Trial · NCT01214655
A Study for Patients With Acute Leukemia
NCT01214655, Phase 1, Terminated, Eli Lilly and Company; results first posted 2019-05-13
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ConductScience Library. A Study for Patients With Acute Leukemia. Trials, record NCT01214655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01214655
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Patients With Acute Leukemia
- NCT number
- NCT01214655
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 33 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Acute Leukemia
- Interventions
- LY2523355
- First posted
- 2010-10-05
- Last updated
- 2019-05-13
- Results first posted
- 2019-05-13
- Limitations and caveats
Before MTD could be determined for Part B (Days 1, 5, and 9 of a 21-day cycle), this study was paused for futility analysis. The decision was made to close the study because of evident toxicity and lack of efficacy.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Dose and Schedule for Phase 2 Studies in Acute Leukemia | Baseline up to the end of Cycle 2 (Day 42) | The recommended dose and schedule for Phase 2 studies of LY2523355 with acute leukemia was determined by a modification of the continual reassessment method. The sample size to adequately determine the maximum tolerated dose (MTD) for both schedules in this study was a function of a priori estimates for the dose-toxicity relationship as well as the initial dose in each schedule, the rate of dose escalation, and the observed dose-toxicity relationship. Before MTD could be determined for Part B (Days 1, 5, and 9 of a 21-day cycle), this study was paused for futility analysis. |
| Secondary | Number of Participants With Clinically Significant Effects | Baseline up to study completion (up to 213 days) | Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Secondary | Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose | Cycle 1(Day 1),: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose | The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355 were calculated to assess intra and intercycle variability, depending on dosage cycle. |
| Secondary | Pharmacokinetics, Maximum Plasma Concentration (Cmax), Multiple Dose | Days 3 (Parts A or C) or 9 (Part B), Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose | The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355. Multiple dose LY2523355 plasma Cmax values are shown at each dose level for both schedules of administration (Day 3 of Cycle 1 for the Day 1, 2, and 3 schedule of administration and Day 9 of Cycle 1 for the Days 1, 5, and 9 schedule of administration). The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355 were calculated to assess intra and intercycle variability, depending on dosage cycle. |
| Secondary | Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC), Single Dose | Day 1, Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose | The AUC(0-24) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to 24 hours. The AUC(0-inf) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to infinity. Single dose LY2523355 AUC values are shown for each dose level for Day 1 of Cycle 1 for both schedules of administration. When only individual participant parameters are available or N=2, for a given dose, the AUC CV is not calculated for that dose group and is not presented (4 milligrams per meter squared per day \[mg/m\^2/day\], 14 mg/m\^2/day, 12 mg/m\^2/day and 16 mg/m\^2/day). Individual data will be presented. |
| Secondary | Pharmacokinetics, Area Under the Concentration Versus Time (AUC), Multiple Dose | Days 3 (Parts A or C) or 9 (Part B):Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr 48 hr, 72 hr postdose | The AUC(0-24) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to 24 hours. The AUC(0-inf) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to infinity.. Multiple dose LY2523355 AUC values are shown at each dose level for both schedules of administration (Day 3 of Cycle 1 for the Day 1, 2, and 3 schedule of administration and Day 9 of Cycle 1 for the Days 1, 5, and 9 schedule of administration). When only individual participant parameters are available or N=2, for a given dose, the AUC CV is not calculated for that dose group and is not presented (4 milligrams per meter squared per day \[mg/m\^2/day\], 12 mg/m\^2/day, and 14 mg/m\^2/day). Individual data will be presented. |
| Secondary | Percentage of Participants With a Response for Acute Myelogenous Leukemia Using The Revised International Working Group Criteria | Baseline up to disease progression or discontinuation (up to 213 days) | Response rate for participants with acute myelogenous leukemia include the proportion of participants who achieved a morphologic complete remission, morphologic complete remission with incomplete blood count recovery, cytogenetic complete remission, molecular complete remission, or partial remission. The Revised International Working Group Criteria was used to determine response rate for participants with acute myelogenous leukemia. |
| Secondary | Response Rates for Chronic Myelogenous Leukemia in Blast Crisis (Complete Hematologic Response, no Evidence of Leukemia, Return to Chronic Phase) | Baseline up to disease progression or discontinuation (up to 213 days) | Response rate for participants with chronic myelogenous leukemia in blast crisis include the proportion of participants who achieved a complete hematologic response, had no evidence of leukemia, or had returned to chronic phase. The criteria outlined in Cohen 2005 (Cohen MH, Johnson JR, Pazdur R. 2005. U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval. Clin Cancer Res. 11(1):12-19.) was used to determine response rate for participants with chronic myelogenous leukemia in blast crisis. |
| Secondary | Response Rate (Percentage) for Acute Lymphoblastic Leukemia Using The Revised International Working Group Criteria | Baseline up to disease progression or discontinuation (up to 213 days) | Response rate for participants with acute lymphoblastic leukemia include the proportion of participants who achieved a morphologic complete remission, morphologic complete remission with incomplete blood count recovery, cytogenetic complete remission, molecular complete remission, or partial remission. The Revised International Working Group Criteria was used to determine response rate for participants with acute lymphoblastic leukemia by early treatment assessment, morphologic leukemia-free state (less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells) and morphologic complete remission (and have an absolute neutrophil count of more than 1000 per microliter and platelets of 100,000 per microliter. |
