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Ovarian CancerPhase 1NCT05567601

Doxil/Caelyx BE Study

A Phase 1 study testing DOXIL/CAELYX in people with Ovarian Cancer and AIDS-related Kaposi Sarcoma, run by Baxter Healthcare Corporation at 14 sites in India.

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

The aim of this study is to demonstrate the bioequivalence of DOXIL/CAELYX, 40 mg/m2 (IV infusion over 90 minutes) between two manufacturing facilities. According to the Food and Drug Administration (FDA), two products are considered to be bioequivalent when they are equal in the rate and extent to which the active… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
DOXIL/CAELYX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
14 sitesIndia
Study dates
16 Dec 2023to 21 Jun 2024
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be a man or woman aged from 18 to 75 years, inclusive.
  • Patients with advanced or refractory ovarian or breast cancer, expected to require at least 2 cycles of DOXIL/CAELYX therapy at Screening, are eligible for treatment per this study protocol. This includes:
  • Histologically or cytologically confirmed advanced ovarian cancer failing platinum-based chemotherapy
  • Histologically or cytologically confirmed metastatic breast cancer after failing approved life-prolonging therapies
  • Life expectancy greater than 6 months based on the clinical evaluation by the investigator at the time of Screening.
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 2, inclusive.
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  • Recovered from the acute toxicity of any prior treatment (exemptions: alopecia, neuropathy Grade I). All toxicities from prior treatment should return to baseline or Grade I.
  • Prior doxorubicin (or other anthracyclines) at cumulative dose of ≤ 240 mg/m2 or cumulative epirubicin dose ≤ 720 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 0.3 mg mitoxantrone = 0.25 mg idarubicin). Patients without any prior anthracycline exposure can also be included.
  • Adequate liver function as determined by serum total bilirubin levels ≤ 1.2 mg/dL, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 2.5 x ULN.
  • Adequate bone marrow function, as determined by an absolute neutrophil count (ANC) ≥ 1500/mm3 (or ≥ 1.5 x 109/L), a platelet count ≥ 100,000/mm3 (or ≥ 100 x 109/L), and a hemoglobin level ≥ 9 g/dL (or ≥ 90 g/L), in the absence of transfusion requirements or cytokine support for at least 7 days prior to enrolling in the study.
  • Adequate renal function (mL/min), as determined by multiplying estimated glomerular filtration rate (e-GFR) by the body surface area (BSA) and dividing the value by 1.73 m2.
  • Left ventricular ejection fraction (LVEF) within normal limits of the institution, as determined by multiple uptake gated acquisition (MUGA) or echocardiography.
  • Female patients (of childbearing potential) must use medically acceptable methods of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patches, intrauterine devices, the double-barrier method, male partner sterilization) before enrollment, throughout the study and for at least 8 months after the last DOXIL/CAELYX infusion.
  • Male patients must agree to use an adequate contraception method as deemed appropriate by the Investigator and always use condoms when sexually active during the study. Medically acceptable methods of contraception that may be used by the patient and/or his partner include oral contraceptives, contraceptive injections, contraceptive patches, intrauterine devices, the double-barrier method, and surgical sterilization (vasectomy or tubal ligation) for minimally 6 months after the last administration of DOXIL/CAELYX. Sperm donation is not allowed during the study and for minimally 6 months after the last administration of DOXIL/CAELYX.
  • Negative pregnancy test (urinary or serum beta-human chorionic gonadotropin [β-HCG]) at Screening (applicable to women of childbearing potential) within 7 days prior to starting treatment.
  • Patients with no history of addiction to any recreational drug or drug dependence or alcohol addiction.
  • Patients must have signed an informed consent form indicating that they understand the purpose and procedures required, and are willing to participate in the study.

