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The purpose of this study is to find the answers to the following research question(s):
1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same way in the body as the approved drug?
ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to prove. All people who participate in this study will receive the research study medication (ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms).
The study drug being tested in this study works the same as the FDA (government) approved drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being delivered (given to the patient).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome) | Active Comparator | Current Standard of care and/or reference product in Europe (Caelyx) and US (Doxorubicin Hydrochloride (Liposome) and Doxil) |
|
| ATI-0918 | Experimental | Investigational drug arm which will be compared to Doxil/Caelyx and Hydrochloride Doxorubicin (Liposome) arms for bioequivalence analysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOXIL/CAELYX | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of AUC in a single dose of ATI0918 vs single dose of Doxil/Caelyx | The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. The outcome measure will be determined by analyzing PK data from drawn from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (Cmax)to determine % variability between ATI0918 and Doxil/Caelyx within each patient. | pre, 30 min + pre, 0, .50, 1, 2, 4, 6, 24, 48, 72, 120, 168, 216 hour post infusion for 2 Cycles (Cycle is defined as 28 days) |
| Comparison of Cmax in a single dose of ATI0918 vs single dose of Doxil/Caelyx | The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. The outcome measure will be determined by analyzing PK data from drawn from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (Cmax)to determine % variability between ATI0918 and Doxil/Caelyx within each patient. | pre, 30 min + pre, 0, .50, 1, 2, 4, 6, 24, 48, 72, 120, 168, 216 hour post infusion for 2 Cycles (Cycle is defined as 28 days) |
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Inclusion Criteria:
Have histologically confirmed ovarian cancer that is potentially sensitive to DOXIL/CAELYX
Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one of which was platinum based.
Be DOXIL/CAELYX treatment naïve
Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of </= 2
Have an estimated life expectancy of ≥ 3 months
Be >/= 18 and </= 70 years of age
Sign a written Institutional Review Board (IRB)-approved informed consent form
Have a negative pregnancy test, if patient is of child-bearing potential
Have acceptable liver function:
Have acceptable renal function:
Have acceptable hematologic status:
Have acceptable coagulation status:
Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yakima Valley Memorial Hospital - North Star Lodge | Yakima | Washington | 98902 | United States | ||
| Centre Hospitalier de L'Universite de Montreal (CHUM) |
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| ATI-0918 | Drug |
|
|
| Montreal |
| Quebec |
| H2L4M1 |
| Canada |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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