Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients
NCT01599754
ABOUT THIS STUDY
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Adult Trials: 18+ Years
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.
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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| 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 |
| ||
| Study Arms ICMJE |
| ||
| 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 | 724 | ||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria
| ||
| Sex/Gender ICMJE |
| ||
| 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 |
| ||
| 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 | |||