Trial · NCT03284957
Outcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Cycle 1 Day 1 to Cycle 1 Day 28 (cycle duration=28 days) | The DLT-evaluable population included participants who received 1 cycle (28 days, oral administration), with intake of at least 75% of intended doses, unless they discontinued study treatment before Cycle 1 completion due to a DLT, and in Part A had an evaluable 18F-fluorestradiol (18F-FES) positron emission tomography (PET) scan at baseline and between Days 11 and 15 of first cycle. Any participant who developed a DLT in Part A despite absence of evaluable 18F-FES-PET scan was also included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Objective Response Rate (ORR) as Determined by Independent Central Review (ICR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. | percentage of participants | NUMBER |
| PRIMARY | Parts D, I: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 232 weeks for Part D and 11 weeks for Part I | The safety population included all registered participants exposed to the study treatment, regardless of the amount of treatment administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parts A, B, C, F, H, J: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | From first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 94, 282, 144, 96, 59, 130 weeks for Parts A, B, C, F, H, J respectively | The safety population included all registered participants exposed to the study treatment, regardless of the amount of treatment administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parts A, B, C, D, F, H, I, J: Objective Response Rate as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. | percentage of participants | NUMBER |
| SECONDARY | Parts A, B, C, D, F, H, I, J: Clinical Benefit Rate (CBR) as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. | percentage of participants | NUMBER |
| SECONDARY | Part B: Clinical Benefit Rate as Determined by Independent Central Review | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. | percentage of participants | NUMBER |
| SECONDARY | Parts A, B, C, D, F, H, I, J: Duration of Response (DOR) as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with CR or PR (responders) were included in the analysis. | weeks | MEDIAN |
| SECONDARY | Part B: Duration of Response as Determined by Independent Central Review | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with CR or PR (responders) were included in the analysis. | weeks | MEDIAN |
| SECONDARY | Parts A, B, C, D, F, H, I, J: Progression-Free Survival (PFS) as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. | weeks | MEDIAN |
| SECONDARY | Parts A, B, C, D: Objective Response Rate as Determined by Investigators/Local Radiologists According to Estrogen Receptor 1 (ESR1) Mutation at Baseline | From Baseline (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228 weeks for Parts A, B, C, D respectively | Analysis was performed on the efficacy population. As pre-specified in statistical analysis plan (SAP), analysis was performed on pooled population \[Part A and B: Amcenestrant (Dose \>20 mg); Parts C and D: Amcenestrant 200 mg + Palbociclib 125 mg\] based on the pharmacodynamic effect to maximize sample size within each arm to provide more robust estimates. Only participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
| SECONDARY | Part B: Objective Response Rate as Determined by Independent Central Review According to Estrogen Receptor 1 Mutation at Baseline | Baseline (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
| SECONDARY | Parts A, B, C, D: Clinical Benefit Rate as Determined by Investigators/Local Radiologists According to Estrogen Receptor 1 Mutation at Baseline | From Baseline (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228 weeks for Parts A, B, C, D respectively | Analysis was performed on the efficacy population. As pre-specified in SAP, analysis was performed on pooled population \[Part A and B: Amcenestrant (Dose \>20 mg); Parts C and D: Amcenestrant 200 mg + Palbociclib 125 mg\] based on the pharmacodynamic effect to maximize sample size within each arm to provide more robust estimates. Only participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
| SECONDARY | Parts B, D, I: Time to First Confirmed Response as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with CR or PR (responders) were included in the analysis. | weeks | MEDIAN |
| SECONDARY | Part B: Time to First Confirmed Response as Determined by Independent Central Review | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with CR or PR (responders) were included in the analysis. | weeks | MEDIAN |
| SECONDARY | Part A: Number of Participants With 18F-Fluorestradiol Positron Emission Tomography Percentage Reduction | Baseline (within 3 days or more prior to Day 1) and between Day 11 and Day 15 of Cycle 1 (cycle duration=28 days) | The safety population included all registered participants exposed to the study treatment, regardless of the amount of treatment administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parts A, B, C, D, H, I, J: Time Interval Between Administration and the Sampling Preceding the First Concentration Above the Lower Limit of Quantification (LLOQ) (Tlag) of Amcenestrant After a Single Oral Administration | Cycle 1 Day 1 (cycle duration=28 days) | The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoint are reported. | hour | MEDIAN |
| SECONDARY | Parts A, B, C, D, H, I, J: Time to Reach Maximum Plasma Concentration (Tmax) of Amcenestrant After a Single Oral Administration | Cycle 1 Day 1 (cycle duration=28 days) | The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoint are reported. | hour | MEDIAN |
| SECONDARY | Parts A, B, C, D, H, I, J: Maximum Plasma Concentration (Cmax) of Amcenestrant After a Single Oral Administration | Cycle 1 Day 1 (cycle duration=28 days) | The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoint are reported. | ng/mL | MEAN |
| SECONDARY | Parts A, B, C, D, H, I, J: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Dosing Interval (AUC0-tau) of Amcenestrant After a Single Oral Administration | Cycle 1 Day 1 (cycle duration=28 days) | The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoint are reported. | ng*h/mL | MEAN |
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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