Trial · NCT01772004
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Dose Escalation: Baseline up to Week 3 | DLT analysis set included all participants with data used for implementing the dose-escalation schedule. These participants should have received all study drug administrations in the DLT evaluation period, or should have stopped treatment because of DLTs in the DLT evaluation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Ovarian Cancer Efficacy Expansion: Baseline up to Day 620 | Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931 | Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871 | Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | HNSCC Efficacy Expansion: Baseline up to Day 1072 | Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity | Up to Day 2511 | Safety analysis set (SAF) included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity | Baseline up to Day 2511 | SAF included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under Serum Concentration-Time Curve From the Time of Dosing to the Time of the Last Observation (AUC0-t) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. | Hours*micrograms per milliliter | MEAN |
| SECONDARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here Overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Hours*micrograms per milliliter | MEAN |
| SECONDARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Maximum Observed Serum Concentration (Cmax) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. | Micrograms per milliliter (mcg/mL) | MEAN |
| SECONDARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Time to Reach Maximum Observed Serum Concentration (Tmax) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. | Hours | MEDIAN |
| SECONDARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Apparent Terminal Half-Life (t1/2) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here Overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Hours | MEDIAN |
| SECONDARY | Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab | At Day 1, 15, 29, 43, 85, 127 and 169 | Pharmacokinetic analysis set was used. Here Overall number of participants analyzed signifies those who were evaluable for this outcome measure and Number analyzed signifies those who were evaluable at specified time points. Data was reported for those arms for which end of infusion sample were collected as per planned analysis. | Microgram per milliliter | MEAN |
| SECONDARY | Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab | At Day 15, 29, 43, 57, 71, 85, 99, 127 and 169 | Pharmacokinetic analysis set was used. Here Overall number of participants analyzed signifies those who were evaluable for this outcome measure and Number analyzed signifies those who were evaluable at specified time points. Data for primary expansion cohort: GC/GEJC Progressed and primary expansion cohort: GC/GEJC Non progressed arms was reported as a single arm primary expansion cohort: GC/GEJC Progressed/Non progressed for this outcome measure as per planned analysis. | Microgram per milliliter | MEAN |
| SECONDARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC) | Dose Escalation: Baseline up to Day 1023 | Safety analysis set included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Expansion Cohort: Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC) | Dose Expansion: Baseline up to Day 2023 | Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Dose Escalation: Baseline up to Day 2511 | Safety analysis set included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Expansion Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Dose Expansion: Baseline up to Day 2023 | Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee | Secondary Urothelial Carcinoma Dose Expansion: Baseline up to Day 931 | FAS included all participants who have received at least 1 dose of study treatment. This outcome measure was planned to be analyzed in Secondary Urothelial Carcinoma Cohort only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Expansion Cohort: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Dose Expansion: Baseline up to Day 2023 | FAS included all participants who have received at least 1 dose of study treatment. Here Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Months | MEDIAN |
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.
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