Trial · NCT06784752
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) centrally assessed by Blinded Independent Review Committee (BIRC) | After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start | PFS is defined as the time from randomization to the first occurrence of progression (centrally assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1) or death due to any cause. |
| Secondary | Time to Deterioration (TDD) (Key Secondary) | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | Time to deterioration is defined as the time from randomization to the first occurrence of a deterioration compared to the baseline scores or death from any cause for each of the following domains (tested separately) of EORTC QLQ-GI.NET21 \[gastrointestinal scale (GI scale)\] and EORTC QLQ-C30 questionnaires (fatigue, diarrhea, and global health scale). |
| Secondary | Progression Free Survival (PFS) | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | PFS is defined as the time from randomization to the first occurrence of progression (Investigator assessed according to RECIST v1.1) or death due to any cause. |
| Secondary | Objective Response Rate (ORR) | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | ORR: Rate of participants with best overall response (BOR) of partial response (PR) or complete response (CR) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC). |
| Secondary | Disease Control Rate (DCR) | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | DCR: Rate of participants with BOR of PR, CR or stable disease (SD) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC). |
| Secondary | Duration of Response (DOR) | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | DOR: The time from initially meeting the criteria for response (CR or PR) until the time of progression according to RECIST v1.1 or death due to underlying disease only. |
| Secondary | Overall Survival (OS) | Until 60 month from randomization | OS: Time from the randomization date until the date of death due to any cause. |
| Secondary | Time to Deterioration (TDD) | At the time of primary PFS analysis after observing approximately 88 PFS events per BIRC assessment | TTD is the time from randomization to the first occurrence of a deterioration compared to the baseline scores or death from any cause for EORTC QLQ-G.I.NET21 and EORTC QLQ-C30 domains not included among key secondary endpoints. |
| Secondary | Absolute change from baseline in EORTC QLQ-G.I.NET21 domain | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | Quality of Life assessed by EORTC QLQ-G.I.NET21 (excluding GI scale) (domains not included as key secondary objectives) |
| Secondary | Absolute change from baseline in the EQ-5D-5L index at each time point | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | Quality of Life assessed by EQ-5D-5L |
| Secondary | Absolute change from baseline in EORTC QLQ-C30 domain | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start. | Quality of Life assessed by EORTC QLQ-C30 (domains not included as key secondary objectives) |
| Secondary | Dosimetry | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | Absorbed radiation dose in selected organs, tumor lesions and total body |
| Secondary | Pharmacokinetic (PK) parameter: Area Under Curve (AUC) from [177Lu]Lu-DOTA-TATE blood radioactivity data | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1). The AUC from time zero to infinity (mass x time x volume-1) |
| Secondary | PK parameter: Clearance from [177Lu]Lu-DOTA-TATE blood radioactivity data | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | Clearance is the total body clearance of drug from the plasma or blood (volume x time-1). |
| Secondary | PK parameter: Distribution volume (Vz) from [177Lu]Lu-DOTA-TATE blood radioactivity data | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | The apparent volume of distribution during terminal phase (associated with λz) (volume) |
| Secondary | PK parameter: half-life (T1/2) from [177Lu]Lu-DOTA-TATE blood radioactivity data | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives |
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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