Trial · NCT02108652
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population included Intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 2 ITT population included all participants from Cohort 2 who received any amount of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. | months | MEDIAN |
| SECONDARY | DOR as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. | months | MEDIAN |
| SECONDARY | DOR as Assessed by the Investigator According to Modified RECIST | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | months | MEDIAN |
| SECONDARY | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | percentage of participants | NUMBER |
| SECONDARY | PFS as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | months | MEDIAN |
| SECONDARY | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | percentage of participants | NUMBER |
| SECONDARY | PFS as Assessed by the Investigator According to Modified RECIST | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | months | MEDIAN |
| SECONDARY | Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 objective response-evaluable population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died | Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 ITT population | months | MEDIAN |
| SECONDARY | Percentage of Participants Alive at 1-year | 1-year | Cohort 2 ITT Population | percentage of participants | NUMBER |
| SECONDARY | Maximum Serum Concentration (Cmax) of Atezolizumab | Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days) | Cohort 2 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome. | microgram(s)/milliliter (mcg/mL) | MEAN |
| SECONDARY | Minimum Serum Concentration (Cmin) of Atezolizumab | Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days) | Cohort 2 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. n = participants who were evaluable at specified timepoint. | mcg/mL | MEAN |
| SECONDARY | Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab | Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | Cohort 2 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT02108652/outcomes