A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
A Multi-Center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
1 other identifier
interventional
133
2 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2016
Typical duration for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2015
CompletedFirst Posted
Study publicly available on registry
December 24, 2015
CompletedStudy Start
First participant enrolled
May 3, 2016
CompletedResults Posted
Study results publicly available
September 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2020
CompletedNovember 18, 2024
October 1, 2024
4.4 years
December 21, 2015
August 20, 2020
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigator Radiologic Review
PFS was defined as the time from the date of randomization to the earliest of documented disease progression as defined by RECIST v.1.1 or death from any cause. PFS was analysed using Kaplan-Meier estimates. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters (longest for non-nodal lesions, short axis for nodal lesions) of the target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of 1 or more new lesions is also considered progression. Participants were censored if there were 2 or more than 2 consecutive missing assesments immediately prior to death or progression; or no death and no postebaseline assesments; or if ininitiated non protocol anticancer treatment prior to death or prior to documentation of disease progression; or alive and not progressed.
From date of randomization to the earliest of either documented disease progression or death from any cause (up to 53 months)
Secondary Outcomes (21)
PFS Per RECIST v1.1 as Assessed by Blinded Central Radiology Assessment
From date of randomization to the earliest of either documented disease progression or death from any cause (up to 40 months)
Objective Response Rate (ORR) Based on the Investigator's Radiographic Assessment
From date of randomization until data cutoff date of 21 August 2019 (up to 40 months)
Duration of Response (DOR) Based on the Investigator's Radiographic Assessment
From date of first objective response until data cutoff date of 21 August 2019 (up to 40 months)
Overall Survival (OS)
Date of randomization until the date of death from any cause (up to 53 months)
Disease Control Rate (DCR) Based on the Investigator's Radiographic Assessment
Date of randomization until data cutoff date of 21 August 2019 (up to 40 months)
- +16 more secondary outcomes
Study Arms (2)
AGS-16C3F
EXPERIMENTALParticipants received 1.8 milligram per kilogram (mg/kg) of AGS-16C3F once every three weeks by single intravenous (IV) infusion.
Axitinib
ACTIVE COMPARATORParticipants received 2 to 10 milligram (mg) of axitinib twice daily by oral administration as defined in the product label and per local institutional guidelines.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- +25 more criteria
You may not qualify if:
- 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)
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Site US01026
Tucson, Arizona, 85719, United States
Site US01008
La Jolla, California, 92093, United States
Site US01007
Los Angeles, California, 90033, United States
Site US01020
Los Angeles, California, 90095, United States
Site US01019
Palo Alto, California, 94305, United States
Site US01010
Atlanta, Georgia, 30322, United States
Site US01023
Baltimore, Maryland, 21201, United States
Site US01002
Boston, Massachusetts, 02215, United States
Site US01004
Ann Arbor, Michigan, 48109, United States
Site US01013
Detroit, Michigan, 48202, United States
Site US01012
Omaha, Nebraska, 68130, United States
Site US01006
Buffalo, New York, 14263, United States
Site US01022
Durham, North Carolina, 27710, United States
Site US01017
Portland, Oregon, 97213, United States
Site US01021
Pittsburgh, Pennsylvania, 15232, United States
Site US01011
Charleston, South Carolina, 29425, United States
Site US01003
Houston, Texas, 77030, United States
Site US01014
Temple, Texas, 76508, United States
Site US01001
Seattle, Washington, 98109, United States
Site US01009
Milwaukee, Wisconsin, 53226, United States
Site CA02006
Calgary, Alberta, T2N 4N2, Canada
Site CA02004
Edmonton, Alberta, T6G 1Z2, Canada
Site CA02005
Kelowna, British Columbia, V1Y 5L3, Canada
Site CA02001
Vancouver, British Columbia, V5Z 4E6, Canada
Site CA02002
Hamilton, Ontario, L8V 5C2, Canada
Site CA02008
London, Ontario, N6A 5W9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Associate Medical Director
Astellas Pharma Global Development, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2015
First Posted
December 24, 2015
Study Start
May 3, 2016
Primary Completion
October 2, 2020
Study Completion
October 2, 2020
Last Updated
November 18, 2024
Results First Posted
September 23, 2020
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.