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Pegylated Lyposomal Doxorubicin

Phase 2

Breast Neoplasm | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Sep 30, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

Pegylated Lyposomal Doxorubicin · 1 trial · 1 indication

Phase 2 1
NCT00779129A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)Breast Neoplasm
COMPLETED70 Analytics
PHASE2COMPLETED
A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)
Breast NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to response; Duration of response; Time to progression; Survival
With complete or partial response, subjects will be re-evaluated 4 weeks later to confirm the initial observation; Follow-up for a minimum of one year for survival.

Secondary Endpoints

Left ventricular ejection fraction (LVEF), (MUGA Scan); Radiological imaging; Examination of adverse events, laboratory data, vital signs
LVEF following cycles 2, 4, 5, and 6 of study drug; Radiological imaging every 6 weeks.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmEXPERIMENTALCaelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2

Interventions

NameTypeDescription
Pegylated Lyposomal DoxorubicinDRUGCaelyx 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.
CyclophosphamideDRUGCyclophosphamide 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.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexFEMALE
Healthy VolunteersNo

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...

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Frequently asked questions about Pegylated Lyposomal Doxorubicin

What is Pegylated Lyposomal Doxorubicin used for?

Pegylated Lyposomal Doxorubicin is used for the treatment of breast neoplasm, specifically in combination with cyclophosphamide for metastatic breast cancer. It is an investigational small molecule being studied in oncology. The drug is currently in Phase 2 clinical development.

Who makes Pegylated Lyposomal Doxorubicin?

Pegylated Lyposomal Doxorubicin is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating breast cancer.

What phase is Pegylated Lyposomal Doxorubicin in?

Pegylated Lyposomal Doxorubicin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed to evaluate its use in metastatic breast cancer.

What clinical trials is Pegylated Lyposomal Doxorubicin in?

Pegylated Lyposomal Doxorubicin has one completed clinical trial, NCT00779129, titled 'A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)'. This Phase 2 trial enrolled 70 female participants aged 18 years and older.

Is Pegylated Lyposomal Doxorubicin the same as Caelyx?

Yes, Pegylated Lyposomal Doxorubicin is also known as Caelyx. The clinical trial NCT00779129 refers to the drug as Caelyx in its title, confirming that these names refer to the same investigational agent.