ID

44718

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 see http://clinicaltrials.gov/ct2/show/study/NCT00661609

Link

http://clinicaltrials.gov/ct2/show/study/NCT00661609

Keywords

  1. 11/21/11 11/21/11 -
  2. 3/27/14 3/27/14 - Martin Dugas
  3. 9/17/21 9/17/21 -
  4. 9/27/21 9/27/21 - Sarah Riepenhausen
Copyright Holder

AstraZeneca

Uploaded on

September 27, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0

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.

A Phase II Study of AZD4877 (a Novel Anti-mitotic DRKS00004052

Eligibility Bladder Cancer NCT00661609

Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI [1]
C1512693
Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra).
Description

Urothelial cancer

Data type

boolean

Alias
UMLS CUI [1]
C1519840
Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
Description

Stage IV

Data type

boolean

Alias
UMLS CUI-1
C0441772
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

Prior chemotherapy

Data type

boolean

Alias
UMLS CUI-1
C1514457
Ambulatory and capable of all selfcare more than 50% of waking hours
Description

Selfcare

Data type

boolean

Alias
UMLS CUI-1
C0036592
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI [1]
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
UMLS CUI-1
C1514463
Inadequate bone marrow reserve
Description

Bone marrow

Data type

boolean

Alias
UMLS CUI-1
C0005953
Inadequate liver function in the presence of liver metastases
Description

Liver function

Data type

boolean

Alias
UMLS CUI
C0232744
Impaired renal function
Description

Renal function

Data type

boolean

Alias
UMLS CUI
C1565489

Similar models

Eligibility Bladder Cancer NCT00661609

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI [1])
Urothelial cancer
Item
Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra).
boolean
C1519840 (UMLS CUI [1])
Stage IV
Item
Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
boolean
C0441772 (UMLS CUI-1)
Prior chemotherapy
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
C1514457 (UMLS CUI-1)
Selfcare
Item
Ambulatory and capable of all selfcare more than 50% of waking hours
boolean
C0036592 (UMLS CUI-1)
Item Group
Exclusion criteria
C0680251 (UMLS CUI [1])
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
C1514463 (UMLS CUI-1)
Bone marrow
Item
Inadequate bone marrow reserve
boolean
C0005953 (UMLS CUI-1)
Liver function
Item
Inadequate liver function in the presence of liver metastases
boolean
C0232744 (UMLS CUI)
Renal function
Item
Impaired renal function
boolean
C1565489 (UMLS 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