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Gimatecan

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Dec 19, 2020

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 Trials3
Total Enrollment51
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00487058A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid TumorsPHASE1 COMPLETED 28May 1, 2007 -Nov 19, 20091 Japan
NCT00441610An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid TumorPHASE1 COMPLETED 4Jan 1, 2007 -Dec 19, 20201 Japan
NCT00410358A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.PHASE1 COMPLETED 19Jun 1, 2006 -Dec 19, 20201 Japan
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Study Endpoints
Primary Endpoints
Safety and tolerability assessed by Adverse Events Characterization of the pharmacokinetic profile of gimatecan Anti-tumor activity assessed by Response Evaluation Criteria in Solid Tumors RECIST)
Safety and tolerability assessed by Adverse Events
2.8 years
Anti-tumor activity assessed by RECIST criteria
2.8 years
Estimated Maximum Tolerated Dose of gimatecan
1.8 years
Secondary Endpoints
Safety assessed by adverse events
1.8 years
Characterization of the pharmacokinetic profile of gimatecan
1.8 years
Anti-tumor activity assessed by RECIST
1.8 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GimatecanEXPERIMENTAL -
LBQ707EXPERIMENTAL -
Interventions
NameTypeDescription
GimatecanDRUG -
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria * Patients with histological or cytological confirmed advanced solid tumors, which progressed despite standard therapy or for whom no standard therapy exists * Life expectancy of at least 3 months * No dysfunction of bone marrow * No major impairment of renal and hepatic function...

Countries:Japan
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