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S-1, Bevacizumab

Phase 2

Colorectal Cancer | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Nov 2, 2012

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00569699Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)PHASE2 COMPLETED 56Oct 1, 2007Mar 1, 2011Nov 2, 20121 Japan
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Study Endpoints
Primary Endpoints
Progression free survival
every course for first three courses, then every other course
Secondary Endpoints
Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation
any time
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALS-1, Bevacizumab
Interventions
NameTypeDescription
S-1, BevacizumabDRUGS-1 is administered orally on days 1 to 28 of a 42-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA \<1.25 m2), 50 mg (BSA \>1.25 to \<1.50 m2), or 60 mg (BSA \>1.50 m2). Bevacizumab 5 mg/kg (body weight) is administered by intravenous infusion on days 1, and 15.
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy 2. Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) 3. Pa...

Countries:Japan
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Competitive Landscape -Colorectal Cancer 263 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV8PHASE3Telisotuzumab Adizutecan, Telisotuzumab adizutecan, Bevacizumab, Trifluridine/Tipiracil, ABBV-400
Bristol-Myers Squibb CompanyBMY7PHASE3Ipilimumab, Oxaliplatin, Leucovorin, Fluorouracil, Irinotecan
Merck & Co., Inc.MRK6PHASE3Pembrolizumab, Oxaliplatin, Leucovorin, 5-fluorouracil, Irinotecan
Johnson & JohnsonJNJ5PHASE3Amivantamab, Cetuximab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, Oxaliplatin
Pfizer Inc.PFE12PHASE3PF-08634404, Bevacizumab, Chemotherapy, tucatinib, trastuzumab
GSK plc Sponsored ADRGSK6PHASE3Dostarlimab, CAPEOX, FOLFOX, GSK4418959, PD-1 inhibitor
Exelixis, Inc.EXEL5PHASE3XL092, Atezolizumab, Regorafenib, cabozantinib, atezolizumab
Summit Therapeutics IncSMMT3PHASE3Drug: Ivonescimab, Drug: Bevacizumab, AK112, AK117, Oxaliplatin
Natera, Inc.NTRA4PHASE3Capecitabine, Oxaliplatin, Folfirinox, FOLFOX regimen
Agenus Inc.AGEN4PHASE3Balstilimab, Botensilimab, CR6086, AGEN2034
Incyte CorporationINCY2PHASE3INCA33890, Bevacizumab, FOLFOX, Ruxolitinib, Capecitabine
Amgen Inc.AMGN1PHASE3FOLFIRI Regimen, Sotorasib, Panitumumab, Bevacizumab-awwb
Eli Lilly and CompanyLLY8PHASE2LY2157299, Capecitabine, Fluorouracil, LY4066434., Cetuximab
AstraZeneca PLCAZN8PHASE2Datopotamab deruxtecan, Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE2fruquintinib, FOLFIRI, oxaliplatin , levofolinate calcium , 5-FU, panitumumab, mFOLFOX6 + panitumumab combination therapy
Novartis AG Sponsored ADRNVS7PHASE2Dabrafenib, Trametinib, JDQ443, TNO155, tislelizumab
BioNTech SE Sponsored ADRBNTX3PHASE2RO7198457, PM8002, Chemotherapy Regimen 1, BNT314, BNT327
Regeneron Pharmaceuticals, Inc.REGN2PHASE2Cemiplimab + Fianlimab, VV1, Cemiplimab
Revolution Medicines, Inc.RVMD7PHASE1RMC-6291, Elironrasib, Daraxonrasib, RMC-9805, RMC-6236
Veracyte, Inc.VCYT1PHASE3Tislelizumab
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