A Randomized, Open Label, Two Treatments, Two Periods, Two Sequences, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection 2 mg/ml (50mg/m2 dose) in patients with Ovarian Cancer

Completed

• Conditions: Ovarian Cancer

• Registration Number: CTRI/2014/06/004689
• Lead Sponsor: Chaya Mazouz

Brief Summary

This will be a randomized, multi center, open label,two treatments, two periods, two sequences, single dose, crossover,bioequivalence study of Doxorubicin Hydrochloride Liposome injection, 2 mg/mL(50 mg/m2 dose). Subjects will betreated first with a single dose of the RLD (approved liposomal DoxorubicinHydrochloride) or suggested generic formulation. Following 30+2 daysafter first treatment the same subject will be treated with the suggestedgeneric formulation or RLD, respectively.

 The study will comprise:

 1.     Screeningperiod of up to 30 days

 2.     Firsttreatment with RLD or generic formulation

 3.     PKBlood sampling through Day 28

 4.     Secondtreatment with RLD or generic formulation on Day 30+2 days

 5.      PKBlood sampling through Day 56 and termination visit (28 days post secondtreatment)

A sufficient number of patients with ovariancancer shall be recruited in order to complete the study with at least 24 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-16
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 24

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 ≤ 2 on the ECOG performance scale.
• 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

• 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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
Primary Analytes following 28 Days post treatment	Free doxorubicin

Trial Locations

Locations (4)

Axon Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

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

G Viswanathan Speciality Hospitals; 🇮🇳 Tiruchirappalli, TAMIL NADU, India

MNJ Institute of Oncology & Regional Cancer Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Axon Hospitals

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Balashankar

Principal investigator

9440167173

sankarrmc2004@yahoo.co.in