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JNJ-26481585

Phase 1

Lymphoma | Small molecule | Oncology |Johnson & Johnson|Last Updated: Sep 17, 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 Enrollment92
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00677105A Safety and Dose-finding Study of JNJ-26481585 for Patients With Advanced Solid Malignancies and Lymphoma.PHASE1 COMPLETED 92 — — Aug 1, 2007Sep 1, 2011Sep 17, 20126 United Kingdom
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Study Endpoints
Primary Endpoints
Determine the safety and the maximum tolerated dose of JNJ-26481585. Determine how JNJ-26481585 and its metabolite, JNJ-26395018, are absorbed, broken down and eliminated after oral administration
Secondary Endpoints
Investigate the effect of food on the absorption, break down and elimination of JNJ-26481585 and its metabolite, JNJ-26395018. Monitor the antitumor activity of JNJ-26481585.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
JNJ-26481585DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

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

Countries:United Kingdom
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Competitive Landscape -Lymphoma 345 trials
CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Eli Lilly and CompanyLLY13PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab, Ibrutinib
Merck & Co., Inc.MRK16PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
AstraZeneca PLCAZN15PHASE3Surovatamig, R-CHOP, R-CVP, BR, AZD0486
Novartis AG Sponsored ADRNVS8PHASE3Tisagenlecleucel, Lenalidomide and rituximab in 28-day cycles for up to 12 cycles., Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone in 21-day cycles for 6 to 8 cycles, Lymphodepleting chemotherapy, CTL019
Incyte CorporationINCY16PHASE3Tafasitamab, Lenalidomide, tafasitamab, rituximab, lenalidomide
BeOne Medicines Ltd. Sponsored ADRONC21PHASE3Zanubrutinib, Bendamustine, Rituximab, Venetoclax, Tislelizumab
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab
AbbVie, Inc.ABBV11PHASE3Venetoclax, Loncastuximab Tesirine and Epcoritamab, Venetoclax; Rituximab, DRC, Obinutuzumab
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab, Rituximab, Lenalidomide, Oxaliplatin, Gemcitabine
Bristol-Myers Squibb CompanyBMY18PHASE3Azacitidine, Romidepsin, Gemcitabine, Golcadomide, Rituximab
Johnson & JohnsonJNJ11PHASE3Ibrutinib, Ibrutinib / Bortezomib / Rituximab, Venetoclax, JNJ-90009530, JNJ-80948543
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Lenalidomide, Gemcitabine, Dexamethasone
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, Pirtobrutinib, venetoclax, rituximab, obinutuzumab
ADC Therapeutics LtdADCT4PHASE3Loncastuximab Tesirine, Rituximab, Gemcitabine, Oxaliplatin, Cyclophosphamide
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib, Belinostat, Pralatrexate, CPI-818
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760, R-GemOx, HMPL-760 planned dose 1
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib, Alectinib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK8PHASE2Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone, TAK-007
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