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Also known as SCH 200746
Pegylated Lyposomal Doxorubicin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | Caelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2 |
| Name | Type | Description |
|---|---|---|
| Pegylated Lyposomal Doxorubicin | DRUG | Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy. |
| Cyclophosphamide | DRUG | Cyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy. |
Inclusion Criteria: * Female, aged \>=18 years. * Subject must have histologic diagnosis of breast carcinoma. * Subject must have documented measurable metastatic breast cancer by appropriate radiologic imaging. * Subject must have previous anthracyclin-based adjuvant regimen and disease-free statu...
Pegylated lyposomal doxorubicin is being studied for the treatment of breast neoplasm, specifically metastatic breast cancer. It is an oncology drug candidate developed by Merck & Company, Inc. under ticker MRK. The clinical program has evaluated it in combination with cyclophosphamide in female patients aged 18 years and older.
Pegylated lyposomal doxorubicin targets F8, which is classified as an exogenous protein target. This target association places the drug within an oncology development program focused on breast neoplasm. The drug is formulated as a small molecule and is being developed by Merck & Company, Inc. (MRK).
Pegylated lyposomal doxorubicin is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is the sponsor behind the clinical program evaluating this oncology asset in breast neoplasm. The development effort includes a Phase 2 study conducted in patients with metastatic breast cancer.
Pegylated lyposomal doxorubicin is in Phase 2 development. It is an investigational agent and is not approved. The Phase 2 program includes one completed trial with a total enrollment of 70 patients. No active trials are currently listed for this drug candidate.
Pegylated lyposomal doxorubicin has been evaluated in the Phase 2 trial NCT00779129, titled A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948). The trial enrolled 70 female patients aged 18 years and older and is now completed. It was an uncontrolled study without randomization or double blinding.
Yes, pegylated lyposomal doxorubicin is also known as Caelyx. The Phase 2 trial NCT00779129 refers to the drug by the name Caelyx in its title, evaluating it in combination with cyclophosphamide for metastatic breast cancer. Both names refer to the same Merck & Company, Inc. oncology asset.