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Also known as Doxorubicin Hydrochloride Liposome Injection
Doxorubicin Liposome · 1 trial · 1 indication
The study end point will use PK parameter ( Cmax ) for free doxorubicin and liposome encapsulated doxorubicin
The study endpoint will use the PK parameter ( AUC 0-t) for free doxorubicin and liposome encapsulated doxorubicin ( AUC 0-t)
The study endpoint will use the PK parameter ( AUC 0-Inf) for free doxorubicin and liposome encapsulated doxorubicin
| Arm | Type | Description |
|---|---|---|
| Test Product - T | EXPERIMENTAL | doxorubicin hydrochloride liposome ( Dr. Reddy's Lab ) Use the test drug (doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Dr.Reddy's Laboratories Ltd., India) ; then use the reference drug ( doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Sun Pharma ) after at least 4-weeks. |
| Reference Product - R | ACTIVE_COMPARATOR | doxorubicin hydrochloride liposome ( Sun Pharma ) Use the reference drug (doxorubicin Hydrochloride Liposome Injection 20mg/10mL i.e. 2mg/mL; from Sun Pharma ) ; then use the test drug ( doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Dr.Reddy's Laboratories Ltd., India) after at least 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Doxorubicin Hydrochloride Liposome Injection | DRUG | 50mg/m2, IV on Day 1 of each cycle, On Day 1 of Cycle 2 , patients will crossover to the alternate reference or test formulation , After completion of Cycle 2 ( Day 28) , patients will be continued on the treatment of Doxorubicin Hydrochloride Liposome injection upto 4 more cycles if tolerance permits under guidance of their attending physicians. |
Inclusion Criteria: * Female of Indian Nationality , between 18-60n years of age * Able to understand investigational nature of this study and give written informed consent prior to the participation in the trial. * Patients with ovarian cancer requiring Doxorubicin and whose disease has progressed...
Doxorubicin Liposome is being studied for recurrent ovarian epithelial cancer. It is a liposomal formulation of doxorubicin, an oncology small molecule. Development is at Phase 1, and the drug is investigational rather than approved for this indication.
Doxorubicin Liposome targets TOP2A, topoisomerase II alpha. It acts as an inhibitor of this enzyme. TOP2A is involved in DNA replication and cell division, and inhibiting it interferes with those processes in cancer cells.
Doxorubicin Liposome is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical program for this liposomal doxorubicin formulation.
Doxorubicin Liposome is in Phase 1 development. It is investigational and has not been approved for recurrent ovarian epithelial cancer. The program includes one completed Phase 1 trial, with no active trials currently listed.
Doxorubicin Liposome has been evaluated in one completed Phase 1 trial, NCT02260544, titled Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection. It enrolled 49 female participants aged 18 years and older in India and was active controlled and randomized.
Yes, Doxorubicin Liposome is also known as Doxorubicin Hydrochloride Liposome Injection. Both names refer to the same liposomal formulation of doxorubicin developed by Dr. Reddy's Laboratories Ltd for recurrent ovarian epithelial cancer.