Bioequivalence Study of Liposomal Doxorubicin 20 mg/10 mL (Doxopeg® vs Caelyx®) in Advanced Cance… (NCT07648940) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Liposomal Doxorubicin 20 mg/10 mL (Doxopeg® vs Caelyx®) in Advanced Cancer Patients
Brazil74 participantsStarted 2023-02-13
Plain-language summary
To characterize the pharmacokinetic profile of pegylated liposomal doxorubicin formulations, a multicenter, randomized, two-period crossover study was conducted in 74 patients with advanced ovarian cancer or metastatic breast cancer. Blood samples were collected up to 336 hours post-dose, and plasma concentrations of encapsulated and free doxorubicin were quantified using validated LC-MS/MS methods. Pharmacokinetic parameters (Cmax, AUC0-t, AUC0-inf, tmax, t1/2, Vd, and Cl) were calculated using noncompartmental analysis.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study.
. Female participant must be 18 to 75 years of age (both inclusive), at the time of signing the informed consent.
. Participant meeting one of the following criteria:
. Life expectancy of ≥12 weeks at screening visit.
. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 at screening visit.
. Participant should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator. Participants who are already receiving liposomal doxorubicin (pegylated) at a dose of 50 mg/m2.should not require dose reduction(s) in next planned cycle in the study due to toxicity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax for liposome encapsulated doxorubicin
Timeframe: Up to 336 hours after drug administration
2
AUC0-t for liposome encapsulated doxorubicin
Timeframe: Up to 336 hours after drug administration
. A participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
. Participant with adequate hematologic, renal and liver function at screening visit.
Exclusion criteria
. Documented medical history of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments.
. Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/ excipients thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
. Prior doxorubicin exposure that would result in a total lifetime exposure of 450 mg/m2 or more after four cycles of treatment.
. Current active systemic opportunistic infection based on clinical assessment.
. Had major surgical procedure and will not have fully recovered from surgical procedure, or has surgical procedure planned during the time the participant is expected to participate in the study.
. Presence of hepatitis B surface antigen (HBsAg) or IgM anti-HBC at screening or within 3 months prior to first dose of investigational intervention.
. Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention.
. Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.