Who cannot join

  • Positive history of known brain metastases or leptomeningeal disease. Patients with brain metastases can only be enrolled if the following conditions are all met:
  • Brain metastases have been treated and stable for > 4 weeks (> 2 weeks after SRS/Cyberknife)
  • No evidence for progression or hemorrhage after treatment
  • Steroid treatment was discontinued at least 2 weeks prior to first administration of DOXIL/CAELYX
  • Enzyme inducing anti-epileptic drugs were discontinued at least 4 weeks before the first administration of DOXIL/CAELYX
  • Has a history of hypersensitivity reaction to doxorubicin HCl or other components of DOXIL/CAELYX.
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  • Has a history of prior or concomitant malignancy that requires other active treatment.
  • Require any antineoplastic treatment while on the study (including therapy with another agent, radiation therapy, and/or surgical resection).
  • Any major surgery, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks prior to the first dose; ≥ 4 weeks for whole brain radiotherapy). Chemotherapy regimens with delayed toxicity within the last 3 weeks (or within the last 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks or 5 half-lives (whichever is shorter).
  • Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of DOXIL/CAELYX.
  • Impaired cardiac function including any of the following conditions within the past 6 months:
  • Unstable angina
  • QTc prolongation (QTc > 470 millisecond) or other significant ECG abnormalities
  • Coronary artery bypass graft surgery
  • Symptomatic peripheral vascular disease
  • Myocardial infarction
  • NYHA class II-IV heart failure
  • Severe uncontrolled ventricular arrhythmias
  • Clinically significant pericardial disease
  • Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  • Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block or heart block) are eligible if their disease has been stable for the past six months
  • Severe uncontrolled arrhythmias
  • Has an infection that is either uncontrolled, clinically important (occurred within 4 weeks prior to first dose of study agent), or requiring current systemic IV treatment.
  • Patients with active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P. carinii or other microorganism if under treatment with myelotoxic drugs
  • Patient has received a diagnosis of COVID-19 (diagnosis ≤ 2 months prior and/or symptoms have not resolved).
  • A patient with uncontrolled concurrent illness including, but not limited to, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that may potentially impair the patient's compliance with study procedures.
  • Concomitant use of strong CYP3A4 inhibitors (such as clarithromycin, diltiazem, erythromycin, itraconazole, ketoconazole, nefazodone, ritonavir, telithromycin and verapamil) and strong CYP3A4 inducers (such as carbamazepine, phenobarbital, phenytoin, rifampin and St John's wort) from at least 4 weeks before the first dose of DOXIL/CAELYX in Cycle 1 and until after completion of all PK sampling on Day 26 of Cycle 2.
  • Has any condition that, in the opinion of the Investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
  • Is a woman who is pregnant, or breast-feeding, or planning to become pregnant within 8 months or is a man who plans to father a child while enrolled in this study or within 6 months after the last dose of study drug.
  • Is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

India14 sites

  • Sujan Surgical Cancer Hospital and Amravati Cancer Foundation

    Amravati, 444605

  • Medstar Speciality

    Bangalore, Karnataka, 560092

  • Oncoville Cancer Hospital & Research Centre

    Bengaluru, Karnataka, 560072

  • Sparsh Hospital & Critical Care Ltd.

    Bhubaneswar, Khndha-Orissa, 751007

  • Erode Cancer Centre

    Erode, Tamil Nadu, 638012

  • Kailash Cancer Hospital and Research Centre

    Goraj, Gurajat, 391760

  • Kolhapur Cancer Center

    Kolhāpur, 416234

  • HCG Manavata Cancer Centre

    Nashik, 422002

  • Indrayani Hospital

    Pune, Maharashtra, 412105

  • Sanjeevani CBCC USA Cancer Hospital

    Raipur, Chhattisgarh, 492001

  • Unique Hospital Multispeciality & Research Institute

    Surat, Gujarat, 395017

  • Swami Har Shankaranand

    Varanasi, Uttar Pradesh, 221005

  • HCG City Cancer Centre

    Vijayawada, Andhra Pradesh, 520002

  • Omega Hospital

    Visakhapatnam, Andhra Pradesh, 530040

Other trials in India

About this study

Official title: A Randomized, Multi-center, Cross-over, Comparative Bioavailability Study of DOXIL/CAELYX Manufactured at a New Site in Patients With Advanced or Refractory Ovarian or Breast Cancer

The aim of this study is to demonstrate the bioequivalence of DOXIL/CAELYX, 40 mg/m2 (IV infusion over 90 minutes) between two manufacturing facilities. According to the Food and Drug Administration (FDA), two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action. Any abnormalities of the safety endpoints (Clinical Laboratory Test, Electrocardiogram, Left Ventricular Ejection Fraction, Physical Examination) will be captured as Adverse Events.

