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Platinol

Phase 1

Carcinoma, Transitional Cell | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Aug 29, 2006

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00101842Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder CancerPHASE1 COMPLETED 61 — — Dec 1, 2004Jul 1, 2006Aug 29, 20061 United States
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Study Endpoints
Primary Endpoints
Toxicity will be measured by standard grading methods.
Secondary Endpoints
Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).
Duration of response is defined as time from first objective assessment of CR or PR to first time of progression or death from any cause.
Time to progressive disease is defined as time from enrollment to first date of disease progression.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
PemetrexedDRUG -
GemcitabineDRUG -
PlatinolDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Biopsy-proven metastatic bladder cancer * No prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment * Prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enr...

Countries:United States
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