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liposomal doxorubicin

Phase 3

Genital Neoplasms, Female | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jan 26, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment162
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00191607A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.PHASE3 COMPLETED 162Jul 1, 2002Nov 1, 2005Jan 26, 20071 United States
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Study Endpoints
Primary Endpoints
- Progression free survival (PFS) in patients who have failed one, but no more than two, prior treatments
Secondary Endpoints
Secondary objectives:
Response rate
Duration of response
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
GemcitabineDRUG -
liposomal doxorubicinDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * All patients must have a documented pathologic diagnosis of epithelial ovarian (FIGO Stage I-IV), Fallopian tube or primary peritoneal carcinoma * Patients must have received platinum-based, first-line chemotherapy but no more than one additional prior chemotherapy regimen. Pa...

Countries:United States
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