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Aroplatin

Phase 1

Malignancies | Small molecule | Oncology |Agenus Inc.|Last Updated: Oct 27, 2008

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 Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00316511Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell LymphomaPHASE1 COMPLETED 21Mar 1, 2006 -Oct 27, 20082 United States
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Study Endpoints
Primary Endpoints
Determine the maximum tolerated dose and dose-limiting toxicity of L-NDDP
Assess safety of L-NDDP
Determine the pharmacokinetic profile of L-NDDP
Secondary Endpoints
Assess clinical activity
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
AroplatinDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Advanced solid malignancies or B-cell lymphoma 2. Less than or equal to 5 anti-cancer treatment regimens, which must be concluded at least four weeks prior to the first planned L-NDDP administration 3. Measurable disease 4. Eastern Cooperative Oncology Group (ECOG) performanc...

Countries:United States
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