A Study for Patients With Acute Leukemia
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT01214655
Collaborator
(none)
33
5
2
32
6.6
0.2
Study Details
Study Description
Brief Summary
This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355 that can be safely administered to participants with acute leukemia. Part A and Part B are dose escalation of two schedules in participants with acute leukemia. Parts A and B will enroll concurrently. Part C is a dose expansion for each schedule in participants with acute myeloblastic leukemia (AML).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
33 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1 Study of LY2523355 in Patients With Acute Leukemia
Study Start Date
:
Jun 1, 2008
Actual Primary Completion Date
:
Feb 1, 2011
Actual Study Completion Date
:
Feb 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY2523355 on Days 1, 2, and 3 Starting dose was 2 milligrams per meter squared (mg/m^2) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle. |
Drug: LY2523355
Administered as a 1-hour IV infusion for at least 2 cycles. Cycle length is 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
|
| Experimental: LY2523355 on Days 1, 5, and 9 Starting dose was 8 milligrams per meter squared (mg/m^2) administered by a 1-hour IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle. |
Drug: LY2523355
Administered as a 1-hour IV infusion for at least 2 cycles. Cycle length is 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Dose escalation period for both schedules:
-
Participants must have a confirmed diagnosis of acute leukemia regardless of sub-type and for whom experimental Phase 1 therapy is appropriate.
-
Are greater than or equal to 18 years of age.
-
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
-
Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.
Dose confirmation period for both schedules:
-
Participant must have a confirmed diagnosis of untreated acute myeloblastic leukemia (AML), should not be a candidate for standard therapy, and a clinical trial is a preferred treatment option or have acute AML that is relapsed or refractory to no more than 2 prior induction regimens. Hydroxyurea to control prior blast counts is not considered a prior regimen.
-
Are greater than or equal to 60 years of age.
-
Have a performance status of 0 or 1 on the ECOG scale.
-
Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.
Exclusion Criteria:
-
Have received treatment within 28 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
-
Participants with known central nervous system (CNS) leukemia by spinal fluid cytology or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Participants with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment.
-
Have other active malignancy (with the exception of basal and squamous cell skin cancer) at time of study entry.
-
Have had an autologous or allogenic bone marrow transplant within 3 months. All organ toxicity must be resolved.
-
Have evidence of graft-versus-host disease due to an allogenic bone marrow transplant.
-
Have uncontrolled systemic infection.
-
Females who are pregnant or lactating.
-
Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening not required).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chicago | Illinois | United States | |
| 2 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis | Indiana | United States | |
| 3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Boston | Massachusetts | United States | |
| 4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nashville | Tennessee | United States | |
| 5 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | United States |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01214655
Other Study ID Numbers:
- 12119
- I1Y-MC-JFBC
First Posted:
Oct 5, 2010
Last Update Posted:
May 13, 2019
Last Verified:
Sep 1, 2017
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A participant was considered to have completed the trial if they received at 2 cycles of treatment. Participant Flow Arms represent schedule of dosing, with dose escalation, dose levels and participants who joined the dose level presented as Milestones. Study was based on best Schedule of dosing, not dose levels. |
| Arm/Group Title | Schedule A LY2523355 | Schedule B LY2523355 | Schedule C LY2523355 |
|---|---|---|---|
| Arm/Group Description | Participants received a dose escalation to maximum tolerated dose (MTD) from 2 mg/m²/day to 4,5 and 6 mg/m²/day during a 1 hour (hr) infusion on Days 1,2, 3 (Schedule A) of a 21 day cycle. Participants did not have to escalate doses and participants could join at a higher dose level. | Participants received a dose escalation to maximum tolerated dose (MTD) ranging from 8 mg/m²/day (starting dose) to 10,12 and 14 mg/m²/day during a 1 hour (hr) infusion on Days 1,5, 9 (Schedule B)of a 21 day cycle Participants did not have to escalate doses and participants could join at a higher dose level. | Starting dose was 5 mg/m²/day administered by IV infusion over 1 hour on Days 1, 2, and 3 (Schedule C) of every 21-day Cycle. |
| Period Title: Part A | |||
| STARTED | 10 | 0 | 0 |
| Received 2 mg Study Drug | 3 | 0 | 0 |
| Escalated From 2 to 4 mg/m²/Day | 3 | 0 | 0 |
| Joined 4 mg Group | 1 | 0 | 0 |
| Escalated From 4 mg Study Drug | 0 | 0 | 0 |
| Joined 5 mg Study Drug | 2 | 0 | 0 |
