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Zoledronate

Phase 2

Kidney Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Mar 18, 2013

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 Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00490698Zoledronate With Atorvastatin in Renal Cell CarcinomaPHASE2 COMPLETED 11Oct 1, 2006Jan 1, 2012Mar 18, 20131 United States
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Study Endpoints
Primary Endpoints
Median Time to First Skeletal-related Event
Up to 1 year

Time to skeletal events, defined as a metastatic site requiring radiotherapy or any surgical intervention (eg, embolization, radiofrequency ablation, intrathecal catheter placement) or complications from skeletal metastatic lesions (eg, pathologic fracture, spinal cord compression). Time to skeletal events monitored every 8 weeks for at least 1 year.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Zoledronate + AtorvastatinEXPERIMENTALZoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
Interventions
NameTypeDescription
ZoledronateDRUG4 mg IV Once Every 4 Weeks
AtorvastatinDRUG20 mg PO Daily
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically confirmed renal cell carcinoma 2. Must have evidence of predominant bone metastases on X-rays, bone scan, MRI or CT scan. No requirement for bidimensionally measurable lesions. 3. Impending complications (such as pathological fractures and spinal cord compressi...

Countries:United States
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Competitive Landscape -Kidney Cancer 114 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3Nivolumab and rHuPH20, Nivolumab, Ipilimumab, Cabozantinib, Sunitinib
Merck & Co., Inc.MRK19PHASE3Pembrolizumab, Belzutifan, Lenvatinib, Everolimus, Cabozantinib
AstraZeneca PLCAZN8PHASE3Savolitinib, Sunitinib, Volrustomig, Casdatifan, Nivolumab
Exelixis, Inc.EXEL8PHASE3XL092, Nivolumab, Sunitinib, Cabozantinib, Ipilimumab
Arcus Biosciences, Inc.RCUS3PHASE3Casdatifan, Cabozantinib, AB598, Zimberelimab, Fluorouracil
Telix Pharmaceuticals Limited Sponsored ADRTLX3PHASE389Zr-TLX250 PET/CT, 177Lu-TLX250 and Peposertib
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Fianlimab, Ipilimumab, Nivolumab, Cemiplimab, Pexastimogene Devacirepvec
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2/PHASE3fruquintinib+sintilimab, axitinib / everolimus
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
Actuate Therapeutics, Inc.ACTU1PHASE29-ING-41, Gemcitabine - 21 day cycle, Doxorubicin., Lomustine, Carboplatin.
Apollomics Inc. Class AAPLM1PHASE2APL-101
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed /m2, Cisplatin /m2
Syndax Pharmaceuticals IncSNDX1PHASE2Entinostat, Interleukin-2
Pfizer Inc.PFE1PHASE1PF-08634404, Ipilimumab, Axitinib
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Rein Therapeutics, IncRNTX1PHASE3Nivolumab, Ipilimumab, Pembrolizumab, Cabozantinib, Axitinib
Nanobiotix SA Sponsored ADRNBTX1PHASE1NBTXR3, Nivolumab, Pembrolizumab
Psyence Biomedical Ltd.PBM1PHASE2Psilocybin therapy
Janux Therapeutics, Inc.JANX1PHASE1JANX008
Kura Oncology, Inc.KURA1PHASE1Darlifarnib, Cabozantinib, Adagrasib
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