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AZD4877

Phase 2

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

AZD4877 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Oct 2006

AZD4877 target and mechanism

Molecular targetKIF11
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment159

FDA Designations

No designations recorded

AZD4877 clinical trials

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 CancerUnlock trial analytics

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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Frequently asked questions about AZD4877

What is AZD4877?

AZD4877 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for the treatment of cancer. It has been studied in solid tumors and advanced bladder cancer, including transitional cell bladder cancer and cancers of the urethra, ureter, and renal pelvis. It is not an approved therapy and remains in clinical development.

What is AZD4877 used for in bladder cancer?

AZD4877 was studied in a Phase 2 trial in advanced bladder cancer, including transitional cell bladder cancer and cancers of the urethra, ureter, and renal pelvis. That study, NCT00661609, enrolled 54 patients across the United States, Canada, Germany, Spain, and the United Kingdom and has been completed.

What does AZD4877 target?

AZD4877 targets KIF11, a kinesin motor protein, and acts as an inhibitor of that target. KIF11 inhibition interferes with mitotic spindle function, which is why AZD4877 is described as an anti-mitotic agent. This mechanism is what supports its investigation in solid tumors and bladder cancer.

Who makes AZD4877?

AZD4877 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical program for the drug, including the Phase 2 bladder cancer study and the Phase 1 solid tumor and Japanese dose-escalation studies.

What phase is AZD4877 in?

AZD4877 reached Phase 2 in its clinical development. It is an investigational agent and is not an approved medicine. The Phase 2 study in advanced bladder cancer has been completed, and no trials of AZD4877 are currently active.

What clinical trials is AZD4877 in?

AZD4877 has been evaluated in three completed trials: NCT00661609, a Phase 2 study in advanced bladder cancer with 54 patients; NCT00613652, a Phase 1 dose-escalation study in Japanese adults with cancer; and NCT00389389, a Phase 1 dose-escalation study in solid tumors with 75 patients.