Trial · NCT02698189
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Dose Limiting Toxicity (DLT) | From time of first dose up to the end of Cycle 1 (21-day cycle): up to 21 days | The population consisted of all participants that received at least 85% of the planned dose of study drug (18 days) or experienced a DLT during Cycle 1 (21-day cycle). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced At Least One Adverse Event (AE) | From time of first dose until the end of follow-up (up to 8 months) | The analysis population consisted of all participants who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Discontinued Study Treatment Due to an AE | From time of first dose until the end of treatment (up to 7 months) | The analysis population consisted of all participants who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the AML cohort who received at least one dose of study treatment and had data evaluable for ORR analysis. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the DLBCL cohort who received at least one dose of study treatment and had data evaluable for ORR analysis. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the AML cohort who received at least one dose of study treatment and had data evaluable for DOR analysis. DOR could not be calculated because no participants met criteria for analysis: CR or PR and documented disease progression or death. | ||
| SECONDARY | Duration of Response (DOR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the DLBCL cohort who received at least one dose of study treatment and had data evaluable for DOR analysis. DOR could not be calculated because no participants met criteria for analysis: CR or PR and documented disease progression or death. | ||
| SECONDARY | Disease Control Rate (DCR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the AML cohort who received at least one dose of study treatment and had data evaluable for DCR analysis. | Percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the DLBCL cohort who received at least one dose of study treatment and had data evaluable for DCR analysis. | Percentage of participants | NUMBER |
| SECONDARY | Observed Maximum Concentration (Cmax) of MK-8628 | Up to 22 days post MK-8628 dose | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for Cmax analysis. | ng/mL | MEAN |
| SECONDARY | Time to Maximum Concentration (Tmax) of MK-8628 | Up to 22 days post MK-8628 dose | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for the Tmax analysis. | hr | MEDIAN |
| SECONDARY | Observed Minimum Concentration (Cmin) of MK-8628 | Up to 22 days post MK-8628 dose | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for the Cmin analysis. | ng/mL | MEAN |
| SECONDARY | Area Under the Concentration-Time Curve of MK-8628 From Time 0 to Infinity (AUC 0-∞) | Up to 22 days post MK-8628 dose | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for the AUC 0-∞ analysis. | hr*ng/mL | MEAN |
| SECONDARY | Apparent Terminal Half-life (t1/2) for MK-8628 | Up to 22 days post MK-8628 dose | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for the t1/2 analysis. | hr | MEAN |
| SECONDARY | Apparent Total Body Clearance (CL/F) of MK-8628 | Up to 22 days post MK-8628 dose | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for CL/F analysis. | Liters/hr | MEAN |
| SECONDARY | Apparent Volume of Distribution During the Terminal Phase (Vz/F) of MK-8628 | Up to 22 days post MK-8628 dose | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for Vz/F analysis. | Liters | MEAN |
| SECONDARY | Change From Baseline in Bromodomain and Extra-Terminal Domain (BET) Protein Target Gene Expression at 3 Hours Postdose on Day 1 of Cycle 1 (21-day Cycle) | Baseline (predose on Day 1 of Cycle 1 [21-day cycle]) and 3 hours postdose on Day 1 of Cycle 1 (21-day cycle) | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received one dose of MK-8628 20 mg on Day 1 of Cycle 1 (21-day cycle) and had data available for the gene expression analysis. | Log2 scale fold change | MEAN |
| SECONDARY | Change From Baseline in Bromodomain and Extra-Terminal Domain (BET) Protein Target Gene Expression at 8 Hours Postdose on Day 1 of Cycle 1 (21-day Cycle) | Baseline (predose on Day 1 of Cycle 1 [21-day cycle]) and 8 hours postdose on Day 1 of Cycle 1 (21-day cycle) | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received one dose of MK-8628 20 mg on Day 1 of Cycle 1 (21-day cycle) and had data available for the gene expression analysis. | Log2 scale fold change | MEAN |
| SECONDARY | Change From Baseline in Bromodomain and Extra-Terminal Domain (BET) Protein Target Gene Expression at 12 Hours Postdose on Day 1 of Cycle 1 (21-day Cycle) | Baseline (predose on Day 1 of Cycle 1 [21-day cycle]) and 12 hours postdose on Day 1 of Cycle 1 (21-day cycle) | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received two doses of MK-8628 20 mg on Day 1 of Cycle 1 (21-day cycle) and had data available for the gene expression analysis. | Log2 scale fold change | MEAN |
| SECONDARY | Change From Baseline in Bromodomain and Extra-Terminal Domain (BET) Protein Target Gene Expression at Predose on Day 8 of Cycle 1 (21-day Cycle) | Baseline (predose on Day 1 of Cycle 1) and predose on Day 8 of Cycle 1 (21-day cycle) | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received 14 doses of MK-8628 20 mg by Day 8 of Cycle 1 (21-day cycle) and had data available for the gene expression analysis. | Log2 scale fold change | 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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