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JNJ-26854165

Phase 1

Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Mar 26, 2010

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 Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00676910A Research Study of JNJ-26854165 to Determine the Safety and Dose in Patients With Advanced Stage or Refractory Solid Tumors.PHASE1 COMPLETED 71Nov 1, 2006Feb 1, 2010Mar 26, 2010 -
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Study Endpoints
Primary Endpoints
Determine the safety of JNJ-26854165 and the maximum tolerated dose in patients with advanced stage or refractory solid tumors.
Secondary Endpoints
Determine how JNJ-26854165 is absorbed, broken down and eliminated and the effect of food on these processes. Explore how JNJ-26854165 effects the body and the disease.Determine how JNJ-26854165 interacts with other specific drugs.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
JNJ-26854165DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Confirmed solid malignancy, in advanced, incurable stage or not responsive to available therapies * performance status (based on the Eastern Cooperative Oncology Group assessments) of \<= 2 * life expectancy \> 3 months * must consent to skin biopsies * must meet protocol-defi...

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