| Escalated From 5 mg Study Drug | 1 | 0 | 0 |
| Joined 6 mg Group | 4 | 0 | 0 |
| Received 6 mg Study Drug | 5 | 0 | 0 |
| COMPLETED | 2 | 0 | 0 |
| NOT COMPLETED | 8 | 0 | 0 |
| Period Title: Part A | |||
| STARTED | 0 | 15 | 0 |
| Received at Least 1 Dose of Study Drug | 0 | 15 | 0 |
| Recieved 8 mg/m²/Day Study Drug | 0 | 4 | 0 |
| Escalated From 8 to 10 mg/m²/Day | 0 | 2 | 0 |
| Joined 10 mg/m²/Day Study D | 0 | 3 | 0 |
| Escalated to 12 mg/m²/Day | 0 | 2 | 0 |
| Joined 12 mg/m²/Day | 0 | 5 | 0 |
| Escalated From 12 to 14 mg/m²/Day | 0 | 1 | 0 |
| Joined 14 mg/m²/Day | 0 | 3 | 0 |
| COMPLETED | 0 | 2 | 0 |
| NOT COMPLETED | 0 | 13 | 0 |
| Period Title: Part A | |||
| STARTED | 0 | 0 | 8 |
| Received at Least 1 Dose of 5 mg/m²/Day | 0 | 0 | 8 |
| COMPLETED | 0 | 0 | 1 |
| NOT COMPLETED | 0 | 0 | 7 |
Baseline Characteristics
| Arm/Group Title | Schedule A LY2523355 | Schedule B LY2523355 | Schedule C LY2523355 | Total |
|---|---|---|---|---|
| Arm/Group Description | Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by intravenous (IV) infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle. | Starting dose was 8 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle. | Starting dose was 5 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle. No participants in Part C escalated from their initial dose. | Total of all reporting groups |
| Overall Participants | 10 | 15 | 8 | 33 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
63.2
(19.43)
|
65.3
(12.98)
|
70.7
(5.75)
|
66.0
(13.98)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
6
60%
|
3
20%
|
5
62.5%
|
14
42.4%
|
| Male |
4
40%
|
12
80%
|
3
37.5%
|
19
57.6%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Caucasian |
7
70%
|
14
93.3%
|
7
87.5%
|
28
84.8%
|
| African |
2
20%
|
0
0%
|
1
12.5%
|
3
9.1%
|
| Hispanic |
0
0%
|
1
6.7%
|
0
0%
|
1
3%
|
| Native American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| East Asian |
1
10%
|
0
0%
|
0
0%
|
1
3%
|
| West Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
10
100%
|
15
100%
|
8
100%
|
33
100%
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants) | ||||
| ECOG Status 0 |
6
60%
|
2
13.3%
|
1
12.5%
|
9
27.3%
|
| ECOG Status 1 |
4
40%
|
7
46.7%
|
6
75%
|
17
51.5%
|
| ECOG Status 2 |
0
0%
|
6
40%
|
1
12.5%
|
7
21.2%
|
Outcome Measures
| Title | Recommended Dose and Schedule for Phase 2 Studies in Acute Leukemia |
|---|---|
| Description | 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. |
| Time Frame | Baseline up to the end of Cycle 2 (Day 42) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least one dose of study medication (LY2523355). |
| Arm/Group Title | LY2523355 |
|---|---|
| Arm/Group Description | Escalating doses starting at 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study. |
| Measure Participants | 33 |
| Number [mg/m^2/day; Days 1, 2, and 3] |
5
|
| Title | Number of Participants With Clinically Significant Effects |
|---|---|
| Description | 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. |
| Time Frame | Baseline up to study completion (up to 213 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least one dose of study medication (LY2523355). |
| Arm/Group Title | Schedule A LY2523355 | Schedule B LY2523355 | Schedule C LY2523355 |
|---|---|---|---|
| Arm/Group Description | Escalating doses starting at 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. | Starting dose was 8 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle. | Starting dose was 5 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle. |
| Measure Participants | 10 | 15 | 8 |
| Count of Participants [Participants] |
7
70%
|
9
60%
|
4
50%
|
| Title | Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Schedule A 2 mg LY2523355 | Schedule A 4 mg LY2524455 | Schedule A,C 5 mg LY2523355 | Schedule A 6 mg LY2523355 | Schedule B 8 mg LY2523355 | Schedule B 10 mg LY2523355 | Schedule B 12 mg LY2523355 | Schedule B 14 mg 2523355 | Schedule B 16 mg LY2523355 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle. | 4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle. | Schedule A 5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A and Part C combined. | 6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle. | 8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle. | 10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle. | 12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle. | 14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle. | 16 mg/m²/day was inadvertently given to a participant. |
| Measure Participants | 3 | 1 | 7 | 6 | 5 | 3 | 4 | 2 | 1 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter (ng/mL)] |
198
(1410)
|
895
(NA)
|
240
(420)
|
391
(254)
|
169
(47)
|
354
(66)
|
254
(18)
|
NA
(NA)
|
17,000
(NA)
|
| Title | Pharmacokinetics, Maximum Plasma Concentration (Cmax), Multiple Dose |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received more than one dose of LY2523355 with evaluable pharmacokinetic data, Schedules A,B,C. |
