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AZD4877

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

AZD4877 · 3 trials · 9 indications

Phase 2 1Phase 1 2
NCT00661609A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder CancerBladder Cancer
COMPLETED54 Analytics
PHASE2COMPLETED
A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer
Bladder Cancer
NCT0066160954
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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).

To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
weekly
To identify a maximum-tolerated dose of AZD4877 by assessment of the incidence of dose-limiting toxicities as measured by the Common Terminology Criteria for Adverse Events (CTCAE) grade and type of AEs experienced in the first cycle of treatment.
assessed at each treatment

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 to 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 KingdomJapan
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Competitive Landscape -Bladder Cancer 145 trials

Top 20 of 46 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN15PHASE3Durvalumab, Bacillus Calmette-Guerin
Bristol-Myers Squibb CompanyBMY5PHASE3Nivolumab, Gemcitabine, Cisplatin
Johnson & JohnsonJNJ12PHASE3TAR-200, Mitomycin C, Gemcitabine
Merck & Co., Inc.MRK14PHASE3Pembrolizumab, BCG
Pfizer Inc.PFE10PHASE3PF-06801591, Bacillus Calmette-Guerin
Eli Lilly and CompanyLLY4PHASE3Vepugratinib, EV, Pembrolizumab
Natera, Inc.NTRA2PHASE3Atezolizumab
UroGen Pharma Ltd.URGN4PHASE3UGN-103
CG Oncology, Inc.CGON2PHASE3Cretostimogene Grenadenorepvec
Protara Therapeutics, Inc.TARA2PHASE3TARA-002
Relmada Therapeutics IncRLMD2PHASE3NDV-01
BeOne Medicines Ltd. Sponsored ADRONC3PHASE3Tislelizumab, Cisplatin, Gemcitabine, Carboplatin
ImmunityBio IncIBRX6PHASE2N-803 and BCG
Exelixis, Inc.EXEL4PHASE2Cabozantinib, Atezolizumab
ICON PlcICLR1PHASE3padeliporfin VTP
Gilead Sciences, Inc.GILD2PHASE2Sacituzumab Govitecan-hziy, Pembrolizumab, Cisplatin, Avelumab, Zimberelimab
Tyra Bioscience, IncTYRA3PHASE2Dabogratinib, Dabogratinib TBD
BioNTech SE Sponsored ADRBNTX1PHASE2Autogene Cevumeran, Nivolumab
AbbVie, Inc.ABBV1PHASE2Livmoniplimab, Budigalimab, Docetaxel, Paclitaxel, Gemcitabine
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
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Frequently asked questions about AZD4877

What is AZD4877 used for?

AZD4877 is an investigational small molecule being studied for the treatment of bladder cancer and other cancers, including neoplasms and solid tumors. It was evaluated in clinical trials for advanced bladder cancer, including transitional cell bladder cancer, as well as cancers of the urethra, ureter, and renal pelvis.

Who is developing AZD4877?

AZD4877 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is an investigational oncology small molecule that has been studied in early-phase clinical trials.

What phase is AZD4877 in?

AZD4877 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug, meaning it is not approved for commercial use and remains in clinical development. The Phase 2 study evaluated the drug in patients with advanced bladder cancer.

What clinical trials has AZD4877 been in?

AZD4877 has been studied in three completed clinical trials. NCT00389389 was a Phase 1 dose-escalation study in solid tumors, NCT00613652 was a Phase 1 study in Japanese adult patients with cancer, and NCT00661609 was a Phase 2 study in advanced bladder cancer.

How does AZD4877 work?

AZD4877 is described as a novel anti-mitotic agent, meaning it is designed to interfere with cell division. It was studied as a potential treatment for cancer, including bladder cancer, based on its anti-mitotic properties.

Is AZD4877 the same as another drug?

AZD4877 is the primary name used in clinical trial records for this investigational drug. No alternative names have been reported in the clinical trial information available for this compound.