A SINGLE-DOSE PHARMACOKINETIC AND BIOAVAILABILITY STUDY OF A GENERIC LIPOSOME-ENCAPSULATED DOXORUBICIN HYDROCHLORIDE FORMULATION IN SUBJECTS WITH EPITHELIAL OVARIAN CARCINOMA WHO HAVE FAILED PLATINUM-BASED CHEMOTHERAPY

Not Applicable

• Registration Number: PER-092-12
• Lead Sponsor: TOLMAR Inc,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

1. FEMALE BETWEEN 18 AND 75 YEARS OF AGE, INCLUSIVE.
2. HISTOLOGICALLY PROVEN EPITHELIAL OVARIAN CARCINOMA.
3. DOCUMENTED PROGRESSIVE OR RECURRENT DISEASE AFTER TREATMENT WITH PLATINUM-BASED CHEMOTHERAPY.
4. ABLE AND CLINICALLY INDICATED TO RECEIVE LIPOSOMAL DOXORUBICIN, AS SPECIFIED IN THE DOXIL PACKAGE INSERT FOR SUBJECTS WITH OVARIAN CANCER, WITHOUT EXCEEDING A LIFETIME CUMULATIVE DOSAGE OF 450 MG/M². PRIOR USE OF OTHER ANTHRACYCLINES OR ANTHRACENEDIONES SHOULD BE INCLUDED IN CALCULATIONS OF TOTAL LIFETIME CUMULATIVE DOSE.
5. BASELINE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS OF ≤ 2 (SEE APPENDIX 15.1).
6. LIFE EXPECTANCY OF AT LEAST 180 DAYS.
7. ACCEPTABLE HEMATOLOGY STATUS:
A. HEMOGLOBIN ≥ 9 g/dl
B. ANC ≥ 1500 CELLS/µl
C. PLATELET COUNT ≥ 75,000 CELLS/µl
8. ACCEPTABLE LIVER FUNCTION:
A. ALANINE AMINOTRANSFERASE (ALT) AND ASPARTATE AMINOTRANSFERASE (AST) ≤ 2X UPPER LIMIT OF NORMAL (ULN)
B. BILIRUBIN < 1.2 mg/dl
C. ALKALINE PHOSPHATASE ≤ 2X ULN

Exclusion Criteria

1. RECEIVED LIPOSOMAL DOXORUBICIN IN THE PAST AND HAD A REQUIRED DOSE REDUCTION TO BELOW 50 MG/M².
2. RECEIVED PREVIOUS CHEMOTHERAPY LESS THAN 3 WEEKS PRIOR TO DOSING OF INVESTIGATIONAL PRODUCT.
3. RECENT (6 MONTH) HISTORY OF MYOCARDIAL INFARCTION OR SEVERE ARRHYTHMIAS PRIOR TO DOSING OF INVESTIGATIONAL PRODUCT (SEE DOXIL PACKAGE INSERT).
4. HISTORY OF MAJOR CARDIAC (NEW YORK HEART ASSOCIATION [NYHA] TYPE III OR IV - SEE APPENDIX 15.2), LIVER, OR KIDNEY DISEASE.
5. RECEIVED ANY PRIOR MEDIASTINAL IRRADIATION (AS CARDIAC TOXICITY MAY OCCUR AT LOWER CUMULATIVE DOSES).
6. RECEIPT OF TRASTUZUMAB FOR 24 WEEKS PRIOR TO DOSING OF INVESTIGATIONAL PRODUCT AND DURING THE STUDY (DOXORUBICIN INJECTION LABELING).
7. RECEIPT OF CYCLOPHOSPHAMIDE, CALCIUM CHANNEL BLOCKERS, AND OTHER POTENTIAL CARDIOTOXIC DRUGS FOR 2 WEEKS PRIOR TO DOSING OF INVESTIGATIONAL PRODUCT (SEE DOXIL PACKAGE INSERT).
8. RECEIPT OF PHENYTOIN FOR 2 WEEKS PRIOR TO DOSING OF INVESTIGATIONAL PRODUCT (SEE DOXIL PACKAGE INSERT).
9. KNOWN HYPERSENSITIVITY, IDIOSYNCRATIC, OR ALLERGIC REACTIONS TO CONVENTIONAL OR LIPOSOMAL FORMULATIONS OF DOXORUBICIN HC1 (EG, DOXIL, CAELYX, DOXOPEG), ANTHRACYCLINE THERAPY OR TO ANY OF THEIR COMPONENTS.

Study & Design

• Study Type: Interventional
• Study Design: Not specified