Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Clear Cell Renal Carcinoma

In brief

The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.

Key facts

Study ID

NCT01599754

Run by

SFJ Pharma Ltd. II

People needed

724

Starts

2012-04-01

Expected to finish

2018-05-01

Last updated by the study team

2019-09-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be treated by nephrectomy and patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
• Patients must have no evidence of macroscopic residual disease or metastatic disease.
• Male or female, age >=18 years (age >=20 years in Japan, Korea and Taiwan).
• Patients must be diagnosed with one of the following based on American Joint Committee on Cancer (AJCC) TNM staging version 2010, Eastern Collaborative Oncology Group (ECOG) performance status (PS):
• pT2, pN0 or pNx, M0 and ECOG PS 0-1
• pT3, pN0 or pNx, M0 and ECOG PS 0-1
• pT4, pN0 or pNx, M0 and ECOG PS 0-1
• Any pT, pN1, M0 and ECOG PS 0-1
• Patients must have histologically confirmed preponderant, defined as >50%, clear cell RCC.
• Patients must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) treatment for RCC.
• Patients must not have received any previous anti angiogenic treatment.
• Patients must have adequate organ function.

You may not qualify if…

• Histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma, lymphoma, or patients with any metastatic renal sites.
• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage <4 weeks of date of randomization.
• Diagnosis of any non-RCC malignancy within the 5 years from date of randomization, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months.
• Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
• Gastrointestinal abnormalities

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Palo Alto, California, United States
• Study site — Pleasant Hill, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Ocala, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Annapolis, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Omaha, Nebraska, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — New York, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Charleston, South Carolina, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Bedford, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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