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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Clear Cell Renal Carcinoma

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Trial Information

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


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.


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) and Fuhrman grade:

- pT2, pN0 or pNx, M0, Fuhrman grade 3-4 (partial Fuhrman grade 3-4 is also
acceptable) and ECOG PS 0-1

- pT3, pN0 or pNx, M0, any Fuhrman grade and ECOG PS 0-1

- pT3a; Tumor > 4 cm in greatest dimension is eligible.

- pT3b or pT3c; any size of tumor is eligible.

- pT4, pN0 or pNx, M0, any Fuhrman grade and ECOG PS 0-1

- Any pT, pN1, M0, any Fuhrman grade 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

Type of Study:

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

Outcome Measure:

Disease Free Survival (DFS)

Outcome Description:

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.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

AP311736

NCT ID:

NCT01599754

Start Date:

April 2012

Completion Date:

May 2019

Related Keywords:

  • Clear Cell Renal Carcinoma
  • renal cell carcinoma
  • axitinib
  • tyrosine kinase inhibitor
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

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