Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment
NCT01473043
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Adult Trials: 18+ Years
- 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
- 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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| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2014 | |||