Recent Updates
Recently added Catalysts

pegylated liposomal doxorubicin

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment297
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01666444VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal CancerPHASE2 COMPLETED 297 — — Oct 31, 2012Jul 31, 2016Sep 26, 2019136 United States
Unlock Drug Trial Details
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
Unlock Study Endpoints
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 -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria