Multiple Myeloma Clinical Trial
Official title:
A Randomized, Multi-center, Cross-over, Comparative Bioavailability Study of DOXIL/CAELYX Manufactured at a New Site in Patients With Advanced or Refractory Ovarian or Breast Cancer
The aim of this study is to demonstrate the bioequivalence of DOXIL/CAELYX, 40 mg/m2 (IV infusion over 90 minutes) between two manufacturing facilities. According to the Food and Drug Administration (FDA), two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action. Any abnormalities of the safety endpoints (Clinical Laboratory Test, Electrocardiogram, Left Ventricular Ejection Fraction, Physical Examination) will be captured as Adverse Events.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Phase 3 | |
| Active, not recruiting |
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Phase 1 | |
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N/A | |
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Phase 3 | |
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Phase 2 | |
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Phase 1 | |
| Recruiting |
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Phase 2 | |
| Terminated |
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Phase 1 | |
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Phase 1/Phase 2 | |
| Completed |
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Phase 1/Phase 2 | |
| Active, not recruiting |
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Phase 1 | |
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|
Phase 1/Phase 2 | |
| Active, not recruiting |
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Phase 2 | |
| Withdrawn |
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|
Phase 2 | |
| Recruiting |
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Phase 1 | |
| Completed |
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CART-BCMA Cells for Multiple Myeloma
|
Phase 1 |