Trial · NCT01214603
A Study in Participants With Acute Leukemia
NCT01214603, Phase 2, Completed, Eli Lilly and Company; results first posted 2018-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Participants With Acute Leukemia. Trials, record NCT01214603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01214603
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Participants With Acute Leukemia
- NCT number
- NCT01214603
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Leukemia
- Interventions
- LY2090314
- First posted
- 2010-10-05
- Last updated
- 2018-11-19
- Results first posted
- 2018-11-19
- Limitations and caveats
- An interim data review was performed after 6 participants in the safety lead-in completed 1 cycle of therapy. Based on the interim safety results, the expansion cohort was not opened to enrollment.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)] | Drug-related events were defined as treatment-emergent serious and other non-serious AEs that were considered by the investigator to be related to study drug. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. |
| Secondary | Number of Participants With Best Response of Complete Response or Partial Response | Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles) | The Revised International Working Group criteria were used to determine the response for participants with acute myelogenous leukemia (AML). Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as \<5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100\*10\^9/Liter (L) and absolute neutrophil count (ANC) ≥1\*10\^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. |
| Secondary | Percentage of Participants With Best Response of Complete Response or Partial Response | Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles) | The Revised International Working Group criteria were used to determine the response for participants with AML. Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as \<5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100\*10\^9/L and ANC ≥1\*10\^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Percentage of participants=\[(number of participants with CR or PR)/(number of participants treated)\]\*100. |
| Secondary | Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to 8 Hours (h) Postdose [AUC(0-8)] | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] | AUC(0-8) was estimated from the plasma drug concentration time profile. |
| Secondary | PK: AUC From Time 0 to Infinity [AUC(0-inf)] | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] | AUC(0-inf) was estimated from the plasma drug concentration time profile. |
| Secondary | PK: Maximum Concentration (Cmax) | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] | Cmax is the maximum observed concentration estimated from the plasma drug concentration time profile. |
| Secondary | Percent Change From Predose Beta (β)-Catenin Levels | Cycle 1: D1 and D9 (predose, 1 h, 2 h, 4 h, 8 h, and 24 h after infusion started); Cycle 1: D5, D8, and D12 and C2 through C9: D1 (predose, 2 h after infusion started); Cycle 1: D15 (predose, 1 h, 2 h, 4 h, and 8 h after infusion started) | Percent change=\[(β-catenin level postdose-predose level)/(predose β-catenin levels)\]\*100. Participants in Cohort 1 had β-catenin samples collected on Cycle 1: D1, D8, and D15, and Cycles 2 through 9: D1. Participants in Cohort 2 had β-catenin samples collected on Cycle 1: D1, D5, and D9 and Cycles 2 through 9: D1. Participants in Cohort 3 had β-catenin samples collected on Cycle 1: D1, D5, D9, and D12 and Cycles 2 through 9: D1. |
| Secondary | Number of Participants Who Died | Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)] | The number of participants who died while on study treatment and the number of participants who died during the 30-day follow-up (30 days post last dose) are reported. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)] | Participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Best Response of Complete Response or Partial Response | Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles) | Participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Best Response of Complete Response or Partial Response | Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles) | Participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to 8 Hours (h) Postdose [AUC(0-8)] | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] | Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis. | nanograms*hours per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: AUC From Time 0 to Infinity [AUC(0-inf)] | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] | Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | PK: Maximum Concentration (Cmax) | Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)] | Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Percent Change From Predose Beta (β)-Catenin Levels | Cycle 1: D1 and D9 (predose, 1 h, 2 h, 4 h, 8 h, and 24 h after infusion started); Cycle 1: D5, D8, and D12 and C2 through C9: D1 (predose, 2 h after infusion started); Cycle 1: D15 (predose, 1 h, 2 h, 4 h, and 8 h after infusion started) | Participants who received at least 1 dose of study drug and had a predose and at least 1 postdose β-catenin sample collected. | percent change | MEAN |
