid tumors.
SECONDARY OBJECTIVES:
I. To assess the safety and toxicity of NDLS in patients with advanced solid tumors.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive lowest dose nanosomal docetaxel lipid suspension intravenously (IV) over 1 hour.
ARM II: Patients receive low dose nanosomal docetaxel lipid suspension IV over 1 hour.
ARM III: Patients receive high dose nanosomal docetaxel lipid suspension IV over 1 hour.
ARM IV: Patients receive highest dose nanosomal docetaxel lipid suspension IV over 1 hour. In all arms, treatment may repeat every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Enrollment
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Inclusion criteria
Exclusion criteria
Hypersensitivity to docetaxel injection or any of its excipients
Intolerance to any antineoplastic agents belonging to the taxane family
Prior anticancer therapy within 28 days prior to the first day of study treatment
Participation in another experimental drug study within 30 days prior signing the informed consent form (ICF)
Any of the following cardiac conditions:
Use of any recreational drugs or history of drug addiction
Known history of brain metastasis
Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by National Cancer Institute (NCI) criteria
Positive hepatitis screening (hepatitis screen includes hepatitis B surface antigen [HBsAg], hepatitis C virus [HCV] and hepatitis A virus [HAV] [immunoglobulin M (IgM)] antibody)
Known case of active infection including human immunodeficiency virus (HIV) infections
Any other condition that, in the investigator's judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine
Known, existing uncontrolled coagulopathy
Primary purpose
Allocation
Interventional model
Masking
13 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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