The 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.
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Locations near you
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Full eligibility criteria for NCT02639182
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Histologically confirmed diagnosis of RCC
Non-clear subjects must be ENPP3 positive, defined as IHC H-score ≥15
Has evidence of progression on or after the last regimen received:
Clear cell subject: must have received at least 2 prior systemic regimens, one of which is an anti-VEGF agent.
Non-clear cell subject: must have received at least one prior anti-VEGF regimen
Has measurable disease according to Response Criteria for Solid Tumors (RECIST v.1.1)
Has Eastern Cooperative Group (ECOG) performance status of 0 or 1
Has archive tumor tissue from primary tumor or metastatic site (excluding bone), for which the source and availability have been confirmed.
If no archive tissue is available, the subject may elect to have a biopsy performed to obtain tissue.
Has adequate organ function including:
Hematopoietic function as follows:
Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L
Platelet count ≥ 100 x 10 9/L
Hemoglobin ≥ 9 g/dL (transfusions are allowed)
Renal Function as follows:
Creatinine ≤ 1.5 x upper limit of normal (ULN), or calculated glomerular filtration rate (GFR) > 40 mL/min (Cockcroft-Gault) if creatinine > 1.5x ULN
Hepatic function, as follows:
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5x ULN if known liver metastases
Total bilirubin ≤ 1.5 x ULN
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) levels ≤1.5 x ULN. If institution does not report PT value, the international normalization ratio
(INR) must be ≤ ULN.
If subject is receiving Coumadin (warfarin), a stable international normalization ratio (INR) of 2-3 is required.
No clinical symptoms of hypothyroidism
Urine Protein to Creatinine Ratio (uPCR) < 2.0
If uPCR ≥ 2.0 then a 24-hour urine collection can be performed to qualify. If this is performed to qualify, the protein result must be < 2 g per 24 hours.
Female subject must either:
Be of non-childbearing potential:
post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
documented surgically sterile
Or, if of childbearing potential,
Agree not to try to become pregnant during the study and for 6 months after the final study drug administration
And have a negative serum pregnancy test ≤ 10 days of cycle 1, day 1 (C1D1)
And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 6 months after the final study drug administration.
Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
Female subject must not donate ova starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception* consisting of 2 forms of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 6 months after the final study drug administration
Male subject must not donate sperm starting at Screening and throughout the study period and, for 6 months after the final study drug administration Note: *Highly effective forms of birth control include:
Consistent and correct usage of established oral contraception.
Established intrauterine device (IUD) or intrauterine system (IUS).
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Has previously been treated with axitinib, AGS-16C3F, or AGS-16M8F
Has untreated brain metastasis. In the case of a solitary brain metastasis which has been resected, there must be evidence of a disease-free interval of at least 3 months post-surgery. For brain metastases treated with whole brain or stereotactic radiation therapy, brain imaging must be stable > 3 months. All subjects previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days prior to C1D1.
Has uncontrolled hypertension defined as blood pressure > 150/90 on medication(s) by 2 blood pressure readings taken at least 1 hour apart.
Has gastrointestinal abnormalities including:
inability to take oral medication;
requirement for intravenous alimentation;
prior surgical procedures affecting absorption including total gastric resection;
active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
malabsorption syndromes such as celiac disease, cystic fibrosis, inflammatory bowel disease, systemic sclerosis, and carcinoid syndrome
Has ocular conditions such as:
Active infection or corneal ulcer
Visual acuity of 20/70 or worse in both eyes
History of corneal transplantation
Contact lens dependent (if using contact lens, must be able to switch to glasses during the entire study duration)
Uncontrolled or active ocular problems (e.g., retinopathy, macular edema, active uveitis, wet macular degeneration) requiring surgery, laser treatment, or intravitreal injections
Papilledema or other active optic nerve disorder
Has used any investigational drug (including marketed drugs not approved for this indication) ≤ 14 days of C1D1. No time limit applies to the use of marketed drugs approved for this indication provided that the subject has progressed on the treatment and all toxicities attributable to the drug have resolved, returned to baseline or stabilized.
Has known sensitivity to any of the ingredients of:
investigational product AGS-16C3F and/or,
Inlyta® (axitinib) and/or,
1% prednisolone acetate ophthalmic suspension and any other corticosteroids.
Is currently using (i.e., within 14-days prior to first dose) drugs that are known strong CYP3A4/5 inhibitors / inducers.
Thromboembolic event (e.g., deep vein thrombosis [DVT] and pulmonary embolism [PE]) ≤ 4 weeks of C1D1.
Subjects who had a thromboembolic event ≤ 4 weeks of C1D1 must be receiving adequate anticoagulation treatment for at least 2 weeks before C1D1 and must continue as clinically indicated post first dose
Has history bleeding disorders (e.g., pulmonary hemorrhage, significant hemoptysis, menometrorrhagia not responding to hormonal treatment) ≤ 2 months before C1D1
Has active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 6 months of randomization, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, congestive heart failure, or arrhythmias not controlled by medication.
Had major surgery ≤ 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) ≤ 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.
All locations for NCT02639182
United States (20)
Tucson, Arizona, United States, 85719
La Jolla, California, United States, 92093
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90095
Palo Alto, California, United States, 94305
Atlanta, Georgia, United States, 30322
Baltimore, Maryland, United States, 21201
Boston, Massachusetts, United States, 02215
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48202
Omaha, Nebraska, United States, 68130
Buffalo, New York, United States, 14263
Durham, North Carolina, United States, 27710
Portland, Oregon, United States, 97213
Pittsburgh, Pennsylvania, United States, 15232
Charleston, South Carolina, United States, 29425
Houston, Texas, United States, 77030
Temple, Texas, United States, 76508
Seattle, Washington, United States, 98109
Milwaukee, Wisconsin, United States, 53226
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Kelowna, British Columbia, Canada, V1Y 5L3
Vancouver, British Columbia, Canada, V5Z 4E6
Hamilton, Ontario, Canada, L8V 5C2
London, Ontario, Canada, N6A 5W9
View full eligibility
Tris trial is registered with FDA with number: NCT02639182. The sponsor of the trial is Astellas Pharma Global Development, Inc. and it is looking for 134 volunteers for the current phase.
Official trial title: A Multi-Center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
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