CTRI/2025/05/087517 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On:
01/07/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
This is a study of Doxorubicin Pegylated Liposomal 2 mg/mL Concentrate for Solution for Infusion in Patients with Advanced Ovarian Cancer or Metastatic Breast Cancer
Scientific Title of Study
A Multicentre, Open Label, Balanced, Randomized, Two-
Treatment, Two-Period, Two-Sequence, Single Dose, Crossover Bioequivalence
Study Between Two Formulations of Doxorubicin Pegylated Liposomal 2
mg/mL Concentrate for Solution for Infusion [Qilu Pharmaceutical (Hainan)
Co., Ltd. (Test Formulation) and Caelyx® Manufactured by Baxter Oncology
GmbH (Reference Formulation)] in Patients with Advanced Ovarian Cancer or
Metastatic Breast Cancer
All India Institute of Medical Sciences, Bhubaneswar
Department of Clinical research, Room No. NA, Sijua, Patrapada, Bhubaneswar, Odisha 751019
Khordha ORISSA
7008651823
drskmishra1984@gmail.com
Dr Prashant Patel
Dhiraj Hospital
Department of Clinical research, Room No. NA, Dhiraj Hospital,SBKS MJ & RC, SVDU at &PO. Piparia. Ta. Waghodia, Vadodara, Gujarat.-391760
Vadodara GUJARAT
9426361710
drprashant22688@gmail.com
Dr K Velavan
Erode Cancer Centre
Department of Clinical research, Room No. NA, 1/393 Velavan Nagar, Perundurai Road, Thindal, Erode- 638012
Erode TAMIL NADU
9842334222
kvels@rediffmail.com
Dr Asma Pathan
Indrayani Hospital and Caner Institute
Department of Clinical research, Room No. NA, Alandi,Chakan Road,Alandi Devachi,Pune Maharastra.-412105
Pune MAHARASHTRA
8007167716
asmapathan124@gmail.com
Dr Prakash SS
K.R Hospital Mysore Medical college and research Institute
Department of Clinical
research, Room No.
NA, Department of surgicle oncology, clinical research room, Ground floor room,No.23, KR Hospital, Mysore, Karnataka- 570001, India
Mysore KARNATAKA
9901000559
prakashyesyes@yahoo.com
Dr Mahesh Kalloli
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre
Department of Clinical research, Room No. NA, Front Entrance, NH Service Road, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum KARNATAKA
9591358733
mahesh.kalloli@gmail.com
Dr Suprana kanti
Life line Diagnostic Center cum Nursing home
Department of Clinical research, Room No. NA, 4A, Wood St, next to Vaardan Market, Kankaria Estates, Elgin, Kolkata, West Bengal 700016
Kolkata WEST BENGAL
9874357580
suparna.k.pal@gmail.com
Dr Sandhyarani Nippani
MNJ Institute of Oncology & Regional Cancer Centre
Department of Clinical research, Room No. NA, Clinical Trial Room no. 11, 3rd floor, Red Hills, Telangna, Hyderabad. 500004
Hyderabad TELANGANA
9849352598
sandhyranippani@gmail.com
Dr Anil M R
Oncovilla Cancer Hospital & Research Centre
Department of Clinical research, Room No. NA, No. 4, 80 feet , Road , 7 the Block Nagarbhavi, 2 Nd Stage , Bangalore -560072, Karnataka India
Bangalore KARNATAKA
9739808502
dranil.onco@gmail.com
Dr Nirali Trivedi
Shankus Hospital
Department of Clinical research, Room No. NA, B/h Divine child school, near shankus water park, Ahmedabad, Mehsana highway, Baliyasan, Gujarat-382732 Ahmadabad GUJARAT
8980008109
nirali_baxi81@yahoo.com
Dr Rajendra Arora
Sujan Surgical &Cancer Hospital
Department of Clinical research, Room No. NA, 52/B Shankar Nagar,Main Road, Amravti, Maharastra.-444605
Amravati MAHARASHTRA
9823097573
rsaroradr@gmail.com
Dr Ankit Patel
Sunshine Global Hospital
Department of Clinical research, Room No. NA, Sunshine Global Hospital (A unit of M/s. Baroda Medicare Private Limited),Beside Smart Bazar, Dumas - Piplod Road,
Surat - 395007, Gujarat (India)
Surat GUJARAT
MNJIORCC Ethics Committee, Dr. Sandhyarani Nippani
Submittted/Under Review
Narsimha Saraswati Medical Foundation, Dr. Asma Pathan
Approved
Amravati Ethics Committee, Dr. Rajendra Arora
Approved
IEC LIFELINE DIAGNOSTIC CENTER CUM NURSING HOME, Dr. Suprana kanti
Approved
IEC-MMC and RI and Associated Hospital, Dr. Prakash S.S
Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE ERODE CANCER CENTRE, Dr. K Velavan
Approved
Institutional Ethics Committee of OCH and RC, Dr. Anil M. R.
