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

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Douglas, Queensland, 4814 Australia
Contact
1-800-718-1021
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.
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- 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.
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- More than one prior systemic therapy regimen

- Major bowel-penetrating surgery

- 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

NCT01473043
Pfizer
No longer available
Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment

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[email protected]

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