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Protocol No.1638GCCPrincipal InvestigatorHussain, Arif
PhasePhase II (Cancer Control)
Age GroupAdult
TitleA Multi-Center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
DescriptionThe purpose of this study is to evaluate the progression free survival (PFS), based on investigator radiologic review, of AGS-16C3F compared to axitinib in subjects with metastatic renal cell carcinoma.
Treatment- Experimental: AGS-16C3F AGS-16C3F will be administered as a single 60-minute intravenous (IV) infusion once every 3 weeks. Intervention: Drug: AGS-16C3F - Active Comparator: Axitinib Axitinib will be administered twice daily continuously, by mouth. Intervention: Drug: Axitinib
Key EligibilityFor more detailed information visit clinicaltrials.gov and search: NCT02639182
Inclusion Criteria:
-Is at least 18 years of age
-Histologically confirmed diagnosis of metastatic RCC
-Has evidence of progression on or after the last regimen received
-Has measurable disease according to Response Criteria for Solid Tumors
-Has Eastern Cooperative Group (ECOG) performance status of 0 or 1
-Has accessible archive tumor tissue from primary tumor or metastatic site, from which at least 5 tumor tissue sections (4 microns) can be provided for the study.
-Has adequate organ function
-Renal Function as described on clinicaltrials.gov
-Hepatic function as described on clinicaltrials.gov
-No clinical symptoms of hypothyroidism
-Urine Protein to Creatinine Ratio (uPCR) < 2.0
-Female subject must either: Be of non-childbearing potential or, if of childbearing potential, agree not to try to become pregnant during the study and for 28 days after the final study drug administration and have a negative serum pregnancy test. And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control.
-Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
-Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
-Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception.
-Male subject must not donate sperm starting at Screening and throughout the study period and, for 90 days after the final study drug administration.

Exclusion Criteria:
-Has previously been treated with axitinib, AGS-16C3F, or AGS-16M8F
-Has untreated brain metastasis.
-Has uncontrolled hypertension.
-Has gastrointestinal abnormalities listed on clinicaltrials.gov
-Has ocular conditions listed on clinicaltrials.gov
-Has used any investigational drug (including marketed drugs not approved for this indication) within 2 weeks prior to date of Screening.
-Is currently using (i.e., within 14-days prior to first dose) drugs that are known strong CYP3A4/ 5 inhibitors / inducers.
-Has history of thromboembolic events.
-Has history bleeding disorders.
-Has active angina or Class III or IV Congestive Heart Failure or clinically significant cardiac disease within 6 months of randomization.
-Had major surgery within 4 weeks of C1D1.
-Is pregnant (confirmed by positive serum pregnancy test) or lactating.
-Has active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 10 days of C1D1
-Is unwilling or unable to comply with study requirements
-Has any medical or psychiatric disorder that compromises the ability of the subject to give written informed consent, and/or comply with the study procedures.
Applicable Disease SitesKidney
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02639182
ContactGreenebaum Cancer Center Shelle Besche, RN, BSN, OCN, CCRP Phone:410-328-8610
Pager:410-328-2337 #11582
Email:mbesche@umm.edu
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