Trial · NCT07226986
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: Incidence rate of Dose-limiting toxicities (DLTs) | Up to 42 days after the first AAA617 dose administration | Incidence of dose limiting toxicities (DLTs) with AMO959 in combination with AAA617 +/- ARPI A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the evaluation period and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. |
| Primary | Phase Ib: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From date of start of study treatment, assessed up to approximately 45 months | Incidence of adverse events by type, frequency, and severity, as graded by the NCI CTCAE version 5.0. |
| Primary | Phase Ib: Number of Participants with dose adjustments | From date of start of study treatment, assessed up to approximately 24 months | The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation). |
| Primary | Phase Ib: Dose Intensity | From date of start of study treatment, assessed up to approximately 24 months | Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity). |
| Primary | Phase Ib: Duration of exposure to each study drug | From date of start of study treatment, assessed up to approximately 24 months | Duration of exposure (in months) to each study drug. |
| Primary | Phase II: Biochemical Response (PSA50) | From date of start of study treatment, assessed up to approximately 24 months | Biochemical response (PSA50), defined as the proportion of participants who achieved a ≥ 50% decrease in PSA from baseline at any time during the treatment period prior to start of new anti-cancer therapy that is confirmed by a second PSA measurement ≥ 4 weeks later. |
| Secondary | Prostate Specific Antigen 90 (PSA90) response | From date of start of study treatment, assessed up to approximately 24 months | PSA90 response is defined as the proportion of participants who have achieved a ≥ 90% decrease in PSA from baseline at any time during the treatment period prior to start of new anti-cancer therapy that is confirmed by a second PSA measurement ≥4 weeks later. |
| Secondary | Phase Ib: Prostate Specific Antigen 50 (PSA50) response | From date of start of study treatment, assessed up to approximately 24 months | PSA50 response is defined as the proportion of participants who have achieved a ≥ 50% decrease in PSA from baseline at any time during the treatment period prior to the start of new anti-cancer therapy, confirmed by a second PSA measurement ≥4 weeks later. |
| Secondary | Phase Ib and Phase II: Radiographic progression-free survival (rPFS) | From date of start of study treatment (Phase Ib) / randomization (Phase II), assessed up to approximately 24 months | Radiographic progression- free survival (rPFS) is defined as the time from the date of start of study treatment (Phase Ib) / randomization (Phase II) to the date of first documented radiographic disease progression using conventional imaging and Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 criteria (Scher et al 2016) or death due to any cause, whichever occurs first. |
| Secondary | Phase Ib and Phase II: Overall Response Rate (ORR) | From date of start of study treatment (Phase Ib) / randomization (Phase II), assessed up to approximately 24 months | Overall Response Rate (ORR) is defined as the proportion of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) in soft tissue based on tumor response data and according to PCWG3-modified RECIST v1.1, in the absence of bone progression as per PCWG3. |
| Secondary | Phase Ib and Phase II: Disease control rate (DCR) | From date of start of study treatment (Phase Ib) / randomization (Phase II), assessed up to approximately 24 months | Disease control rate (DCR) is defined as the proportion of participants with a BOR of confirmed CR or PR, stable disease (SD) or Non-CR/Non- progressive disease (PD) in soft tissue based on tumor response data and according to PCWG3-modified RECIST v1.1, in the absence of bone progression as per PCWG3. |
| Secondary | Phase Ib and Phase II: Duration of Response (DoR) | From date of start of study treatment (Phase Ib) / randomization (Phase II), assessed up to approximately 24 months | Duration of Response (DoR) is defined as the duration of time between the date of first documented response (CR or PR) according to PCWG3- modified RECIST v1.1, in the absence of bone progression as per PCWG3, based on tumor response data and the date of first documented radiographic progression in soft tissue or death due to any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | From date of start of study, assessed up to approximately 45 months | Overall Survival (OS) is defined as the time from the date of start of study treatment (Phase Ib) / randomization (Phase II) to the date of death due to any cause. |
| Secondary | Phase II: Time to soft tissue progression (TTSTP) | From date of start of study randomization, assessed up to approximately 24 months | Time to soft tissue progression (TTSTP) is defined as time from randomization to the date of first documented radiographic soft tissue progression per PCWG3-modified RECIST v1.1. |
| Secondary | Phase Ib: Plasma concentrations of AMO959 | Throughout run-in periods and first cycle with AAA617, assessed up to 6 months | AMO959 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms |
| Secondary | Phase Ib: Plasma concentrations of AAA617 | Throughout treatment periods with AAA617, assessed up to 6 months | AAA617 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms |
| Secondary | Phase Ib: Time activity curves (TACs) for AAA617 | Throughout treatment periods with AAA617, assessed up to 6 months | Time Activity Curves (TAC) will be generated by plotting concentrations against time. |
| Secondary | Phase Ib: Absorbed radiation doses in selected organs and tumor lesions for AAA617 | Throughout treatment periods with AAA617, assessed up to 6 months | The organ absorbed radiation dose and effective radiation dose will be evaluated. |
| Secondary | Phase II: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From date of start of study treatment, assessed up to approximately 45 months | Incidence of adverse events by type, frequency, and severity, as graded by the NCI CTCAE version 5.0. |
| Secondary | Phase II: Number of Participants with dose adjustments | From date of start of study treatment, assessed up to approximately 24 months | The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation). |
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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