Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients

NCT01599754

Last updated date
Study Location
La Jolla, California, 92093, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Clear Cell Renal Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Clear Cell Renal CarcinomaAdjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients
NCT01599754
  1. La Jolla, California
  2. Los Angeles, California
  3. Palo Alto, California
  4. Pleasant Hill, California
  5. Denver, Colorado
  6. Washington, District of Columbia
  7. Ocala, Florida
  8. Atlanta, Georgia
  9. Annapolis, Maryland
  10. Baltimore, Maryland
  11. Saint Paul, Minnesota
  12. Omaha, Nebraska
  13. Hackensack, New Jersey
  14. Albany, New York
  15. New York, New York
  16. Portland, Oregon
  17. Charleston, South Carolina
  18. Chattanooga, Tennessee
  19. Austin, Texas
  20. Bedford, Texas
  21. Dallas, Texas
  22. Houston, Texas
  23. San Antonio, Texas
  24. San Antonio, Texas
  25. Norfolk, Virginia
  26. Seattle, Washington
  27. Beijing,
  28. Changchun,
  29. Chongqing,
  30. Dalian,
  31. Guangzhou,
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  33. Jinan,
  34. Nanchang,
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  61. Mangalore,
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  63. Mumbai,
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  65. New Delhi,
  66. Pune,
  67. Surat,
  68. Vishakhapatnam,
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  71. Aomori,
  72. Chiba,
  73. Fukuoka,
  74. Gifu,
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  92. Gyeonggi,
  93. Jeonnam,
  94. Seoul,
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  96. Leganes,
  97. Llobregat,
  98. Madrid,
  99. Oviedo,
  100. San Sebastian,
  101. Sevilla,
  102. Valencia,
  103. Zaragoza,
  104. Taichung,
  105. Taipei,
  106. Taoyuan,
ALL GENDERS
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years
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Advanced Information
Descriptive Information
Brief Title  ICMJE Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Clear Cell Renal Carcinoma
Intervention  ICMJE
  • Drug: Axitinib
    Axitinib 5 mg twice daily
    Other Name: Inlyta
  • Drug: Placebo
    Placebo twice daily
Study Arms  ICMJE
  • Experimental: Axitinib
    Intervention: Drug: Axitinib
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Gross-Goupil M, Kwon TG, Eto M, Ye D, Miyake H, Seo SI, Byun SS, Lee JL, Master V, Jin J, DeBenedetto R, Linke R, Casey M, Rosbrook B, Lechuga M, Valota O, Grande E, Quinn DI. Axitinib versus placebo as an adjuvant treatment of renal cell carcinoma: results from the phase III, randomized ATLAS trial. Ann Oncol. 2018 Dec 1;29(12):2371-2378. doi: 10.1093/annonc/mdy454.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 22, 2019)
724
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2012)
592
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date October 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   France,   Hong Kong,   India,   Japan,   Korea, Republic of,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01599754
Other Study ID Numbers  ICMJE AP311736
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SFJ Pharmaceuticals, Inc. ( SFJ Pharma Ltd. II )
Study Sponsor  ICMJE SFJ Pharma Ltd. II
Collaborators  ICMJE
  • Pfizer
  • SFJ Pharmaceuticals, Inc.
Investigators  ICMJE Not Provided
PRS Account SFJ Pharmaceuticals, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP