A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma, Trial ID AGS-16C3F-15-3

Study summary

The purpose of this study was 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.

Additional Study Details

Phase

Phase 2

Product

AGS-16C3F

Product

AGS-16C3F

Axitinib

Type

Interventional

Masking

None (Open Label)

Enrollment number

133

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Study documents

Scientific Results Summary

Available Language(s): English

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Plain Language Summary

Available Language(s): English

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Protocol

Available Language(s): English

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Statistical Analysis Plan (SAP)

Available Language(s): English

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Locations

Withdrawn

Site US01025

Dallas, TX, United States, 75246

Completed

Site US01011

Charleston, SC, United States, 29425

Completed

Site US01010

Atlanta, GA, United States, 30322

Completed

Site CA02008

London, Ontario, Canada, N6A 5W9

Completed

Site US01012

Omaha, NE, United States, 68130

Completed

Site US01019

Palo Alto, CA, United States, 94305

Completed

Site US01003

Houston, TX, United States, 77030

Completed

Site CA02001

Vancouver, British Columbia, Canada, V5Z 4E6

Completed

Site US01002

Boston, MA, United States, 02215

Completed

Site US01006

Buffalo, NY, United States, 14263

Completed

Site US01001

Seattle, WA, United States, 98109

Completed

Site US01013

Detroit, MI, United States, 48202

Completed

Site US01021

Pittsburgh, PA, United States, 15232

Withdrawn

Site US01005

Las Vegas, NV, United States, 89169

Withdrawn

Site US01016

Encinitas, CA, United States, 92011

Completed

Site US01014

Temple, TX, United States, 76508

Completed

Site US01023

Baltimore, MD, United States, 21201

Withdrawn

Site US01015

Oklahoma City, OK, United States, 73104

Completed

Site US01009

Milwaukee, WI, United States, 53226

Completed

Site US01026

Tucson, AZ, United States, 85719

Completed

Site CA02005

Kelowna, British Columbia, Canada, V1Y 5L3

Completed

Site US01004

Ann Arbor, MI, United States, 48109

Completed

Site CA02004

Edmonton, Alberta, Canada, T6G 1Z2

Completed

Site CA02002

Hamilton, Ontario, Canada, L8V 5C2

Completed

Site CA02006

Calgary, Alberta, Canada, T2N 4N2

Completed

Site US01008

La Jolla, CA, United States, 92093

Completed

Site US01022

Durham, NC, United States, 27710

Completed

Site US01017

Portland, OR, United States, 97213

Withdrawn

Site US01018

Minneapolis, MN, United States, 55455

Completed

Site US01007

Los Angeles, CA, United States, 90033

Completed

Site US01020

Los Angeles, CA, United States, 90095

Trial info

Follow Trial

Age

18+ years

Condition

Kidney Cancer

Sex

Female & Male

Trial Dates

May 2016 - Aug 2019

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Additional Study Details

Inclusion Criteria

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:

1. Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L

2. Platelet count ≥ 100 x 10 9/L

3. Hemoglobin ≥ 9 g/dL (transfusions are allowed)

Renal Function as follows:

1. 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:

1. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5x ULN if known liver metastases

2. 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:

1. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or

2. documented surgically sterile

Or, if of childbearing potential,

1. Agree not to try to become pregnant during the study and for 6 months after the final study drug administration

2. 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

Exclusion Criteria

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
- Monocularity
- 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 glaucoma (topical medications allowed)
- 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.

Frequently Asked Questions

Are clinical trials only for people with advanced cancer?

While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

Will I have to stop my current treatment to participate in a clinical trial?

Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

Should I be worried about getting a placebo?

In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

Do I need a referral from my doctor to take part in a study?

Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

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A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma

Study summary

Additional Study Details

Study documents

Get more information

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Frequently Asked Questions

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