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epirubicin

Phase 2

Testicular Neoplasms | Small molecule | Oncology |Baxter International Inc.|Last Updated: Feb 25, 2011

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00231582High-dose Chemotherapy With Autologous Stem Cell Transplantation in Poor Prognosis Germ-cell Tumors: TAXIF IIPHASE2 COMPLETED 50Sep 1, 2004Jan 1, 2010Feb 25, 20111 France
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Study Endpoints
Primary Endpoints
Complete response rate
during de study
Secondary Endpoints
Survival (overall and progression-free), toxicity, toxic-death rate.
during the study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL1
Interventions
NameTypeDescription
epirubicinDRUGepirubicin
high-dose and autologous stem cell transplantationPROCEDUREhigh-dose and autologous stem cell transplantation
paclitaxelDRUGpaclitaxel
etoposideDRUGetoposide
ifosfamideDRUGifosfamide
carboplatinDRUGcarboplatin
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Eligibility requirements includes the following criteria: * Age \>18 years and \< 65 * Performance status \< 3 * Histologically or biologically documented GCTs * Testicular, abdominal, or mediastinal tumors * Measurable or evaluable disease * Life expectancy \> 3 months * Norma...

Countries:France
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