A study to evaluate the safety of Doxorubicin from Panacea Biotech Ltd (test drug) in comparison to the Doxorubicin of Sun Pharmaceuticals Ind. Ltd. (reference drug) in ovarion cancer patients
- Conditions
- Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
- Registration Number
- CTRI/2017/03/008179
- Lead Sponsor
- Panacea Biotech Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
1. Female patients between 18-65 years of age. (Both Inclusive)
2. Patients must be able to understand the investigational nature of this study and to give
written informed consent prior to the participation in the trial.
3. Patients with histopathologically /cytologically confirmed Ovarian Cancer requiring
Doxorubicin
4. Patient with Ovarian Cancer whose disease has progressed or recurred after Platinum-based
Chemotherapyand who are already receiving or scheduled to start the therapy with
Doxorubicin.
5. Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
6. Cardiac function (left ventricular ejection fraction [LVEF] >=50%.
7. Patient should have recovered from any toxic effects of previous chemotherapy as judged by
the Investigator.
8. Patients with life expectancy of at least 3 months.
9. Able to comply with study requirement in opinion of Investigator.
10. Adequate hematologic status, Renal and Liver function.
A]Hematologic status:
ANC >= 1500/mm3
Platelet count >= 100,000/mm3
Haemoglobin >= 9.0 g/dl
B]Renal function Serum Creatinine < 1.5 times ULN.
C]Hepatic Function:
AST and ALT < 2.5 times ULN
Alkaline phosphatase < 2 times ULN
phosphatase < 2 times ULN
Bilirubin < ULN
11. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug
administration) or postmenopausal for at least 12 consecutive months, must 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 12 weeks prior to study drug administration,
during study and up to 30 days after the last dose of compassionate medications. Cessation
of birth control after this point should be discussed with a responsible physician.
The investigator should ensure that the patient is using an effective method of avoiding
pregnancy as per protocol.
12. 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.
1. Pregnant or breast-feeding female.
2. Prior Doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment
3. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.carinii or other microorganism if under treatment with myelotoxic drugs.
4. Significantly impaired hepatic function and kidney function.
5. Impaired cardiac function including any of the following conditions within past 6 months:
i. Unstable angina
ii. QTc prolongation or other significant ECG abnormalities.
iii. Coronary artery bypass graft surgery.
iv. Symptomatic peripheral vascular disease.
v. Myocardial infarction
vi. NYHA class II-IV heart failure
vii. Severe uncontrolled ventricular arrhythmias
viii. Clinically significant pericardial disease
ix. Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
x. 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.
xi. Severe uncontrolled arrhythmias.
6. History of hypersensitivity reactions attributed to a conventional formulation of Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride liposome injection.
7. Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug addiction.
8. Known brain metastasis.
9. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI criteria.
10. Other serious illness or medical condition that would prohibit the understanding and giving of informed consent.
11. A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
12. Known cases of HIV and/or syphilis.
13. The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior to the first dose of investigational Product (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study).
14. Any other condition/Abnormal baseline that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
15. Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
16. 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).
17. History of cerebrovascular accident (CVA), MI within 06 months or venous thrombosis within 12 weeks. (Patients with previous history of venous thrombosis on a stable dose of anticoagulation are allowed.)
18. Patients who are smokers or tobacco users in any form.
19. Past or current history of neoplasm other than the Ovarian Cancer and with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix.
20. Patients must not have taken any potent CYP3A4 inhibitors/inducers <= 30 days prior to enrolment including but not limited to: Ketoconazole, Itraconazole, Troleandomycin, Clarithromycin, Erythrom
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetivc Parameters namely, Cmax (Maximum Measured Plasma Concentration) <br/ ><br>AUC0-t(Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration) and <br/ ><br>AUC0- (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity)Timepoint: Day 1 and Day 29.
- Secondary Outcome Measures
Name Time Method To monitor the safety of the patients, who are exposed to the Investigational Medicinal ProductTimepoint: Day 1, Day 28 and Day 56.