Bioequivalence study ofDoxorubicin Hydrochloride (Pegylated liposomal concentrate for solution for infusion 20 mg/10mL (2 mg/ml) in advanced ovarian cancer.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C569- Malignant neoplasm of unspecifiedovary
- Registration Number
- CTRI/2015/10/006241
- Lead Sponsor
- Dr Reddys Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
1. Females of Indian Nationality, between 18-65 years of age (both inclusive).
2. Ability to understand and provide written informed consent prior to participation in the study.
3. Patients with advanced ovarian cancer requiring Doxorubicin and who have failed a first-line platinum-based chemotherapy regimen. Or As monotherapy for patients with metastatic breast cancer.
4. Cardiac function (left ventricular ejection fraction [LVEF] >=50%.
5. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
6. Patients with life expectancy of at least 3 months.
7. Able to comply with study requirement in opinion of Principal Investigator.
8. Adequate Hematopoietic, Renal and Liver function defined as the following:
Bone marrow function:
ANC >= 1500/mm3
Platelet count >= 100,000/mm3
Haemoglobin >= 9.0 g/dl
Renal function:
S. Creatinine < 1.5 x upper limit of normal ULN)
Hepatic function:
AST and ALT <= 2.5 Ã? ULN (<= 4 Ã? ULN for liver metastasis)
Alkaline phosphatase < 2 x ULN (<= 5 Ã? ULN for bone metastasis).
Total Bilirubin <= 1.5 Ã? ULN
9. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of minor surgery; at least 4 weeks must have elapsed from the time of major surgery.
10. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12
consecutive months, must have negative pregnancy test at screening as well as prior to check-in and must agree to use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. It is investigator responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol.
1. Patients who are pregnant or breast feeding.
2. Patients with an ECOG (Eastern Cooperative Oncology group)Performance Status Score > 3.
3. If total cumulative dose of Doxorubicin HCl approaches 450 mg/m2
4. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.carinii or other microorganism if under treatment with myelotoxic drugs.
5. Any other clinically significant liver or kidney disorders other than mentioned in the selection criteria.
6. Impaired cardiac function including any of the following conditions within past 6 months:
a. Unstable angina
b. QTc prolongation or other significant ECG abnormalities.
c. Coronary artery bypass graft surgery.
d. Symptomatic peripheral vascular disease.
e. Myocardial infarction
f. NYHA class II-IV heart failure
g. Severe uncontrolled ventricular arrhythmias
h. Clinically significant pericardial disease
i. Electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
j. 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.
k. Severe uncontrolled arrhythmias.
7. History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride or the components of Caelyx®.
8. Use of any recreational drugs or history of drug addiction.
9. Known brain metastasis.
10. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI criteria.
11. Other serious illness or medical condition that would prohibit the understanding and giving of informed consent.
12. A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
13. A positive test result for HIV antibody and/or syphilis.
14. The receipt of an investigational product, or participation in a drug research study within a period of 90 days prior to the first dose of
investigational Product.
15. Any other condition that, in the investigator judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
16. Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
17. Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the patient unlikely to fully complete the
study, or any condition that presents undue risk from the study medication or procedures.
18. History of donation of blood/loss of blood (without replenishment) (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
19. Uncontrolled hypertension (systolic blood pressure [BP] >180 or diastolic BP >100mm Hg) or uncontrolled cardiac arrhythmias (Patients with hypertension controlled by antihypertensive therapies are eligible).
20. History of cerebrovascular accident (CVA), MI within 6 months or venous thrombosis within 12 weeks. (Patients with previous history of venous thrombosis on a stable dose of anticoagulation are allowed).
21. Mental condition that would prevent patient comprehension of the nat
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the bioequivalence of the Test Produc (Doxorubicin Hydrochloride (Pegylated liposomal)concentrate for solution for <br/ ><br>infusion 20 mg/10mL (2mg/mL)) relative to that of Reference Product (Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) <br/ ><br>concentrate for solution for infusion (20 mg/10mL)]) in advanced ovarian cancer patients who have failed a first-line platinum based chemotherapy regimen or patients with metastatic breast cancer.Timepoint: To assess the bioequivalence of the Test Produc (Doxorubicin Hydrochloride (Pegylated liposomal)concentrate for solution for <br/ ><br>infusion 20 mg/10mL (2mg/mL)) relative to that of Reference Product (Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) <br/ ><br>concentrate for solution for infusion (20 mg/10mL)]) in advanced ovarian cancer patients who have failed a first-line platinum based chemotherapy regimen or patients with metastatic breast cancer.
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of the patients.Timepoint: NA