| SECONDARY | Number of Participants Who Died | Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)] | Participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Cohort 1, 40 mg LY2090314: D1, D8, D15 | Study Drug-Related AE(s) | 6 | Participants | |
| Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Cohort 2, 40 mg LY2090314: D1, D5, D9 | Study Drug-Related AE(s) | 5 | Participants | |
| Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | Study Drug-Related AE(s) | 6 | Participants | |
| Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Cohort 1, 40 mg LY2090314: D1, D8, D15 | Study Drug-Related SAE(s) | 0 | Participants | |
| Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Cohort 2, 40 mg LY2090314: D1, D5, D9 | Study Drug-Related SAE(s) | 2 | Participants | |
| Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | Study Drug-Related SAE(s) | 1 | Participants | |
| Number of Participants With Best Response of Complete Response or Partial Response | Cohort 1, 40 mg LY2090314: D1, D8, D15 | CR | 0 | Participants | |
| Number of Participants With Best Response of Complete Response or Partial Response | Cohort 2, 40 mg LY2090314: D1, D5, D9 | CR | 0 | Participants | |
| Number of Participants With Best Response of Complete Response or Partial Response | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | CR | 0 | Participants | |
| Number of Participants With Best Response of Complete Response or Partial Response | Cohort 1, 40 mg LY2090314: D1, D8, D15 | PR | 0 | Participants |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1, 40 mg LY2090314: D1, D8, D15 | 7 | |
| Overall Study | STARTED | Cohort 2, 40 mg LY2090314: D1, D5, D9 | 6 | |
| Overall Study | STARTED | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | 7 | |
| Overall Study | Received at Least 1 Dose of LY2090314 | Cohort 1, 40 mg LY2090314: D1, D8, D15 | 7 | |
| Overall Study | Received at Least 1 Dose of LY2090314 | Cohort 2, 40 mg LY2090314: D1, D5, D9 | 6 | |
| Overall Study | Received at Least 1 Dose of LY2090314 | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | 7 | |
| Overall Study | COMPLETED | Cohort 1, 40 mg LY2090314: D1, D8, D15 | 2 | |
| Overall Study | COMPLETED | Cohort 2, 40 mg LY2090314: D1, D5, D9 | 5 | |
| Overall Study | COMPLETED | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | 3 | |
| Overall Study | NOT COMPLETED | Cohort 1, 40 mg LY2090314: D1, D8, D15 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events423
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, 40 mg LY2090314: D1, D8, D15 | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2, 40 mg LY2090314: D1, D5, D9 | 2 | 6 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | 1 | 7 | 1 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Cohort 1, 40 mg LY2090314: D1, D8, D15 | 0 | 7 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Cohort 2, 40 mg LY2090314: D1, D5, D9 | 1 | 6 | 1 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | 0 | 7 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1, 40 mg LY2090314: D1, D8, D15 | 2 | 7 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2, 40 mg LY2090314: D1, D5, D9 | 0 | 6 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | 0 | 7 | 0 |
| other | Atrial flutter | Cardiac disorders | Cohort 1, 40 mg LY2090314: D1, D8, D15 | 0 | 7 | 0 |
1 to 10 of 423Source ClinicalTrials.gov
See all 423 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1, 40 mg LY2090314: D1, D8, D15 | ||
| Total, all-cause mortality | Cohort 2, 40 mg LY2090314: D1, D5, D9 | ||
| Total, all-cause mortality | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | ||
| Total, other adverse events | Cohort 1, 40 mg LY2090314: D1, D8, D15 | 7 | 7 |
| Total, other adverse events | Cohort 2, 40 mg LY2090314: D1, D5, D9 | 6 | 6 |
| Total, other adverse events | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | 7 | 7 |
| Total, serious adverse events | Cohort 1, 40 mg LY2090314: D1, D8, D15 | 4 | 7 |
| Total, serious adverse events | Cohort 2, 40 mg LY2090314: D1, D5, D9 | 5 | 6 |
| Total, serious adverse events | Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 | 6 | 7 |
Source ClinicalTrials.gov
Papers0
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01214603
GET https://conductscience.org/api/trials/v1/NCT01214603/results?page=2