Trial · NCT07544056
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (Phase IIb) | From randomization until disease progression or end of treatment or death (up to 24 months). | Percentage of participants achieving complete response (CR) or partial response (PR) per RECIST v1.1. This is the primary endpoint for the Phase IIb and will be assessed by both independent review committee (IRC) and investigator (INV). |
| Primary | Overall Survival (OS) (Phase III) | From randomization until death (up to 48 months). | Defined as the time from the date of randomization to the date of death due to any cause. This is the primary endpoint for the Phase III. |
| Secondary | Objective Response Rate (ORR) per RECIST v1.1 (Phase III) | From randomization until disease progression or end of treatment or death (up to 24 months). | Proportion of participants achieving complete response (CR) or partial response (PR) per RECIST v1.1. Assessed by both IRC and INV for the Phase III. |
| Secondary | Progression-Free Survival (PFS) per RECIST v1.1 (Phase IIb and Phase III) | From randomization until disease progression or end of treatment or death (up to 24 months). | Time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause. Assessed by both IRC and INV for the Phase IIb and Phases III. |
| Secondary | Disease Control Rate (DCR) per RECIST v1.1 (Phase IIb and Phase III) | From randomization until disease progression or end of treatment or death (up to 24 months). | Percentage of participants achieving CR, PR, or stable disease (SD) per RECIST v1.1. Assessed by both IRC and INV for the Phase IIb and Phases III. |
| Secondary | Duration of Response (DoR) per RECIST v1.1 (Phase IIb and Phase III) | From the date of the first documented objective response (CR or PR) until the first documented disease progression or death (up to 24 months). | Time from the first documented objective response (CR or PR) to the first documented disease progression or death. Assessed by both IRC and INV for the Phase IIb and Phases III. |
| Secondary | Overall Survival (OS) (Phase IIb) | From randomization until death (up to 48 months). | Time from the date of randomization to the date of death due to any cause. This endpoint is applicable to Phase IIb. |
| Secondary | Change from Baseline in Health-Related Quality of Life (HRQoL) (Phase IIb and Phase III) | Baseline, then at each chemotherapy visit (every 21-day cycle), at the end of treatment, and every 3 months during follow-up until death or withdrawal (up to 24 months). | Change from Baseline in HRQoL. Assessed by Quality of Life Instruments for Cancer Patients-Breast Cancer (QLICP-BR) version 2.0 (v2.0) in both Phase IIb and Phase III. |
| Secondary | Adverse Events (AE) and Serious Adverse Events (SAE) (Phase IIb and Phase III) | From signing of informed consent until 30 days after the last dose. | Incidence, severity (graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0 (v6.0), and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs) in the Phase IIb and Phase III. |
| Secondary | Maximum Plasma Concentration (Cmax) of BEBT-209 and its major Metabolites | C1D1 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D2 (1, 2, 4, 8, 12, 24, 36h post-dose). | The peak plasma concentrations (Cmax) of BEBT-209 and its major metabolites on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 2 (C1D2) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb pharmacokinetic (PK) substudy. |
| Secondary | Time to reach Cmax (Tmax) of BEBT-209 and its major metabolites | C1D1 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D2 (1, 2, 4, 8, 12, 24, 36h post-dose). | The time to maximum plasma concentration (Tmax) of BEBT-209 and its major metabolites on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 2 (C1D2 ) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy. |
| Secondary | Terminal Elimination Half-life (t1/2) of BEBT-209 and its major metabolites | C1D1 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D2 (1, 2, 4, 8, 12, 24, 36h post-dose). | The time required for the plasma concentration of BEBT-209 and its major metabolites to decrease by half on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 2 (C1D2 ) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy. |
| Secondary | Area Under the Concentration-Time Curve (AUC) of BEBT-209 and its major Metabolites | Cycle 1 Day 1 (C1D1 ) (pre-dose, 1h, 2h, 4h, 6h post-dose) and Cycle 1 Day 2 (C1D2) (1, 2, 4, 8, 12, 24, 36h post-dose). | PK parameters calculated from blood concentration-time curves of BEBT-209 and its major Metabolites, Includes AUC from 0 to 36 hours (AUC0-36h), AUC from 0 to last measurable concentration (AUC0-t), and AUC from 0 to infinity (AUC0-∞). Applicable only to participants enrolled in the Phase IIb PK substudy. |
| Secondary | Steady-state Maximum Concentration (Cmin,ss) of BEBT-209 and its major metabolites | C1D8 (pre-dose). | The Cmin,ss of BEBT-209 and its major metabolites on Cycle 1 Day 8 (C1D8) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy. |
| Secondary | Steady-state Maximum Concentration (Cmax,ss) of BEBT-209 and its main metabolites | C1D8 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D9 (1, 2, 4, 8, 12, 24, 36h post-dose). | The maximum plasma concentration of BEBT-209 and its main metabolites observed during a dosing interval at steady state on Cycle 1 Day 8 (C1D8) and Cycle 1 Day 9 (C1D9) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy. |
| Secondary | Average Steady-state Plasma Concentration (Cav,ss) of BEBT-209 and its major metabolites | C1D8 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D9 (1, 2, 4, 8, 12, 24, 36h post-dose). | The average concentration of BEBT-209 and its major metabolites in plasma over a dosing interval at steady state on Cycle 1 Day8 (C1D8) and Cycle 1 Day 9 (C1D9 ) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy. |
| Secondary | Steady-state Elimination Half-life (t1/2,ss) of BEBT-209 and its metabolites | C1D8 (pre-dose, 1h, 2h, 4h, 6h post-dose) and C1D9 (1, 2, 4, 8, 12, 24, 36h post-dose). | The terminal elimination half-life of BEBT-209 and its metabolites measured under steady-state conditions on Cycle 1 Day8 (C1D8) and Cycle 1 Day 9 (C1D9) of each 21-day treatment cycle. Applicable only to participants enrolled in the Phase IIb PK substudy. |
| Secondary | Area Under the Concentration-Time Curve steady-state (AUCss) of BEBT-209 and its Metabolites | Cycle 1 Day8 (C1D8) (pre-dose, 1h, 2h, 4h, 6h post-dose) and Cycle 1 Day 9 (C1D9 ) (1, 2, 4, 8, 12, 24, 36h post-dose). | PK parameters calculated from blood concentration-time curves of BEBT-209 and its major Metabolites at steady-state, Includes AUC from 0 to last measurable concentration at steady-state (AUC0-t,ss), AUC from 0 to infinity at steady-state (AUC0-∞,ss). Applicable only to participants enrolled in the Phase IIb PK substudy. |
| Secondary | Biomarker Analysis (Phase IIb and Phase III) | Baseline and at disease progression (up to 36 months) | Correlation of biomarker expression (e.g., programmed death-ligand 1 \[PD-L1\], Breast Cancer Gene 1/2 \[BRCA1/2\] mutation status) with clinical efficacy and safety outcomes |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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