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Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients (ATLAS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
SFJ Pharmaceuticals, Inc. Identifier:
First received: May 11, 2012
Last updated: May 11, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Clear Cell Renal Carcinoma
Drug: Axitinib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adjuvant Axitinib Treatment of Renal Cancer: A Randomized Double-blind Phase 3 Study of Adjuvant Axitinib vs. Placebo in Subjects at High Risk of Recurrent RCC

Resource links provided by NLM:

Further study details as provided by SFJ Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Disease Free Survival (DFS) [ Time Frame: 5 years ]
    To demonstrate an improvement in disease free survival (DFS) in patients at high risk of recurrent RCC randomly assigned to adjuvant axitinib (Arm A) vs. Placebo (Arm B) after nephrectomy.

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 5 years ]
    Compare Overall Survival (OS) associated with Arm A to that associated with Arm B. OS defined as the time from the date of randomization to the date of death due to any cause.

  • Safety [ Time Frame: 5 years ]
    Assess safety profile of Arm A to Arm B. Assessment of adverse events will include: type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0), timing, seriousness, and relatedness; and laboratory abnormalities.

Estimated Enrollment: 700
Study Start Date: April 2012
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Axitinib Drug: Axitinib
Axitinib 5 mg twice daily
Other Name: Inlyta
Placebo Comparator: Placebo Drug: Placebo
Placebo twice daily

Detailed Description:

This is a prospective, randomized, double blind placebo controlled Phase 3 trial of oral axitinib starting at 5 mg twice daily given 3 years vs. placebo.

Approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients must be treated by nephrectomy and patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

  1. Patients must have no evidence of macroscopic residual disease or metastatic disease.
  2. Male or female, age >=18 years (age >=20 years in Japan, Korea and Taiwan).
  3. 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
  4. Patients must have histologically confirmed preponderant, defined as >50%, clear cell RCC.
  5. Patients must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) treatment for RCC.
  6. Patients must not have received any previous anti angiogenic treatment.
  7. Patients must have adequate organ function.

Exclusion Criteria

  1. Histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma, lymphoma, or patients with any metastatic renal sites.
  2. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage <4 weeks of date of randomization.
  3. 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.
  4. 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.
  5. Gastrointestinal abnormalities
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Please refer to this study by its identifier: NCT01599754

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Sponsors and Collaborators
SFJ Pharmaceuticals, Inc.
  More Information

Responsible Party: SFJ Pharmaceuticals, Inc. Identifier: NCT01599754     History of Changes
Other Study ID Numbers: AP311736
Study First Received: May 11, 2012
Last Updated: May 11, 2016

Keywords provided by SFJ Pharmaceuticals, Inc.:
renal cell carcinoma
tyrosine kinase inhibitor

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017