Overview

This trial is active, not recruiting.

Condition clear cell renal carcinoma
Treatments axitinib, placebo
Phase phase 3
Targets VEGF, PDGF
Sponsor SFJ Pharmaceuticals, Inc.
Collaborator Pfizer
Start date April 2012
End date June 2017
Trial size 700 participants
Trial identifier NCT01599754, AP311736

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
axitinib Inlyta
Axitinib 5 mg twice daily
(Placebo Comparator)
placebo
Placebo twice daily

Primary Outcomes

Measure
Disease Free Survival (DFS)
time frame: 5 years

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: 5 years
Safety
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by SFJ Pharmaceuticals, Inc..
Location data was received from the National Cancer Institute and was last updated in May 2016.