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AZD4877

Phase 2

Bladder Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 12, 2011

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 Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00661609A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder CancerPHASE2 COMPLETED 54 — — May 1, 2008Dec 1, 2009Jan 12, 201136 United States, Canada +3
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)

Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).

Secondary Endpoints
Disease Control Rate (DCR)
8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)
Duration of Objective Tumor Response (OTR)
Time from first documentation of Complete or Partial Response, whichever occurs earlier, to discontinuation of the study drug (maximum treatment period of 309 days (44 weeks)
Progression Free Survival (PFS)
Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD4877EXPERIMENTALSingle agent AZD4877
Interventions
NameTypeDescription
AZD4877DRUGIntravenous (IV)25mg/weekly
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra). * Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy * Must have had a maximum of 2 prior chemotherapeutic regim...

Countries:United StatesCanadaGermanySpainUnited Kingdom
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Competitive Landscape -Bladder Cancer 147 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN15PHASE3Durvalumab, Bacillus Calmette-Guerin, Tremelimumab, Enfortumab Vedotin, Cisplatin
Bristol-Myers Squibb CompanyBMY5PHASE3Nivolumab, Gemcitabine, Cisplatin, Ipilimumab, Carboplatin
Johnson & JohnsonJNJ13PHASE3TAR-200, Mitomycin C, Gemcitabine, Cetrelimab, BCG Vesiculture
Merck & Co., Inc.MRK13PHASE3Pembrolizumab, BCG, Cisplatin, Fluorouracil, Mitomycin C
Pfizer Inc.PFE10PHASE3PF-06801591, Bacillus Calmette-Guerin, Avelumab, Lorlatanib, Talazoparib
Eli Lilly and CompanyLLY4PHASE3Vepugratinib, EV, Pembrolizumab, LY4101174, LY4052031
UroGen Pharma Ltd.URGN4PHASE3UGN-103, UGN-102, UGN-104, Jelmyto for pyelocalyceal
Natera, Inc.NTRA2PHASE3Atezolizumab
CG Oncology, Inc.CGON2PHASE3Cretostimogene Grenadenorepvec
Protara Therapeutics, Inc.TARA2PHASE3TARA-002
Relmada Therapeutics IncRLMD2PHASE3NDV-01, NDV01 intravesical controlled release formulation of gemcitabine and docetaxel
ImmunityBio IncIBRX6PHASE2N-803 and BCG, N-803 + Pembrolizumab, BCG + N-803, Intravesical Recombinant Mycobacterium, N803 plus Bacillus Calmette-Guerin
BeOne Medicines Ltd. Sponsored ADRONC3PHASE3Tislelizumab, Cisplatin, Gemcitabine, Carboplatin, BGB-A445
Exelixis, Inc.EXEL4PHASE2Cabozantinib, Atezolizumab, Zanzalintinib, cabozantinib, atezolizumab
Gilead Sciences, Inc.GILD2PHASE2Sacituzumab Govitecan-hziy, Pembrolizumab, Cisplatin, Avelumab, Zimberelimab
Tyra Bioscience, IncTYRA3PHASE2Dabogratinib, Dabogratinib TBD, TYRA-300, TYRA-300 Dose TBD
BioNTech SE Sponsored ADRBNTX1PHASE2Autogene Cevumeran, Nivolumab, Saline
ICON PlcICLR1PHASE3padeliporfin VTP
AbbVie, Inc.ABBV1PHASE2Livmoniplimab, Budigalimab, Docetaxel, Paclitaxel, Gemcitabine
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
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