Approved
Institutional Ethics Committee of Shankus Hospital, Dr. Nirali Trivedi
Approved
Institutional Ethics Committee Sunshine Global Hospital, Dr. Ankit Patel
Approved
Institutional Ethics Committee, AIIMS, Dr. Sourav Kumar Mishra
Submittted/Under Review
Institutional Ethics Committee, Dr. Mahesh Kalloli
Approved
InstitutionalEthics Committee, SV, Dr Prashant Patel
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C00-D49||Neoplasms,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Doxorubicin pegylated liposomal
concentrate for solution for infusion 2
mg/mL- Test
Dose: 20 mg/10 mL vial,
Route of Administration: IV infusion,
Duration of Dose: 2 cycles.
Each cycle of 28 days in length
Comparator Agent
Doxorubicin pegylated liposomal concentrate for solution for infusion 2
mg/mL(Caelyx)- Reference
Dose: 20 mg/10 mL vial,
Route of Administration: IV infusion,
Duration of Dose: 2 cycles. Each cycle of 28 days in length
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Female
Details
1) Must sign an ICF indicating that the participant understands the purpose of and procedures
required for the study as described in Appendix 10.1.3 and in this protocol and is willing to
participate in the study.
2) Female participant with an age of 18 (or the legal age of consent in the jurisdiction in which
the study is taking place) to 75 years (completed years) of age (both inclusive), at the time of
signing the informed consent.
3) 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 doxorubicin pegylated liposomal at a dose of 50 mg per m2.
b) Participants with documented metastatic breast cancer AND who are already receiving or
scheduled to start the monotherapy with doxorubicin pegylated liposomal at a dose of 50
mg per m2.
4) Estimated life expectancy of greater than or equal to 03 months as assessed by the investigator
5) Body mass index (BMI) within the range of 18.5 to 30 kg per m2 (inclusive).
6) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 at
screening visit. ECOG PS of 2 must be due to disease and not due to comorbid conditions.
7) Participant should have recovered from any toxic effects of previous chemotherapy as judged
by the Investigator. Participants who are already receiving doxorubicin pegylated liposomal
at a dose of 50 mg per m2 should not require dose reduction(s) in next planned cycle in the study
due to toxicity as per the Summary of Product Characteristics (SmPC).
8) Contraceptive use by participants or participants partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly
effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when
used consistently and correctly, as described in Appendix 4 during the intervention period
and for at least 8 months after the last dose of the study intervention. The investigator
should evaluate the effectiveness and the potential for contraceptive method failure (e.g.,
noncompliance, recently initiated) of the contraceptive method in relation to the first dose
of the study intervention. A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their use during the recommended period of contraception. A WOCBP must have a negative highly sensitive pregnancy test (serum) during screening assessments and negative highly sensitive pregnancy test (urine) on day 1 before randomisation, but no more than 3 days 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. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.6. The investigator is responsible for reviewing medical history, menstrual history, and recent
sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy.
9) The participant has adequate hematologic, liver and renal function at screening assessment
a) ANC greater than or equal to 1500 per cu.mm (without granulocyte colony-stimulating factor support within 1 week
prior to the date of the test)
b) Platelet count greater than or equal to 75,000 per cu.mm (without any platelet transfusion per platelet concentrate within 1
week prior to the date of the test)
c) Haemoglobin greater than or equal to 9.0 g per dL (Criteria must be met without erythropoietin stimulating agent dependency and without packed red blood cell (pRBC) or whole blood transfusion within 1 week prior to the date of the test)
d) Estimated glomerular filtration rate (eGFR) of greater than or equal to 50 mL per min per 1.73 sq.m by CKD Epidemiology Collaboration (CKD-EPI) 2021- creatinine equation Note: Exclusionary value of the renal function can be confirmed via repeat testing if deemed
necessary.
e) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 into upper limit of normal (ULN)] (less than or equal to 4 into ULN for participants with liver metastasis) Note: Due to variability and instability, exclusionary value of the transaminases is to be
confirmed via repeat testing to establish proper baseline levels.
f) Total Bilirubin less than 1.2 mg per dL
Note: Due to variability and instability, exclusionary value of bilirubin is to be confirmed via repeat testing to establish proper baseline levels.
10) Willing and able to adhere to the lifestyle restrictions specified in this protocol.
ExclusionCriteria
Details
1) Known allergies, hypersensitivity, or intolerance to any of the study interventions or
components or excipients thereof (refer to the SmPC of Caelyx), or drug or other allergies that,
in the opinion of the investigator, contraindicate participation in the study.
2) Current active systemic opportunistic infection based on clinical assessment.
3) Had major surgical procedure within 2 weeks before the screening, or 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. Surgical implantation of a port catheter is
not exclusionary. NOTE: Participants with any planned surgical procedure under local anaesthesia only may participate if they agree to seek prior approval from the investigator, and such planned
procedure is not expected to prevent, limit, or confound the protocol-specified assessments as
assessed by the investigator.
4) Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the
first dose of investigational intervention.
5) Positive hepatitis C antibody test result at screening or within 3 months prior to starting the
investigational intervention. NOTE: Participants with positive hepatitis C antibody due to
prior resolved disease can be randomized only if a confirmatory negative hepatitis C RNA
test is obtained.
