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R306465

Phase 1

Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Apr 27, 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 Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00677001A Research Study to Evaluate the Safety of R306465, a Drug in Development for Cancer and to Study the Absorption, Break Down and Elimination in Patients With Advanced Solid Malignancies.PHASE1 COMPLETED 15Sep 1, 2005Oct 1, 2006Apr 27, 2010 -
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Study Endpoints
Primary Endpoints
Determine the safety and maximum tolerated dose of R306465 when given as a daily oral dose during 3 weeks followed by a 1 week recovery period. Study the absorption, break down and elimination of R306465 following oral administration.
Secondary Endpoints
Investigate the effect of food on oral administration of R306465. Evaluate the antitumor activity of R306465 in patients with measurable cancer.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
R306465DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Confirmed solid malignancy that is metastatic or unresectable, and for which standard curative or palliative measures does not exist or are no longer effective * Performance status (based on the Eastern Cooperative Oncology Group assessments) of \<= 2 * Life expectancy \> 3 mo...

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