Trial · NCT06531499
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time activity curves (TACs) and absorbed radiation dose of AAA617 in organs | From Cycle 1 to Cycle 12; cycle = 42 days | Time activity curve (TAC) will be generated from the amount radioactivity in one given tissue. Time integrated activity coefficient and absorbed dose will be calculated |
| Primary | Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | For up to 12 cycles in taxane-naive participants with progressive PSMA-positive mCRPC with nrmal kidney function or mild renal impairment; cycle = 42 days | The distribution of adverse events for Radioligand Therapy (RLT) will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters. Adverse event monitoring should be continued for at least 42 days following the end of treatment (EOT) visit. Participants receiving the study treatment will continue to be followed for safety every 12 weeks during the long-term follow-up for selected adverse events |
| Primary | Percentage of participants with AAA617 dose reductions, interruptions and discontinuations | Up to 42 (+7) days after last AAA617 dose administration (Safety Follow-up) | The assessment of tolerability will be based on the frequency of participants with dose interruptions, reductions, and study treatment discontinuations. Dose reduction will be based on the worst toxicity demonstrated at the last dose. |
| Secondary | Time activity curves (TACs) and absorbed radiation dose AAA617 in tumors | For up to 12 cycles; cycle = 42 days | Time activity curves (TACs) will be generated from the amount of radioactivity in one given tissue at a given moment. TACs will be fitted to mono- and bi-exponential curves. Time integrated activity coefficient and absorbed dose will be calculated. |
| Secondary | Pharmacokinetic ( PK) concentration of AAA617 in blood over time | Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12, cycle = 42 days | PK concentrations will be listed by patient and visit/sampling time point. The descriptive summary statistics will be provided by visit/sampling time point. |
| Secondary | Pharmacokinetic (PK) parameter Cmax of AAA617 from blood radioactivity data | Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days | Derived PK parameter, Cmax will be listed by patient and visit. The descriptive summary statistics will be provided by visit. Cmax is the maximum drug concentration after dosing. |
| Secondary | PK parameter Tmax of AAA617 from blood radioactivity data | Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days | Derived PK parameter Tmax, will be listed by patient and visit. The descriptive summary statistics will be provided by visit. Tmax is the time to reach the maximum concentration. |
| Secondary | PK parameter AUC of AAA617 from blood radioactivity data | Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days | Derived PK parameter AUC will be listed by patient and visit. The descriptive summary statistics will be provided by visit. AUC: Area under the concentration-time curve. |
| Secondary | PK parameter CL of AAA617 from blood radioactivity data | Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days | Derived PK parameter CL will be listed by patient and visit. The descriptive summary statistics will be provided by visit. Clearance (CL): Rate at which the body eliminates the drug. |
| Secondary | PK parameter VZ of AAA617 from blood radioactivity data | Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days | Derived PK parameter Vz will be listed by patient and visit. The descriptive summary statistics will be provided by visit. Vz: volume of distribution during the terminal phase (Vz). |
| Secondary | PK parameter terminal T1/2 of AAA617 from blood radioactivity data | Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, and Cycle 12; cycle = 42 days | Derived PK parameter terminal T1/2 will be listed by patient and visit. The descriptive summary statistics will be provided by visit. T1/2: Terminal half life. |
| Secondary | Overall response rate (ORR) | From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months | ORR is defined as the proportion of participants with BOR of confirmed CR or PR per investigator assessment and according to Prostate Cancer Working Group 3 (PCWG3) modified-RECIST v1.1. |
| Secondary | Disease Control rate (DCR) | From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months | DCR is defined as the percentage of CR, PR, stable disease or non-CR/non-progressive disease (PD) per investigator assessment and according to PCWG3 modified-RECIST v1.1 assessment in soft tissue, lymph node, and visceral lesions. |
| Secondary | Duration of response (DOR) | From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months | DOR is defined as the duration of time between the date of the first documented BOR (CR or PR) per investigator assessment according to PCWG3 modified-RECIST v1.1 and the date of first documented progression or death due to any cause. |
| Secondary | Radiographic Progressive free survival (rPFS) | From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months | rPFS defined as the time from the date of first dose of study treatment to the date of the first documented radiographic disease progression as assessed by investigator and PCWG3 modified-RECIST v1.1 criteria or death due to any cause, whichever occurs first. |
| Secondary | Prostate specific antigen (PSA) response | Baseline, (Cycle (C), Day (D)) C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, C6D42, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, End Of Treatment (EOT), 6 weeks after EOT, every 12 weeks after EOT up to 12 months; each cycle = 42 days | PSA response is defined as percentage of participants who achieve any decrease from baseline that is confirmed by a second PSA measurement ≥4 weeks. Participants with any decrease in PSA will also be summarized by visit. |
| Secondary | Overall survival (OS) | Cycle 1 to death event, approx. 5 years, (cycle = 42 days) | Overall survival is defined as the time from the first dose of study treatment to death due to any cause. |
| Secondary | Duration of exposure to AAA617 and dose intensity | during treatment period (74 weeks) | Duration of exposure: Dose intensity is computed as the ratio of actual cumulative dose received and actual duration of exposure. |
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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