6) Has known human immunodeficiency virus (HIV) seropositive status or positive HIV test at
screening. For participants with unknown HIV status, HIV testing will be performed at
screening unless prohibited by local regulations.
7) 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.
8) Current or chronic history of liver disease. This includes but is not limited to hepatitis
virus infections, drug- or alcohol-related liver disease, non-alcoholic steatohepatitis,
autoimmune hepatitis, hemochromatosis, Wilsons disease, alpha-1 antitrypsin deficiency,
primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease
considered clinically significant by the investigator. Known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones).
9) Participant with clinically significant current or recent (within the past 6 months before
randomisation [unless otherwise specified below]) cardiac conditions as defined below:
a) Acute coronary syndrome, stroke (including transient ischemic attack [TIA]) or other
ischemic event or thromboembolic event (e.g., deep vein thrombosis [DVT], pulmonary
embolism)
b) Clinical risk assessment of cardiac function using the New York Heart Association Functional
Classification of Class II or greater
c) Serious cardiac arrhythmia not controlled by adequate medication, severe conduction
abnormality
d) Clinically significant pericardial disease
e) Electrocardiographic evidence of clinically significant acute ischemic or active conduction
system abnormalities at the screening
f) Any other cardiac illness that could lead to a safety risk to the participant
g) Participants with a known left ventricular ejection fraction (LVEF) less than 50 percentage by echocardiogram or multigated acquisition scan (MUGA) within last 28 days before randomization
Note: 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.
h) Prior doxorubicin anthracycline exposure that would result in a total lifetime exposure of 450
mg per m2 or more after four cycles of treatment.
10) Known active CNS disease, except for participants with either untreated asymptomatic brain metastases or treated brain metastases who are no longer symptomatic, with all of the
following criteria are met: Only supratentorial metastases are allowed (i.e., no metastases to the midbrain, pons, medulla). Completed CNS-specific treatment or treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first two cycle of therapy in the study. No evidence of new or enlarging brain metastases or haemorrhage as ascertained by clinical examination and post-treatment follow-up brain imaging performed at least 4 weeks after CNS-directed treatment. Are neurologically stable without the need for steroids for at least 14 days before the first
dose of the study intervention per local site assessment (anticonvulsants at a stable dose
are allowed).
11) Known history or documented evidence of leptomeningeal disease at screening. NOTE: For the exclusion, LMD is a clinical diagnosis, defined as positive CSF cytology and or
unequivocal radiologic or clinical evidence of leptomeningeal involvement. Participants
with leptomeningeal symptoms in the setting of leptomeningeal enhancement would be
considered to have LMD even in the absence of positive CSF cytology unless a
parenchymal lesion can adequately explain the neurologic deficit. In contrast, an asymptomatic or minimally symptomatic participant with mild or
nonspecific leptomeningeal enhancement would not be considered to have LMD AND
the investigator determines that immediate CNS specific treatment is not required and is
unlikely to be required during the first 2 cycle of therapy in the study. In that participant,
CSF sampling is not required to formally exclude LMD but can be performed at the investigator’s discretion based on the level of clinical suspicion. This is to avoid unnecessary exclusion of patients with imaging-only equivocal findings
12) Spinal cord compression not definitively treated with surgical procedure and or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has
been clinically stable for greater than or equal to 4 weeks prior to Baseline.
13) Past or intended use of any disallowed therapies as noted in Section 6.9, Prior and
Concomitant Therapy within 14 days prior to the first dose of the study intervention.
14) Received any other investigational intervention or used an invasive investigational medical
device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever
is longer, or is currently enrolled in an investigational study.
15) History of clinically significant drug or alcohol abuse according to medical history assessment
by investigator within 1 year before Screening or positive test result(s) for alcohol or drugs
of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and
benzodiazepines) at screening, which is not due to current medical therapy.
16) Previous randomization in the current study regardless of having received the investigational
intervention or not.
17) Donated blood or blood products or had substantial loss of blood (more than 500 mL) within
3 months before the first administration of the study intervention or intention to donate blood
or blood products during the study.
18) Documented medical history of uncontrolled, clinically significant intercurrent medical
condition(s) for which, in the opinion of the investigator, participation would not be in the
best interest of the participant (e.g., compromise the well-being) or that could prevent, limit,
or confound the protocol-specified assessments.
Method of Generating Random Sequence
Random Number Table
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To characterize the pharmacokinetic profile
and to assess the bioequivalence of
doxorubicin pegylated liposomal-Test
relative to doxorubicin pegylated
liposomal-Reference in participants with
advanced ovarian cancer or metastatic
breast cancer
To further characterize the pharmacokinetic profile of doxorubicin pegylated liposomal-
Test relative to doxorubicin pegylated liposomal-Reference in participants with advanced ovarian cancer or metastatic breast cancer
Total Sample Size="68" Sample Size from India="68" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
01/06/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a bioequivalence Study of Doxorubicin Pegylated Liposomal 2 mg/mL Concentrate for Solution for Infusion in Patients with Advanced Ovarian Cancer or Metastatic Breast Cancer to characterize the pharmacokinetic profile and to assess the bioequivalence of test and reference product in participants with advanced ovarian cancer or metastatic breast cancer.