Trial · NCT03504397
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days) | FAS | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the date of randomization until 62 months and 18 days | FAS | Months | MEDIAN |
| SECONDARY | Time to Confirmed Deterioration (TTCD) Using Physical Functioning (PF) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) | From the date of randomization until 62 months and 18 days | FAS | Months | MEDIAN |
| SECONDARY | Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25 | From the date of randomization until 62 months and 18 days | FAS | Months | MEDIAN |
| SECONDARY | Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30 | From the date of randomization until 62 months and 18 days | FAS | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From the date of randomization until 62 months and 18 days | FAS | Percentage of participants | NUMBER |
| SECONDARY | Duration Of Response (DOR) | From date of first response (CR/PR) until 62 months and 18 day | FAS - All Objective Responders | Months | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose until 62 months and 18 days | Safety analysis set (SAF) included all participants who received at least 1 dose of any study drug (zolbetuximab/placebo and mFOLFOX6). | Participants | NUMBER |
| SECONDARY | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline, cycle (C) 1 day (D) 22, D1 and D22 of C2 through C39 | FAS with available data was analyzed. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire | Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up | FAS with available data was analyzed. | units on Scale | MEAN |
| SECONDARY | Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire | Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up | FAS with available data was analyzed. | unit on a scale | MEAN |
| SECONDARY | Change From Baseline in HRQoL Measured by Global Pain (GP) | Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up | FAS with available data was analyzed. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire | Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up | FAS with available data was analyzed. | units on a scale | MEAN |
| SECONDARY | Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough) | Predose on C1D22, C3D1, C5D1, C7D1, C9D1 | PKAS consisted of the subset of the SAF for which at least 1 zolbetuximab concentration measurement was available. Participants with available data at each timepoint were analyzed. | micrograms/mililiter (ug/mL) | MEAN |
| SECONDARY | Number of Participants With Anti-drug Antibodies (ADA) | Predose on C1D1, C1D22, C3D1, C5D1, C7D1, C9D1, 30-day follow up, 90-day follow up | Participants who were randomized to zolbetuximab + mFOLFOX6 Arm with at least One Valid Result for ADA. | 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.
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