Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment

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NCT01473043

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Study Location
Pfizer Investigational Site
Douglas, Queensland, 4814, Australia
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Metastatic renal cell carcinoma with a component of clear cell subtype.

- Prior first line systemic therapy

- At least 1 measurable lesion as per Response Evaluation Criterion in Solid Tumors [RECIST 1.1].

- Adequate hematology, liver and kidney functions

- Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1.

- Life expectancy of ≥12 weeks.

- Normotensive or well controlled hypertension (less than/equal to 140/90 mm Hg.)

- Negative pregnancy test

- Adequate recovery time from prior systemic therapy, surgery or radiation

- Willing and able subjects who have signed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- More than one prior systemic therapy regimen


- Major bowel-penetrating surgery <4 weeks


- Active gastro intestinal bleed in past 3 months


- Active peptic ulcer disease in the past 6 months


- Current or anticipated use of potent CYP3A4/5 inhibitors


- Current or anticipated use of known CYP3A4/5 or CYP1A2 inducers


- Requirement for therapeutic warfarin or high dose steroids


- Symptomatic or untreated brain metastases


- A serious uncontrolled medical disorder or active infection


- Pregnant or breastfeeding females


- History of another active malignancy


- Dementia

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Advanced Information
Descriptive Information
Brief Title Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment
Brief Summary This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. The study will recruit a maximum of 30 patients from 2 countries including Australia and Canada. Patients will be followed up for efficacy, safety and health related outcomes.
Detailed Description Not Provided
Study Type Expanded Access
Intervention Drug: Axitinib
5mg twice daily [BD] daily dosing until progression or prohibitive toxicity Dose titration by 2 levels upwards (7mg and 10mg) and downwards (3mg and 2mg) allowed per protocol
Other Name: AG-013736
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01473043
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2014