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pegylated liposomal doxorubicin

Phase 2

Epithelial Ovarian Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 26, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment297

FDA Designations

No designations recorded

Clinical trial landscape

pegylated liposomal doxorubicin · 1 trial · 3 indications

Phase 2 1
NCT01666444VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal CancerEpithelial Ovarian Cancer
COMPLETED297 Analytics
PHASE2COMPLETED
VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Epithelial Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival
Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.

Comparison of duration of survival between the 2 treatment groups

Secondary Endpoints

Progression-free Survival (PFS)
Progression-free survival is measured from enrollment and randomization on the study until first indication of progression based on irRECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment.
Frequency and Severity of Adverse Events (AEs)
Assessed during each cycle of therapy and within 30 days after the last cycle of therapy
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PLD 40 mg/m2 plus VTX-2337EXPERIMENTALThe dosing schedule will be be based on a 28-day cycle. The starting dose schedule is PLD on Day 1 plus VTX-2337 on Day 3, Day 10, and Day 17 for the first 4 cycles. Starting with cycle 5, the dose regimen will be PLD on Day 1 plus VTX-2337 on Day 3 only, without additional doses of VTX-2337 on Days 10 and Day 17.
PLD 40 mg/m2 plus placeboACTIVE_COMPARATORThe dosing schedule will be based on a 28-day cycle. The starting dose schedule is PLD on Day 1 plus placebo on Day 3, Day 10, and Day 17 for the first 4 cycles. Starting with cycle 5, the dose regimen will be PLD on Day 1 plus placebo on Day 3 only.

Interventions

NameTypeDescription
pegylated liposomal doxorubicin (PLD)DRUG -
VTX-2337DRUGTLR8 Agonist
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites136

Inclusion Criteria: 1. Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. 2. Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated car...

Countries:United States
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Frequently asked questions about pegylated liposomal doxorubicin

What is pegylated liposomal doxorubicin used for in epithelial ovarian cancer?

Pegylated liposomal doxorubicin is used for the treatment of recurrent or persistent epithelial ovarian cancer, as well as fallopian tube cancer and primary peritoneal cancer. It is being studied in a Phase 2 clinical trial for these conditions.

Who makes pegylated liposomal doxorubicin?

Pegylated liposomal doxorubicin is developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the stock market.

What phase is pegylated liposomal doxorubicin in?

Pegylated liposomal doxorubicin is in Phase 2 clinical development for epithelial ovarian cancer. It is an investigational drug and has not yet been approved by regulatory authorities.

What clinical trials is pegylated liposomal doxorubicin in?

Pegylated liposomal doxorubicin is being studied in clinical trial NCT01666444, titled "VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer." This Phase 2 trial has been completed and enrolled 297 female participants aged 18 years and older in the United States.

Is pegylated liposomal doxorubicin a small molecule drug?

Yes, pegylated liposomal doxorubicin is classified as a small molecule drug. It is being investigated in the oncology therapeutic area for the treatment of epithelial ovarian cancer.