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

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ClinicalTrials.gov Identifier: NCT01599754
Recruitment Status : Active, not recruiting
First Posted : May 16, 2012
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Clear Cell Renal Carcinoma Drug: Axitinib Drug: Placebo Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : April 2012
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : May 2019


Arms and Interventions

Arm Intervention/treatment
Experimental: Axitinib Drug: Axitinib
Axitinib 5 mg twice daily
Other Name: Inlyta
Placebo Comparator: Placebo Drug: Placebo
Placebo twice daily


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.


Eligibility Criteria

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

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599754


  Show 106 Study Locations
Sponsors and Collaborators
SFJ Pharma Ltd. II
Pfizer
SFJ Pharmaceuticals, Inc.
More Information

Responsible Party: SFJ Pharma Ltd. II
ClinicalTrials.gov Identifier: NCT01599754     History of Changes
Other Study ID Numbers: AP311736
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Keywords provided by SFJ Pharmaceuticals, Inc. ( SFJ Pharma Ltd. II ):
renal cell carcinoma
axitinib
tyrosine kinase inhibitor

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Axitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action