Health Condition 1: null- Ovarian Cancer
Conditions
Interventions
Intervention1: LC-101: DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION, 2mg/mL (50mg/M2 DOSE), administered by Intravenous Infusion through an Infusion Pump. Frequency - Single, at-least 28 days between
Sponsors
Chaya Mazouz
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult female subjects between 18 to 75 years of age at the time of screening visit. 2. Availability of subject for the entire study period and willingness to adhere to protocol requirements. 3. Patients with documented diagnosis of Ovarian Cancer whose disease has progressed or recurred after platinum-based chemotherapy. 4. Subjects eligible for receiving a dose of 50mg/m2 of Doxorubicin liposome (preferably on no other concomitant medication, however, if considered necessary, to be documented and given). 5. Patients with Performance 6. Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance. 7. Signed written informed consent
Exclusion criteria
Exclusion criteria: 1. History or presence of significant: a. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc. b. Clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. c. Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year. d. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, p. carinii or other microorganism e. Clinically significant illness (except ovarian cancer)within four (4) weeks before the start of the study f. Positive result to HIV. g. Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study. 2. Subjects who have: h. Systolic blood pressure less than 90 mmHg or more than 160 mmHg i. Diastolic blood pressure less than 60 mmHg or more than 95 mmHg j. Pulse rate below 60/min. or above 100/min 3. Subject under treatment of myelotoxic drugs 4. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s) 5. Subjects who are legally detained in an official institute
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of subjects participating in the study and to assess the bioequivalence of LC-101 in comparison to LipoDox®, in patients with ovarian cancer.Timepoint: Predose 5 ml each 0.00 0.25 0.50 0.75 1.00 1.083 1.250 1.50 2.00 4.00 6.00 9.00 25.00 49.00 97.00 169.00 241.00 337.00 504.00 672.00 | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary Analytes following 28 Days post treatment Free doxorubicin Liposome encapsulated doxorubicin Secondary Analytes following 28 Days post treatment Doxorubicinol, a metabolite of doxorubicin All samples will be measured in plasma using validated LC/MS/MS methods Timepoint: Not applicable | — |
Countries
India
Contacts
Public ContactKasthuri P K
Quest Life Sciences Pvt. Limited
Outcome results
None listed