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Trial record 1 of 1 for:    ADJUVANT AXITINIB TREATMENT OF RENAL CANCER: A RANDOMIZED
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Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients (ATLAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by SFJ Pharmaceuticals, Inc.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
SFJ Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01599754
First received: May 11, 2012
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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: 592
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.

The 592 patients will be randomized in a 1:1 ratio between axitinib vs placebo.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599754

Contacts
Contact: Rolf Linke, MD +1-650-954-0106 rolf.linke@sfj-pharma.com
Contact: Clinton White, PHD 1-925-963-8696 clinton.white@sfj-pharma.com

  Show 74 Study Locations
Sponsors and Collaborators
SFJ Pharmaceuticals, Inc.
Pfizer
  More Information

No publications provided

Responsible Party: SFJ Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01599754     History of Changes
Other Study ID Numbers: AP311736
Study First Received: May 11, 2012
Last Updated: April 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on November 25, 2014