Trials / Unknown
UnknownNCT01715168
A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer
A Phase 1, Single-blind, Randomized, Two-way, Crossover Bioequivalence Study of Intravenously Administered ATI 0918 in Patients With Ovarian Cancer That Has Progressed or Recurred After Platinum-based Chemotherapy
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Azaya Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
- Ovarian Cancer
- Malignant Female Reproductive System Neoplasm
- Cancer
- Ovarian Tumor
- Ovarian Epithelial Cancer Recurrent
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DOXIL/CAELYX | |
| DRUG | ATI-0918 |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2015-10-01
- Completion
- 2015-12-01
- First posted
- 2012-10-26
- Last updated
- 2015-01-15
Locations
2 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01715168. Inclusion in this directory is not an endorsement.