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Clinical Study With Axitinib (AG 013736) In Patients With Metastatic Renal Cell Carcinoma After Failure Of One Prior Systemic First-Line Therapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

Clinical Study With Axitinib (AG 013736) In Patients With Metastatic Renal Cell Carcinoma After Failure Of One Prior Systemic First-Line Therapy


Inclusion Criteria:



- 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:

- 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

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4061061

NCT ID:

NCT01473043

Start Date:

March 2012

Completion Date:

January 2014

Related Keywords:

  • Renal Cell Carcinoma
  • Axitinib
  • metastatic renal cell carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

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