Trial · NCT03779113
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs) | From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (each cycle was 28 days) | The DLT evaluable analysis set was defined as all patients enrolled in the dose escalation stage of the study who were evaluable for DLT assessment. A patient was DLT evaluable if: had received at least 75% of the assigned dose of study treatment during the DLT assessment window or had not completed the DLT assessment period due to a DLT. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation | From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months | The FAS included all patients who received at least 1 dose of HMPL-523. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose Escalation Stage: Recommended Phase 2 Dose of HMPL-523 | From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (each cycle was 28 days) | The FAS included all patients who received at least 1 dose of HMPL-523. | mg | NUMBER |
| PRIMARY | Dose Expansion Stage: Objective Response Rate (ORR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The response evaluable set (RES) included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. | percentage of patients | NUMBER |
| PRIMARY | Dose Expansion Stage: Complete Response Rate | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. | percentage of patients | NUMBER |
| PRIMARY | Dose Expansion Stage: Clinical Benefit Rate (CBR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. | percentage of patients | NUMBER |
| PRIMARY | Dose Expansion Stage: Duration of Response (DOR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. Only patients with response of CR, CRi, PR, nPR, VGPR, PR-L, or MR were included in the analysis. | months | MEDIAN |
| PRIMARY | Dose Expansion Stage: Time to Response (TTR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. Only patients with response of CR, CRi, PR, nPR, VGPR, PR-L, or MR were included in the analysis. | months | MEDIAN |
| PRIMARY | Dose Expansion Stage: Progression-Free Survival (PFS) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The FAS included all patients who received at least 1 dose of HMPL-523. | months | MEDIAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Maximum Plasma Concentration (Cmax) of HMPL-523 | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1 | PK analysis set (PKAS) included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in statistical analysis plan (SAP), results are presented by disease groups and combined data for CLL and CLL-post BTK arms in dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Time to Reach Maximum Plasma Concentration (Tmax) of HMPL-523 | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1 | The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | hour (h) | MEDIAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Area Under the Concentration-Time Curve From Time Zero (Pre-Dose) to Time of Last Quantifiable Concentration (AUC0-t) of HMPL-523 | Dose escalation and dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 1 of Cycle 1 | The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | ng*h/mL | MEAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) of HMPL-523 | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1 | The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | ng*h/mL | MEAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Apparent Systemic Clearance (CL/F) of HMPL-523 | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1 | The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | Liter/h | MEAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Minimum Plasma Concentration (Cmin) of HMPL-523 | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1 | The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | ng/mL | MEAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Ratio of Metabolite to Parent Maximum Plasma Concentration (MRCmax) | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1 | The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | ratio | MEAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Ratio of Metabolite to Parent Area Under the Concentration-Time Curve During a Dosing Interval (MRAUCtau) | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1 | The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | ratio | MEAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Accumulation Ratio for Maximum Plasma Concentration (RA[Cmax]) of HMPL-523 | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1 | The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | ratio | MEAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Accumulation Ratio for Area Under the Concentration-Time Curve During a Dosing Interval (RA[AUC]) of HMPL-523 | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1 | The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | ratio | MEAN |
| SECONDARY | Dose Expansion Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation | From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months | The FAS included all patients who received at least 1 dose of HMPL-523. | Participants | COUNT_OF_PARTICIPANTS |
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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