Being tested
DOXIL/CAELYX
Medical subject headings
Ovarian Neoplasms, AIDS-related Kaposi sarcoma, Multiple Myeloma, Breast Neoplasms

What participants receive

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

  • DOXIL/CAELYXDrug

    Also called doxorubicin hydrochloride liposome injection 2 mg/mL

    40 mg/m2 as a 90-minute IV infusion via a central venous catheter or peripheral vein

Study groups in NCT05567601
Study groupRoleWhat they receive
Current Manufacturing SiteActive comparatorOn Day 1 of Cycle 1 of the open-label treatment phase, patients will be randomized to receive drug from either current or new manufacturing site, and then after 28 days cross-over to the drug produced from the other manufacturing site in Cycle 2.
Receives: Drug: DOXIL/CAELYX
New Manufacturing SiteExperimentalOn Day 1 of Cycle 1 of the open-label treatment phase, patients will be randomized to receive drug from either current or new manufacturing site, and then after 28 days cross-over to the drug produced from the other manufacturing site in Cycle 2.
Receives: Drug: DOXIL/CAELYX

What is being measured

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

  1. Cmax based on encapsulated doxorubicin in patients

    Cmax=maximum observed plasma concentration.

    Measured: Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing

  2. AUC0-t based on encapsulated doxorubicin in patients

    AUC0-t=area under the plasma concentration-time curve from time 0 to time t (interchangeable with AUC0-last).

    Measured: Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing

  3. AUC0-∞ based on encapsulated doxorubicin in patients

    AUC0-∞=area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUClast and Clast/λz, in which Clast is the last observed quantifiable concentration. The reference and the test products will be considered bioequivalent if the three 90% CIs for encapsulated doxorubicin fall within (0.80, 1.25).

    Measured: Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing

Secondary outcomes (4)

  1. Cmax based on total doxorubicin in patients

    Cmax=maximum observed plasma concentration. The same analyses as described for encapsulated doxorubicin will be performed for total doxorubicin.If the primary endpoint results in BE, then the secondary endpoints will be tested for BE.

    Measured: Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing

  2. AUC0-t based on total doxorubicin in patients

    AUC0-t=area under the plasma concentration-time curve from time 0 to time t (interchangeable with AUC0-last). The same analyses as described for encapsulated doxorubicin will be performed for total doxorubicin.If the primary endpoint results in BE, then the secondary endpoints will be tested for BE.

    Measured: Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing

  3. AUC0-∞ based on total doxorubicin in patients

    AUC0-∞=area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUClast and Clast/λz, in which Clast is the last observed quantifiable concentration. The same analyses as described for encapsulated doxorubicin will be performed for total doxorubicin.If the primary endpoint results in BE, then the secondary endpoints will be tested for BE.

    Measured: Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing

  4. Tumor response assessment

    By computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis (plus other regions as required for specific tumor types) and other established assessments of tumor burden if CT/MRI imaging is insufficient for the individual patient. Tumor response will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

    Measured: Screening (28 days before Day 1) and between Day 46-56 (10 days before Cycle 3)

Timeline

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

  1. First posted5 Oct 2022
  2. Study start16 Dec 2023
  3. Primary completion21 Jun 2024
  4. Study completion21 Jun 2024

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05567601
Sponsor's protocol ID
BXU572940
Status last verified
Jun 2025
First submitted
29 Sep 2022
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DOXIL/CAELYX in people with Ovarian Cancer and AIDS-related Kaposi Sarcoma, run by Baxter Healthcare Corporation at 14 sites in India.

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 17 inclusion and 30 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in India. 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 based on encapsulated doxorubicin in patients (time frame: Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing). The study lists 3 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 NCT05567601.

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 5 Jun 2025.

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