Trial record 1 of 1 for:
ADJUVANT AXITINIB TREATMENT OF RENAL CANCER: A RANDOMIZED
Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients (ATLAS)
Verified March 2016 by SFJ Pharmaceuticals, Inc.
Information provided by (Responsible Party):
SFJ Pharmaceuticals, Inc.
First received: May 11, 2012
Last updated: March 2, 2016
Last verified: March 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.
Clear Cell Renal Carcinoma
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
||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
Primary Outcome Measures:
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2017 (Final data collection date for primary outcome measure)
Axitinib 5 mg twice daily
Other Name: Inlyta
Placebo Comparator: Placebo
Placebo twice daily
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
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
SFJ Pharmaceuticals, Inc.
||SFJ Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 11, 2012
||March 2, 2016
||Japan: Ministry of Health, Labor and Welfare
Keywords provided by SFJ Pharmaceuticals, Inc.:
renal cell carcinoma
tyrosine kinase inhibitor
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 27, 2016
Carcinoma, Renal Cell
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors