Trial · NCT02639182
A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
NCT02639182, Phase 2, Completed, Astellas Pharma Global Development, Inc.; results first posted 2020-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma. Trials, record NCT02639182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02639182
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
- NCT number
- NCT02639182
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 133 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Metastatic Renal Cell Carcinoma
- Interventions
- AGS-16C3F, Axitinib
- First posted
- 2015-12-24
- Last updated
- 2024-11-18
- Results first posted
- 2020-09-23
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigator Radiologic Review | From date of randomization to the earliest of either documented disease progression or death from any cause (up to 53 months) | 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. |
| Secondary | 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) | 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. 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 5mm. 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 assessments immediately prior to death or progression; or no death and no postebaseline assessments; or if initiated non protocol anticancer treatment prior to death or prior to documentation of disease progression; or alive and not progressed. |
| Secondary | 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) | ORR was defined as the percentage of participants who had a best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) with reduction in short axis to \<10mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. |
| Secondary | 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) | DOR was defined as the time from the date of the first response of CR or PR (whichever was first recorded) to the first date of documented PD or death due to any cause. DOR was analysed using Kaplan-Meier estimates. CR and PR were defined in outcome measure 3 and PD was defined in outcome measures 1 and 2. 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. |
| Secondary | Overall Survival (OS) | Date of randomization until the date of death from any cause (up to 53 months) | OS was defined as the time from the date of randomization until the date of death from any cause. OS was analysed using Kaplan-Meier estimates. Participants were censored if there was no death and no postbaseline contact or no death and at least one postbaseline follow-up. |
| Secondary | 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) | DCR was defined as the percentage of patients who had a best overall response of CR, PR or at least 6 months with stable disease (SD). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) with reduction in short axis to \<10mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. |
| Secondary | Number of Participants With Adverse Events | From first dose up to 53 months | AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, ECG data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator. AE was considered "serious" if it results in death or is life threatening results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions or results in congenital anomaly, or birth defect requires inpatient hospitalization or leads to prolongation of hospitalization or other medically important events. |
| Secondary | Maximum Observed Serum Concentration (Cmax) of Antibody Drug Conjugate (ADC) | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | Cmax of ADC was reported. |
| Secondary | Mean Predose Serum Concentration (Ctrough) of ADC | Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days) | Ctrough of ADC was reported. |
| Secondary | Time to Maximum Observed Serum Concentration (Tmax) of ADC | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | Tmax of ADC was reported. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigator Radiologic Review | From date of randomization to the earliest of either documented disease progression or death from any cause (up to 53 months) | FAS Population | Months | MEDIAN |
| SECONDARY | 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) | FAS Population | Months | MEDIAN |
| SECONDARY | 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) | FAS Population | Percentage of Participants | NUMBER |
| SECONDARY | 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) | FAS Population | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Date of randomization until the date of death from any cause (up to 53 months) | FAS Population | Months | MEDIAN |
| SECONDARY | 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) | FAS Population | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events | From first dose up to 53 months | Safety Population: All randomized participants who received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) of Antibody Drug Conjugate (ADC) | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | Pharmacokinetic Population (PKAS): (included all participants who were randomized to receive AGS-16C3F and had sufficient serum concentration data to facilitate derivation of at least 1 pharmacokinetic parameter, and for whom the time of dosing on the day of sampling was known) with available data at specified time point. | Microgram per Milliliter (μg/mL) | MEAN |
| SECONDARY | Mean Predose Serum Concentration (Ctrough) of ADC | Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days) | PKAS Population. Here, number of participants analyzed signifies participants who had quantifiable data. | Nanogram per Milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Maximum Observed Serum Concentration (Tmax) of ADC | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | PKAS Population with available data at specified time point. | Days | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigator Radiologic Review | AGS-16C3F | 2.9 | 95% Confidence Interval 2.0 to 4.0 | Months | |
| Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigator Radiologic Review | Axitinib | 5.7 | 95% Confidence Interval 5.3 to 9.1 | Months | |
| PFS Per RECIST v1.1 as Assessed by Blinded Central Radiology Assessment | AGS-16C3F | 3.5 | 95% Confidence Interval 2.1 to 3.8 | Months | |
| PFS Per RECIST v1.1 as Assessed by Blinded Central Radiology Assessment | Axitinib | 4.5 | 95% Confidence Interval 3.5 to 7.6 | Months | |
| Objective Response Rate (ORR) Based on the Investigator's Radiographic Assessment | AGS-16C3F | 7.5 | 95% Confidence Interval 2.5 to 16.6 | Percentage of Participants | |
| Objective Response Rate (ORR) Based on the Investigator's Radiographic Assessment | Axitinib | 18.2 | 95% Confidence Interval 9.8 to 29.6 | Percentage of Participants | |
| Duration of Response (DOR) Based on the Investigator's Radiographic Assessment | AGS-16C3F | 6.8 | 95% Confidence Interval 3.8 to 18.4 | Months | |
| Duration of Response (DOR) Based on the Investigator's Radiographic Assessment | Axitinib | 6.7 | 95% Confidence Interval 1.8 to 9.2 | Months | |
| Overall Survival (OS) | AGS-16C3F | 13.1 | 95% Confidence Interval 10.1 to 23.0 | Months | |
| Overall Survival (OS) | Axitinib | 15.5 | 95% Confidence Interval 12.7 to 21.6 | Months |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AGS-16C3F | 67 | |
| Overall Study | STARTED | Axitinib | 66 | |
| Overall Study | Treated | AGS-16C3F | 66 | |
| Overall Study | Treated | Axitinib | 65 | |
| Overall Study | COMPLETED | AGS-16C3F | 0 | |
| Overall Study | COMPLETED | Axitinib | 0 | |
| Overall Study | NOT COMPLETED | AGS-16C3F | 67 | |
| Overall Study | NOT COMPLETED | Axitinib | 66 |
Source ClinicalTrials.gov
Adverse events342
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | AGS-16C3F | 15 | 66 | 35 |
| other | Anaemia | Blood and lymphatic system disorders | Axitinib | 4 | 65 | 7 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | AGS-16C3F | 5 | 66 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Axitinib | 0 | 65 | 0 |
| other | Hypothyroidism | Endocrine disorders | AGS-16C3F | 1 | 66 | 1 |
| other | Hypothyroidism | Endocrine disorders | Axitinib | 7 | 65 | 8 |
| other | Diplopia | Eye disorders | AGS-16C3F | 4 | 66 | 4 |
| other | Diplopia | Eye disorders | Axitinib | 0 | 65 | 0 |
| other | Dry eye | Eye disorders | AGS-16C3F | 14 | 66 | 18 |
| other | Dry eye | Eye disorders | Axitinib | 6 | 65 | 6 |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AGS-16C3F | 36 | 67 |
| Total, all-cause mortality | Axitinib | 44 | 66 |
| Total, other adverse events | AGS-16C3F | 65 | 66 |
| Total, other adverse events | Axitinib | 64 | 65 |
| Total, serious adverse events | AGS-16C3F | 26 | 66 |
| Total, serious adverse events | Axitinib | 31 | 65 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AGS-16C3F vs Axitinib: Number of Participants With Adverse Events | Trial comparisons |
| AGS-16C3F vs Axitinib: deaths from any cause | Trial comparisons |
| AGS-16C3F vs Axitinib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02639182
GET https://conductscience.org/api/trials/v1/NCT02639182/registered?page=2