| Other | Death of Participants on Study up to the Follow-up Period | Baseline up to end of treatment follow-up (up to 213 days) | The number of participants who died through the follow-up period of the study. This does not include the outcomes for the two participants who died while on treatment through Cycle 2 as captured in the Participant Flow Table. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Dose and Schedule for Phase 2 Studies in Acute Leukemia | Baseline up to the end of Cycle 2 (Day 42) | Participants who received at least one dose of study medication (LY2523355). | mg/m^2/day; Days 1, 2, and 3 | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Effects | Baseline up to study completion (up to 213 days) | Participants who received at least one dose of study medication (LY2523355). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose | Cycle 1(Day 1),: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose | Participants who received one dose of LY2523355 on Day 1 of Cycle 1(Schedule A,B,C) with evaluable pharmacokinetic data to enable determination of the LY2523355 plasma Cmax on Day 1. Schedule A,C data was combined for 5 mg, 2 participants received and incorrect dose of 6 mg and 16 mg are included in data. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics, Maximum Plasma Concentration (Cmax), Multiple Dose | Days 3 (Parts A or C) or 9 (Part B), Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose | Participants who received more than one dose of LY2523355 with evaluable pharmacokinetic data, Schedules A,B,C. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC), Single Dose | Day 1, Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose | Participants who received one dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC on Day 1 of Cycle 1.Schedule A,C data was combined for 5 mg, 2 participants received and incorrect dose of 6 mg and 16 mg are included in data. | nanagram hours per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics, Area Under the Concentration Versus Time (AUC), Multiple Dose | Days 3 (Parts A or C) or 9 (Part B):Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr 48 hr, 72 hr postdose | Participants who received more than one dose of LY2523355 with evaluable pharmacokinetic data on Cycle 1 Day 3 or Day 9, schedule dependent. | nanograms hours per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With a Response for Acute Myelogenous Leukemia Using The Revised International Working Group Criteria | Baseline up to disease progression or discontinuation (up to 213 days) | Participants with acute myelogenous leukemia who received at least one dose of study medication (LY2523355). | percentage of responders | NUMBER |
| SECONDARY | Response Rates for Chronic Myelogenous Leukemia in Blast Crisis (Complete Hematologic Response, no Evidence of Leukemia, Return to Chronic Phase) | Baseline up to disease progression or discontinuation (up to 213 days) | Participants with chronic myelogenous leukemia in blast crisis who received at least one dose of study medication (LY2523355). | percentage of responders | NUMBER |
| SECONDARY | Response Rate (Percentage) for Acute Lymphoblastic Leukemia Using The Revised International Working Group Criteria | Baseline up to disease progression or discontinuation (up to 213 days) | Participants with acute lymphoblastic leukemia who received at least one dose of study medication (LY2523355). | percentage of responders | NUMBER |
| OTHER_PRE_SPECIFIED | Death of Participants on Study up to the Follow-up Period | Baseline up to end of treatment follow-up (up to 213 days) | Participants who received at least one dose of study medication (LY2523355). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Dose and Schedule for Phase 2 Studies in Acute Leukemia | LY2523355 | 5 | mg/m^2/day; Days 1, 2, and 3 | ||
| Number of Participants With Clinically Significant Effects | Schedule A LY2523355 | 7 | Participants | ||
| Number of Participants With Clinically Significant Effects | Schedule B LY2523355 | 9 | Participants | ||
| Number of Participants With Clinically Significant Effects | Schedule C LY2523355 | 4 | Participants | ||
| Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose | Schedule A 2 mg LY2523355 | 198 | Geometric Coefficient of Variation 1410 | nanograms per milliliter (ng/mL) | |
| Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose | Schedule A 4 mg LY2524455 | 895 | Geometric Coefficient of Variation NA | nanograms per milliliter (ng/mL) | |
| Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose | Schedule A,C 5 mg LY2523355 | 240 | Geometric Coefficient of Variation 420 | nanograms per milliliter (ng/mL) | |
| Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose | Schedule A 6 mg LY2523355 | 391 | Geometric Coefficient of Variation 254 | nanograms per milliliter (ng/mL) | |
| Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose | Schedule B 8 mg LY2523355 | 169 | Geometric Coefficient of Variation 47 | nanograms per milliliter (ng/mL) | |
| Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose | Schedule B 10 mg LY2523355 | 354 | Geometric Coefficient of Variation 66 | nanograms per milliliter (ng/mL) |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Schedule A LY2523355 | 10 | |
| Part A | STARTED | Schedule B LY2523355 | 0 | |
| Part A | STARTED | Schedule C LY2523355 | 0 | |
| Part A | Received 2 mg Study Drug | Schedule A LY2523355 | 3 | |
| Part A | Received 2 mg Study Drug | Schedule B LY2523355 | 0 | |
| Part A | Received 2 mg Study Drug | Schedule C LY2523355 | 0 | |
| Part A | Escalated From 2 to 4 mg/m²/Day | Schedule A LY2523355 | 3 | |
| Part A | Escalated From 2 to 4 mg/m²/Day | Schedule B LY2523355 | 0 | |
| Part A | Escalated From 2 to 4 mg/m²/Day | Schedule C LY2523355 | 0 | |
| Part A | Joined 4 mg Group | Schedule A LY2523355 | 1 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events585
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3 | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3 | 1 | 4 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | 1 | 2 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3 | 3 | 5 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9 | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9 | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9 | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9 | 1 | 4 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | 3 | 8 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3 | 0 | 3 | 0 |
1 to 10 of 585Source ClinicalTrials.gov
See all 585 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3 | ||
| Total, all-cause mortality | Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3 | ||
| Total, all-cause mortality | Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | ||
| Total, all-cause mortality | Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3 | ||
| Total, all-cause mortality | Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9 | ||
| Total, all-cause mortality | Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9 | ||
| Total, all-cause mortality | Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9 | ||
| Total, all-cause mortality | Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9 | ||
| Total, all-cause mortality | Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | ||
| Total, other adverse events | Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3 | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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