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NCT00661609 · REGISTRY CONDITION SEARCH

A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2011-01-12

The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth), can reduce tumor sizes in patients with bladder cancer

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)

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outcome · POSTED

Disease Control Rate (DCR)

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outcome · NOT POSTED

Duration of Objective Tumor Response (OTR)

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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 regimens, one for unremovable and/or metastasized disease, and the other in the adjuvant or neo-adjuvant setting. * Ambulatory and capable of all selfcare more than 50% of waking hours Exclusion Criteria: * Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study medication; 6 weeks if prior systemic mitomycin, nitrosourea, or suramin. * Inadequate bone marrow reserve * Inadequate liver function in the presence of liver metastases * Impaired renal function
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Single agent AZD4877
    intervention Names
    1. Drug: AZD4877
    label
    AZD4877
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. AZD4877
    description
    Intravenous (IV)25mg/weekly
    name
    AZD4877
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
54
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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).
    measure
    Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
    time Frame
    8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)
secondary Outcomes
  1. description
    Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).
    measure
    Disease Control Rate (DCR)
    time Frame
    8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)
  2. description
    Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)
    measure
    Duration of Objective Tumor Response (OTR)
    time Frame
    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)
  3. description
    Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.
    measure
    Progression Free Survival (PFS)
    time Frame
    Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
  4. description
    Time in weeks from the first administration of study drug to death.
    measure
    Overall Survival (OS)
    time Frame
    Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)
Full study description
brief Summary
The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth), can reduce tumor sizes in patients with bladder cancer
Source references
references
  1. citation
    Jones R, Vuky J, Elliott T, Mead G, Arranz JA, Chester J, Chowdhury S, Dudek AZ, Muller-Mattheis V, Grimm MO, Gschwend JE, Wulfing C, Albers P, Li J, Osmukhina A, Skolnik J, Hudes G. Phase II study to assess the efficacy, safety and tolerability of the mitotic spindle kinesin inhibitor AZD4877 in patients with recurrent advanced urothelial cancer. Invest New Drugs. 2013 Aug;31(4):1001-7. doi: 10.1007/s10637-013-9926-y. Epub 2013 Jan 18.
    pmid
    23329066
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-8ee210c9841ff67cb14b
      requested nct id
      NCT00661609
      primary nct id
      NCT00661609
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      308f79635904744c3081b7bece1bbf864685110f5917c0840a211e0e58d7fefc
      payload sha256
      e272735d1a46c20e0da911a2fea3a0fba10ea5371619c915b3c8498ea962c214
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-8ee210c9841ff67cb14b
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00661609
      occurrences
      1. context exact
        NCT00661609
        end
        11
        exact text
        NCT00661609
        start
        0
      offset unit
      unicode_code_points
      query cond
      Urethral Cancer
      query disease state id
      ds-urethral-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-urethral-cancer-000.json
      source file sha256
      308f79635904744c3081b7bece1bbf864685110f5917c0840a211e0e58d7fefc
      source json pointer
      /studies/20/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      be2117ee0698987d87b6f85fef8f5e3198f018d79c15c5bfdf6d683c2c7f2215

    Preserved source evidence · Not medical advice