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Advanced Ovarian CancerPhase 1NCT07648940

Bioequivalence Study of Liposomal Doxorubicin 20 mg/10 mL (Doxopeg® vs Caelyx®) in Advanced Cancer Patients

A Phase 1 study testing Doxopeg® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) and Caelyx® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) in people with Advanced Ovarian Cancer and Metastatic Breast Cancer, run by Zodiac Produtos Farmaceuticos S.A. at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Doxopeg® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) and Caelyx® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteBrazil
Study dates
13 Feb 2023to 22 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • a Participant with documented advanced ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy AND who are already receiving or scheduled to start the monotherapy with liposomal doxorubicin (pegylated) at a dose of 50 mg/m2.
  • b Participants with documented metastatic breast cancer AND who are already receiving or scheduled to start the monotherapy with liposomal doxorubicin (pegylated) at a dose of 50 mg/m2.
  • Life expectancy of ≥12 weeks at screening visit.
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  • 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
  • A participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • a Is not a woman of childbearing potential (WOCBP) b Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency when used consistently and correctly, during the intervention period and for at least eight months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for at least eight months after the last dose of study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (eg, noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention.
  • A WOCBP must have a negative highly sensitive serum pregnancy test at screening; and urine pregnancy test within 24 hours before the first dose of study intervention.
  • If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Participant with adequate hematologic, renal and liver function at screening visit.
  • a Absolute Neutrophil Count (ANC) with more, or equal than 1500/mm3 b Platelet count more, or equal than 75,000/mm3 c Hemoglobin ≥9.0 g/dL d Estimated Glomerular Filtration Rate (eGFR) of ≥30 mL/min/1.73 m2 by the CKD-EPI formula e Total Bilirubin <1.2 mg/dL f AST and ALT ≤2.5 × ULN (≤ 4 × ULN for liver metastasis)
  • Participant willing and able to adhere to the lifestyle restrictions specified in this protocol

Who cannot join

  • Any potential participant who meets any of the following criteria will be excluded from participating in the study:
  • 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.
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  • 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.
  • History of drug or alcohol abuse according to medical history assessment by investigator within 1 year before screening.
  • History of malignancy except disease under study within the past 3 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence.
  • Known CNS disease, except for treated asymptomatic CNS metastases. Baseline brain imaging is not required for the eligibility assessment. Leptomeningeal disease is always an exclusion.
  • Participant with known history or current symptoms of any of the following clinically significant cardiac conditions:
  • a Unstable angina or myocardial infarction within the past 6 months. b New York Heart Association (NYHA) cardiac disease (Class II or greater) within past 6 months c High-risk uncontrolled arrythmias within past 6 months d Clinically significant pericardial disease within past 6 months e Electrocardiographic evidence of acute ischemic or active conduction system abnormalities within past 6 months f Any other cardiac illness that could lead to a safety risk to the study participant within past 6 months g Participant with a known left ventricular ejection fraction (LVEF) < 50% by echocardiogram or multigated acquisition scan (MUGA) within last 28 days before randomization h Study participants with known coronary artery disease, congestive heart failure not meeting the above criteria, must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
  • Received an investigational intervention or used an invasive investigational medical device within 6 months prior to baseline.
  • Intended use of prohibited medications within 14 days prior to dosing and during the study.
  • Positive Covid-19 RT-PCR test at the time of baseline within 72 hours before hospitalization.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Adium S.A.

    São Paulo

Other trials in Brazil

About this study

Official title: Multicenter, Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two- Sequence, Single Dose, Crossover Bioequivalence Study Between Two Formulations of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) [Doxopeg® Manufactured by FAPASA - Farmaceutica Paraguay S.A. and Registered by Adium S.A., Formerly Zodiac Produtos Farmacêuticos S.A, (Test Formulation) and Caelyx® Manufactured by Janssen Pharmaceutica NV (Reference Formulation)] in Patients With Advanced Ovarian Cancer or Metastatic Breast Cancer

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.

Being tested
Doxopeg® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL), Caelyx® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL)
Keywords
Pegylated liposomal doxorubicin, bioequivalence
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doxopeg® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL)Drug

    Pegylated liposomal doxorubicin hydrochloride concentrate for solution for infusion 2 mg/mL

  • Caelyx® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL)Drug

    Pegylated liposomal doxorubicin hydrochloride concentrate for solution for infusion 2 mg/mL

Study groups in NCT07648940
Study groupRoleWhat they receive
TestExperimentalSingle application of 50mg/m2 by IV infusion
Receives: Drug: Doxopeg® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL)
ComparatorActive comparatorSingle application of 50mg/m2 by IV infusion
Receives: Drug: Caelyx® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax for liposome encapsulated doxorubicin

    Maximum observed plasma concentration

    Measured: Up to 336 hours after drug administration

  2. AUC0-t for liposome encapsulated doxorubicin

    Area under the plasma concentration-time curve from time zero to the last quantifiable concentration

    Measured: Up to 336 hours after drug administration

Secondary outcomes (7)

  1. Cmax for free doxorubicin

    Maximum observed plasma concentration

    Measured: Up to 336 hours after drug administration

  2. AUC0-t for free doxorubicin

    Area under the plasma concentration-time curve from time zero to the last quantifiable concentration

    Measured: Up to 336 hours after drug administration

  3. AUC0-∞

    Area under the plasma concentration-time curve of rivastigmine from time zero to infinite

    Measured: Up to 336 hours after drug administration

  4. Tmax

    Time to reach Maximum observed plasma concentration

    Measured: Up to 336 hours after drug administration

  5. t1/2

    Half life

    Measured: Up to 336 hours after drug administration

  6. Vd

    Distribution Volume

    Measured: Up to 336 hours after drug administration

  7. Cl

    Clearence

    Measured: Up to 336 hours after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start13 Feb 2023
  3. Primary completion22 Jun 2023
  4. Study completion22 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07648940
Sponsor's protocol ID
0063-22
Status last verified
Jun 2026
First submitted
3 Jun 2026
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to confidentiality restrictions and institutional policies regarding participant-level clinical data.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Doxopeg® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) and Caelyx® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) in people with Advanced Ovarian Cancer and Metastatic Breast Cancer, run by Zodiac Produtos Farmaceuticos S.A. at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax for liposome encapsulated doxorubicin (time frame: Up to 336 hours after drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07648940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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