This is a Bioequivalence Study between formulations of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (50 mg/m2 dose) for treating Patients with Advanced Ovarian Cancer.

Not yet recruiting

• Conditions: Malignant neoplasm of unspecifiedovary,

• Registration Number: CTRI/2023/03/050946
• Lead Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.

Brief Summary

This is  Multicentric, 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 (50 mg/m2 dose) (Doxorubicin-Test compared with Doxorubicin-Reference) in Patients with Advanced Ovarian Cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-22
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• 1 Participant 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 must be 18 to 75 years of age (both inclusive), at the time of signing the informed consent.3 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.4 Life expectancy of more than or equal to 12 weeks at screening visit.5 An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 at screening visit.6 Participant should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
• Participants who are already receiving doxorubicin hydrochloride liposome injection at a dose of 50 mg/m2 should not require dose reduction(s) in next planned cycle in the study due to toxicity as per the Prescribing Information (PI).7 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 less than 1 per cent per year), with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least six 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 six 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.• Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.6.• 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.8 Participant with adequate hematologic,renal and liver function at screening visit.a Absolute Neutrophil Count (ANC) more than or equal to 1500/mm b Platelet count more than or equal to 75000/mm c Hemoglobin more than or equal to 9.0 g/dL d Estimated Glomerular Filtration Rate (eGFR) of more than or equal to 50 mL/min/1.73 m2 by the CKD-EPI formula e Total Bilirubin less than or equal to 1.2 mg/dL (≤4 × ULN for liver metastasis)f AST and ALT less than or equal to 2.5 × ULN (less than or equal to 4 × ULN for liver metastasis).

Exclusion Criteria

Any potential participant who meets any of the following criteria will be excluded from participating in the study:1 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 well-being)or that could prevent, limit, or confound the protocol-specified assessments.2 Known allergies, hypersensitivity, or intolerance to any of the investigational interventions, or components/ excipients thereof (refer to the PI), or drug or other allergy which is clinically significant in the opinion of the investigator that contraindicates participation in the study.3 Prior doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment.4 Current active systemic opportunistic infection based on clinical assessment.5 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.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.6 Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of investigational intervention.7 Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention.NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained 8 Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.9 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.10 Leptomeningeal disease and known CNS disease (baseline brain imaging is not required for the eligibility assessment), except for treated asymptomatic CNS metastases, provided all of the following criteria are met: a Only supratentorial metastases allowed (ie, no metastases to midbrain, pons, medulla, or spinal cord).b Completed treatment (eg, whole brain radiation treatment [WBRT], stereotactic radiosurgery,or equivalent) at least 14 days prior to the first dose of the study intervention.c No evidence of new or enlarging brain metastases or hemorrhage confirmed by post-treatment repeat brain imaging (using the same modality) performed at least 3 weeks after pre-treatment brain imaging.d Are neurologically stable without the need for steroids for at least 14 days before first dose of the study intervention per local site assessment (anticonvulsants at a stable dose are allowed).11 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 III 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) less than 50percent 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.12 Received an investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to baseline, whichever is longer, prior to baseline.13 Intended use of prohibited medications as mentioned in Section 6.9. Specific medications listed may be allowed.14 Documentation of confirmed novel coronavirus infection (COVID-19) at Visit 2 before randomization.15 Positive test result(s)for urine alcohol or drugs of abuse (including barbiturates, opiates,cocaine, cannabinoids, amphetamines and benzodiazepines) at the time of check-in of Period-I, which is not due to current medical therapy.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetic profile and to assess the bioequivalence of Doxorubicin-Test relative to Doxorubicin-Reference in participants with advanced ovarian cancer.	Pre-dose (0.000), 0.333, 0.667, 1.250, 1.500, 2.000, 2.500, 3.000, 5.000, 8.000, 12.000, 16.000, 24.000, 48.000, 72.000, 120.000, 168.000, 216.000, 264.000, 312.000 and 360.000 hours.

Secondary Outcome Measures

Name	Time	Method
To further characterize the pharmacokinetic profile of Doxorubicin-Test relative to Doxorubicin-Reference in participants with advanced ovarian cancer	Pre-dose (0.000), 0.333, 0.667, 1.250, 1.500, 2.000, 2.500, 3.000, 5.000, 8.000, 12.000, 16.000, 24.000, 48.000, 72.000, 120.000, 168.000, 216.000, 264.000, 312.000 and 360.000 hours.

Trial Locations

Locations (15)

Aadhar Health Institute; 🇮🇳 Hisar, HARYANA, India

AIIMS, Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

Ashirwad Hospital & Research Centre; 🇮🇳 Thane, MAHARASHTRA, India

Erode Cancer Centre; 🇮🇳 Erode, TAMIL NADU, India

Government Medical College & Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

HCG City cancer Center; 🇮🇳 Krishna, ANDHRA PRADESH, India

Indrayani Hospital & Cancer Institute; 🇮🇳 Pune, MAHARASHTRA, India

JNU Institute of Medical Science & Research Centre; 🇮🇳 Jaipur, RAJASTHAN, India

K. R. Hospital, Mysore Medical Collage and Research Institute & Hospital; 🇮🇳 Mysore, KARNATAKA, India

Medstar Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

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Aadhar Health Institute

🇮🇳Hisar, HARYANA, India

Dr Lovenish Goyal

Principal investigator

9896539142

drlovenish@gmail.com