Trial · NCT02418000
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of E6201 | Up to 6 weeks for each dose cohort | Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication | E6201 MTD (mg/m^2) IV twice weekly | NUMBER |
| PRIMARY | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Up to 6 weeks for each dose cohort | Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication. | Number of Participants with DLTs | NUMBER |
| SECONDARY | Overall Response Rate | At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug | The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure. | Objective Responses | NUMBER |
| SECONDARY | Duration of Response | At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug | The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure.~No objective responses were observed. Therefore, duration of response could not be calculated. | ||
| SECONDARY | Progression-Free Survival | From Cycle 1 Day 1 (C1D1) until death or study closure, up to 26 months | The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure.~For AML, MDS and CMML, progression was defined by relevant IWG criteria as failure to achieve at least a PR.~No responses; PFS could not be calculated. | ||
| SECONDARY | Overall Survival | From C1D1 until death or study closure, up to 26 months | The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified endpoint. | Days | MEDIAN |
| SECONDARY | Pharmacokinetic Profile of E6201 in Plasma: Cmax | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetics of E6201 in Plasma: Tmax | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | h | MEAN |
| SECONDARY | Pharmacokinetic Profile of E6201 in Plasma: AUCT | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | h.ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Profile of E6201 in Plasma: AUCI | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | h.ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Profile of E6201 in Plasma: T1/2 | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | h | MEAN |
| SECONDARY | Pharmacokinetic Profile of E6201 in Plasma: CLobs | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | L/h | MEAN |
| SECONDARY | Pharmacokinetic Profile of E6201 in Plasma: VDobs | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | L | MEAN |
| SECONDARY | Number of Participants With Suppression of pERK at 4 Hours Post-dose | Cycle 1 Day 1, 4 hours post-dose. | All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Suppression of pERK at 24 Hours Post-dose | Cycle 1 Day 1, 24 hours post-dose. | All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Suppression of pFLT3 at 4 Hours Post-dose | Cycle 1 Day 1, 4 hours post-dose. | All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Suppression of pFLT3 at 24 Hours Post-dose | Cycle 1 Day 1, 24 hours post-dose. | All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Suppression of pAKT at 4 Hours Post-dose | Cycle 1 Day 1, 4 hours post-dose. | All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Suppression of pAKT at 24 Hours Post-dose | Cycle 1 Day 1, 24 hours post-dose. | All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Suppression of pERK by PIA at 4 Hours Post-dose | Cycle 1 Day 1, 4 hours post-dose. | All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative. | Participants | COUNT_OF_PARTICIPANTS |
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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