ID

4282

Description

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

Keywords

  1. 12/6/13 12/6/13 - Martin Dugas
Uploaded on

December 6, 2013

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility DRKS00004052 NCT00661609 Advanced Bladder Cancer

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

Alias
NCI Metathesaurus CUI
C1512693
Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra).
Description

Confirmed urothelial cancer

Data type

boolean

Alias
NCI Metathesaurus CUI
CL363966
Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
Description

Disease stage

Data type

boolean

Alias
NCI Metathesaurus CUI
C0474940
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.
Description

Chemotherapie

Data type

boolean

Alias
NCI Metathesaurus CUI
C1518470
Ambulatory and capable of all selfcare more than 50% of waking hours
Description

Selfcare

Data type

boolean

Alias
NCI Metathesaurus CUI
C0036592
Exclusion criteria
Description

Exclusion criteria

Alias
NCI Metathesaurus CUI
C0680251
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.
Description

Prior treatment

Data type

boolean

Alias
NCI Metathesaurus CUI
C1522449
NCI Metathesaurus CUI
C0949266
Inadequate bone marrow reserve
Description

Bone marrow

Data type

boolean

Alias
NCI Metathesaurus CUI
C0005953
Inadequate liver function in the presence of liver metastases
Description

Liver function

Data type

boolean

Alias
NCI Metathesaurus CUI
C0232744
Impaired renal function
Description

Renal function

Data type

boolean

Alias
NCI Metathesaurus CUI
C0341697

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
C1512693 (NCI Metathesaurus CUI)
Confirmed urothelial cancer
Item
Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra).
boolean
CL363966 (NCI Metathesaurus CUI)
Disease stage
Item
Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
boolean
C0474940 (NCI Metathesaurus CUI)
Chemotherapie
Item
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.
boolean
C1518470 (NCI Metathesaurus CUI)
Selfcare
Item
Ambulatory and capable of all selfcare more than 50% of waking hours
boolean
C0036592 (NCI Metathesaurus CUI)
Item Group
Exclusion criteria
C0680251 (NCI Metathesaurus CUI)
Prior treatment
Item
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.
boolean
C1522449 (NCI Metathesaurus CUI)
C0949266 (NCI Metathesaurus CUI)
Bone marrow
Item
Inadequate bone marrow reserve
boolean
C0005953 (NCI Metathesaurus CUI)
Liver function
Item
Inadequate liver function in the presence of liver metastases
boolean
C0232744 (NCI Metathesaurus CUI)
Renal function
Item
Impaired renal function
boolean
C0341697 (NCI Metathesaurus CUI)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial