Trial · NCT03468426
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 - Number of Patients With Dose Limiting Toxicity (DLT) Within the First Cycle of Treatment | The first treatment cycle, up to 21 days. | Number of patients with dose limiting toxicity (DLT) within the first cycle of treatment. |
| Primary | Part 2 - Objective Response (OR) | Up to 778 days. | Objective Response (OR) defined as best overall response (Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)) of complete response (CR) or partial response (PR) from first treatment infusion until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent. In case of recurrent glioblastoma (GBM), assessment will be based on RANO (Response Assessment in Neuro-Oncology) criteria. |
| Secondary | Part 1 - Adverse Events (AEs) | Up to 1263 days. | The number of patients with any adverse events (AEs). |
| Secondary | Part 1 - Drug Related AEs | Up to 1263 days. | The number of patients with any drug related adverse events (AEs). |
| Secondary | Part 1 - Drug Related AEs Leading to Dose Reduction or Discontinuation | Up to 1263 days. | The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation. |
| Secondary | Part 2 - Adverse Events (AEs) | Up to 778 days. | The number of patients with any adverse events (AEs). |
| Secondary | Part 2 - Drug Related AEs | Up to 778 days. | The number of patients with any drug related adverse events (AEs). |
| Secondary | Part 2 - Drug Related AEs Leading to Dose Reduction or Discontinuation | Up to 778 days. | The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation. |
| Secondary | Part 2 - Disease Control (DC) | Up to 778 days. | Disease control (DC), defined as best overall response of CR, PR, or stable disease (SD) (Response Assessment in Neuro-Oncology (RANO for GBM \& RECIST1.1 for all other cohorts). |
| Secondary | Part 2 - Duration of Objective Response (DoR) | Up to 84.4 weeks. | Duration of objective response (DoR), defined as the time from first documented CR or PR (RANO for GBM \& RECIST1.1 for all other cohorts) until the earliest of disease progression or death among patients with OR. |
| Secondary | Part 2 - Progression-free Survival (PFS) | Up to 778 days. | Progression-free survival (PFS) (RANO for GBM \& RECIST1.1 for all other cohorts), defined as the time from first treatment infusion until disease progression or death from any cause, whichever occurs earlier. Tumour shrinkage (in millimeters), defined as the difference between the minimum post-baseline sum of diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) and the baseline sum of diameters of the same set of target lesions in case of RECIST. In GBM, using RANO criteria, tumor shrinkage will be calculated based on the difference between the post-baseline and baseline measurements of the sum of product of the largest bi-dimensional measurements for all target lesions. |
| Secondary | Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | Part 1 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the first infusion cycle. |
| Secondary | Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the Fourth Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle. | Part 1 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the fourth infusion cycle. |
| Secondary | Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | Part 1 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the first infusion cycle. |
| Secondary | Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the Fourth Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle. | Part 1 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the fourth infusion cycle. |
| Secondary | Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | Part 1 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle. |
| Secondary | Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the Fourth Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle. | Part 1 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the fourth infusion cycle. |
| Secondary | Part 2 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | Part 2 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the first infusion cycle. |
| Secondary | Part 2 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | Part 2 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the first infusion cycle. |
| Secondary | Part 2 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | Part 2 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle. |
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/NCT03468426/registered