A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
|ClinicalTrials.gov Identifier: NCT02639182|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2015
Last Update Posted : June 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma||Drug: AGS-16C3F Drug: Axitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma|
|Actual Study Start Date :||May 24, 2016|
|Actual Primary Completion Date :||August 21, 2019|
|Estimated Study Completion Date :||September 2020|
AGS-16C3F will be administered as a single 60-minute intravenous (IV) infusion once every 3 weeks.
Intravenous (IV) infusion
Active Comparator: Axitinib
Axitinib will be administered twice daily continuously, by mouth.
Other Name: Inlyta®
- Progression free survival (PFS) [ Time Frame: 24 months ]Defined as the time from the date of randomization to the earliest of documented disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or death from any cause.
- PFS calculated based on blinded central radiology assessment per RECIST v.1.1 [ Time Frame: 24 months ]
- Objective response rate (ORR) based on the investigator's radiographic assessment [ Time Frame: 24 months ]ORR is defined as the proportion of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR)
- Duration of response (DOR) based on the investigator's radiographic assessment [ Time Frame: 24 months ]DOR is defined as the time from the date of the first response of CR/PR (whichever is first recorded) to the first date of documented progressive disease or death due to any cause.
- Overall survival (OS) [ Time Frame: 24 months ]OS is defined as the number of months from the date of randomization until the date of death from any cause.
- Disease control rate (DCR) assessed by the investigator's radiographic assessment [ Time Frame: 24 months ]DCR is defined as the proportion of subjets who have a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) with a minimum duration of 6 months.
- Safety profile assessed by Incidence of adverse events (AEs), laboratory tests, vital signs and electrocardiograms (ECG) [ Time Frame: 24 months ]Laboratory tests include hematology and chemistry. Vital signs include blood pressure, heart rate, and respiratory rate.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639182
|Study Director:||Associate Medical Director||Astellas Pharma Global Development, Inc.|