Trial · NCT02418000
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of E6201 | Up to 6 weeks for each dose cohort | Phase 1 (Safety Run-In) was conducted in 5 dose cohorts in up to 30 subjects in a standard 3+3 dose-escalation design to establish an MTD and recommended Phase 2 dose (RP2D). Safety assessed through the monitoring of adverse events (AEs), serious adverse events (SAEs), clinical laboratory parameters (hematology and serum chemistry), vital sign measurements, electrocardiograms (ECGs) and physical examinations. |
| Primary | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Up to 6 weeks for each dose cohort | A DLT was defined as any one of the following events: prolonged myelosuppression (as defined by the National Cancer Institute \[NCI\] criteria specific for leukemia, i.e., marrow cellularity \< 5% at ≥ 6 weeks from start of therapy without evidence of leukemia); ≥ Grade 3 non-hematologic toxicity (excluding Grade 3 nausea, vomiting or diarrhea that is adequately controlled with supportive care and resolves to ≤ Grade 2 within 48 hours, or Grade 3 electrolyte disturbances responsive to correction within 24 hours); ≥ Grade 3 liver function tests (LFTs) lasting \> 7 days; treatment interruption \> 14 days due to toxicity; or other important medical event. DLTs were collected to determine the MTD which is defined as the dose level below the dose at which ≥ 2 of 6 patients in a dose cohort experienced a DLT. |
| Secondary | Overall Response Rate | At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug | For acute myeloid leukemia (AML): Revised Recommendations of the International Working Group (IWG) Response Criteria for AML: CR: Free of leukemia-related symptoms, absolute neutrophil count (ANC) \> 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, normal bone marrow with \< 5% blasts and no Auer rods. CRi: As per CR but w/ residual thrombocytopenia (platelet count \<100 x 10\^9/L) or residual neutropenia (ANC \<1.0 x 10\^9/L). PR: ≥50% decrease bone marrow blasts to 5 - 25% abnormal cells, or CR w/ ≤ 5% blasts if Auer rods present. For myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML): Modified IWG Response Criteria for MDS: CR: Free of leukemia-related symptoms, ANC ≥1.0 x 10\^9/L, platelet count ≥100 x 10\^9/L, bone marrow ≤5% myeloblasts, normal maturation of all cell lines, hemoglobin ≥ 11g/dL, no blasts in the peripheral blood. PR: All CR criteria w/ ≥50% decrease in bone marrow blasts over pre-treatment, but still \> 5%. |
| Secondary | Duration of Response | At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug | Length of time from the first evidence of objective response to the first evidence of progression |
| Secondary | Progression-Free Survival | From Cycle 1 Day 1 (C1D1) until death or study closure, up to 26 months | Length of time from the date of first administration of study drug to the first evidence of disease progression or death, whichever is earlier |
| Secondary | Overall Survival | From C1D1 until death or study closure, up to 26 months | Length of time from the date of first administration of study drug to the date of death from any cause |
| 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. | Cmax: Maximum measured plasma concentration over the collection period |
| 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. | Tmax: Time to maximum measured plasma concentration |
| 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. | Area under the plasma concentration versus time curve (AUC) to the last measurable concentration over the sampling time-interval. |
| 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. | AUCI: The area under the concentration versus time curve from time 0 to infinity |
| 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. | T1/2: The apparent first-order elimination half-life |
| 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. | Clearance observed (CLobs): Total body clearance for extravascular administration |
| 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. | Measurement of apparent volume of distribution observed (VDobs) |
| Secondary | Number of Participants With Suppression of pERK at 4 Hours Post-dose | Cycle 1 Day 1, 4 hours post-dose. | phospho-ERK (pERK) in blood assessed by Western blot at 4 hours post-dose |
| Secondary | Number of Participants With Suppression of pERK at 24 Hours Post-dose | Cycle 1 Day 1, 24 hours post-dose. | Measurement of phospho-ERK (pERK) in blood assessed by Western blot at 24 hours post-dose |
| Secondary | Number of Participants With Suppression of pFLT3 at 4 Hours Post-dose | Cycle 1 Day 1, 4 hours post-dose. | phospho-FLT3 (pFLT3) in blood assessed by Western blot at 4 hours post-dose |
| Secondary | Number of Participants With Suppression of pFLT3 at 24 Hours Post-dose | Cycle 1 Day 1, 24 hours post-dose. | phospho-FLT3 (pFLT3) in blood assessed by Western blot at 24 hours post-dose |
| Secondary | Number of Participants With Suppression of pAKT at 4 Hours Post-dose | Cycle 1 Day 1, 4 hours post-dose. | phospho-AKT (pAKT) in blood assessed by Western blot at 4 hours post-dose |
| Secondary | Number of Participants With Suppression of pAKT at 24 Hours Post-dose | Cycle 1 Day 1, 24 hours post-dose. | phospho-AKT (pAKT) in blood assessed by Western blot at 24 hours post-dose |
| Secondary | Number of Participants With Suppression of pERK by PIA at 4 Hours Post-dose | Cycle 1 Day 1, 4 hours post-dose. | Blood assay: Plasma inhibitory assay (PIA) measuring pERK in blood at 4 hours post-dose |
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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