Status:
TERMINATED
Akt Inhibitor MK2206 or Everolimus in Treating Patients With Refractory Kidney Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Metastatic Kidney Carcinoma
Recurrent Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies the side effects and how well Akt inhibitor MK2206 or everolimus works in treating patients with kidney cancer that does not respond to treatment. Akt inhibitor ...
Detailed Description
PRIMARY OBJECTIVES: I. To assess progression free survival (PFS) of vascular endothelial growth factor (VEGF) therapy refractory renal cell carcinoma (RCC) patients who receive either MK-2206 (Akt in...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed metastatic or unresectable RCC; all histologies are permitted; patient should have undergone nephrectomy
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan
- Patients must have received, and progressed on an anti-VEGF therapy, including bevacizumab, sorafenib, sunitinib or pazopanib
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
- Serum creatinine =\< 1.5 x upper limit of normal (ULN)
- International normalized ratio (INR) and partial thromboplastin time (PTT) =\< 1.5 x ULN; therapeutic anticoagulation with warfarin is allowed if target INR =\< 3 on a stable dose of warfarin or on a stable dose of low molecular weight (LMW) heparin for \> 2 weeks at time of randomization
- Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 8 weeks after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- Serum pregnancy test in female patients of childbearing potential must be negative within 24 hours of enrolling on this study
Exclusion
- Patients who received oral tyrosine-kinase inhibitors (TKIs) (sorafenib, sunitinib, or pazopanib) within 2 weeks prior to entering the study, radiotherapy, immunotherapy or chemotherapy within 4 weeks prior to entering the study, bevacizumab within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (recovered to =\< grade 1)
- Patients may not be receiving any other investigational agents; patients may not have received an mammalian target of rapamycin (mTOR) inhibitor
- Patients with known brain metastases should be excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in the study
- Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP4503A4) are ineligible
- Patient should have a hemoglobin A1C value of \< 8%; preclinical studies demonstrated the potential of MK-2206 for induction of hyperglycemia in all preclinical species tested; studies also demonstrate a risk of hyperglycemia, hyperlipidemia and hypertriglyceridemia associated with everolimus therapy; patients with diabetes or in risk for hyperglycemia, hyperlipidemia and/or hypertriglyceridemia should not be excluded from trials with MK-2206 or everolimus, but the patient should be well controlled on oral agents (recent \[i.e. within 3 months\] hemoglobin \[Hb\]A1C =\< 7.0) before the patient enters the trial
- Baseline corrected Fridericia QT interval (QTcF) \> 450 msec (male) or QTcF \> 470 msec (female) will exclude patients from entry on study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK-2206 or everolimus
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
- Individuals who are diagnosed with an intercurrent cancer are excluded, with the exception of non-melanoma skin cancers, and other cancers where curative treatment was completed at least two years ago
Key Trial Info
Start Date :
January 27 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2018
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01239342
Start Date
January 27 2011
End Date
September 19 2018
Last Update
October 10 2019
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817