| Arm/Group Title | Schedule A Day 3 2 mg LY2523355 | Schedule A Day 3 4 mg LY2523355 | Schedule A/C Day 3 5 mg LY2523355 | Schedule A Day 3 6 mg LY2523355 | Schedule B Day 9 8 mg LY2523355 | Schedule B Day 9 10 mg LY2523355 | Schedule B Day 9 12 mg LY2523355 | Schedule B Day 9 14 mg LY2523355 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle | 4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle | 5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle. | 6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle. | 8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle | 10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle | 12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A, Part B and Part C. | 14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle |
| Measure Participants | 3 | 1 | 9 | 5 | 3 | 3 | 2 | 1 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter (ng/mL)] |
43.1
(46)
|
2440
(NA)
|
439
(391)
|
187
(69)
|
155
(139)
|
283
(23)
|
NA
(NA)
|
892
(NA)
|
| Title | Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC), Single Dose |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Schedule A Day 1 2 mg LY2523355 | Schedule A Day 1 4 mg LY2524455 | Schedule A,C Day 1 5 mg LY2523355 | Schedule A Day 1 6 mg LY2523355 | Schedule B Day 1 8 mg LY2523355 | Schedule B Day 1 10 mg LY2523355 | Schedule B Day 1 12 mg LY2523355 | Schedule B Day 1 14 mg 2523355 | Schedule B Day 1 16 mg LY2523355 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle | 4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle | 5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A and Part C combined. | 6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle | 8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle. | 10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle. | 12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle. | 14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle. | 16 mg/m²/day was inadvertently given to a participant. |
| Measure Participants | 3 | 1 | 9 | 5 | 3 | 3 | 2 | 2 | 1 |
| The AUC(0-24) |
278
(209)
|
3420
(NA)
|
473
(163)
|
613
(92)
|
469
(22)
|
1060
(31)
|
746
(46)
|
NA
(NA)
|
8770
(NA)
|
| The AUC(0-inf) |
229
(191)
|
3490
(NA)
|
537
(157)
|
675
(86)
|
608
(28)
|
1530
(29)
|
970
(55)
|
NA
(NA)
|
9200
(NA)
|
| Title | Pharmacokinetics, Area Under the Concentration Versus Time (AUC), Multiple Dose |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received more than one dose of LY2523355 with evaluable pharmacokinetic data on Cycle 1 Day 3 or Day 9, schedule dependent. |
| Arm/Group Title | Schedule A Day 3 2 mg LY2523355 | Schedule A Day 3 4 mg LY2523355 | Schedule A/C Day 3 5 mg LY2523355 | Schedule A Day 3 6 mg LY2523355 | Schedule B Day 9 8 mg LY2523355 | Schedule B Day 9 10 mg LY2523355 | Schedule B Day 9 12 mg LY2523355 | Schedule B Day 9 14 mg LY2523355 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle | 4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle | 5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle. | 6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle. | 8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle | 10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle | 12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A, Part B and Part C. | 14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle |
| Measure Participants | 3 | 1 | 9 | 6 | 3 | 3 | 2 | 1 |
| AUC(0-24) |
134
(38)
|
2540
(NA)
|
696
(126)
|
624
(66)
|
623
(81)
|
844
(14)
|
NA
(NA)
|
2910
(NA)
|
| AUC(0-inf), |
187
(45)
|
3120
(NA)
|
992
(117)
|
990
(107)
|
834
(98)
|
1050
(8)
|
NA
(NA)
|
4120
(NA)
|
| Title | Percentage of Participants With a Response for Acute Myelogenous Leukemia Using The Revised International Working Group Criteria |
|---|---|
| Description | 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. |
| Time Frame | Baseline up to disease progression or discontinuation (up to 213 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with acute myelogenous leukemia who received at least one dose of study medication (LY2523355). |
| Arm/Group Title | Schedule A LY2523355 Days 1, 2, and 3 | Schedule B LY2523355 Days 1, 5, and 9 | Schedule C LY2523355 Days 1, 2, and 3 |
|---|---|---|---|
| Arm/Group Description | Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle. Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day). | Starting dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. Five of the 15 participants enrolled in Part B escalated from their initial dose after the first cycle (2 participants escalated from 8 to 10 mg/m^2/day, 1 participant escalated from 8 to 12 mg/m^2/day, 1 participant escalated from 10 to 12 mg/m^2/day, and 1 participant escalated from 12 to 14 mg/m^2/day). | Starting dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. No participants in Part C escalated from their initial dose. |
| Measure Participants | 5 | 9 | 8 |
| Number [percentage of responders] |
0.0
|
11.1
|
12.5
|
| Title | Response Rates for Chronic Myelogenous Leukemia in Blast Crisis (Complete Hematologic Response, no Evidence of Leukemia, Return to Chronic Phase) |
|---|---|
| Description | 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. |
| Time Frame | Baseline up to disease progression or discontinuation (up to 213 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with chronic myelogenous leukemia in blast crisis who received at least one dose of study medication (LY2523355). |
| Arm/Group Title | Schedule A LY2523355 Days 1, 2, and 3 | Schedule B LY2523355 Days 1, 5, and 9 | Schedule C LY2523355 Days 1, 2, and 3 |
|---|---|---|---|
| Arm/Group Description | Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day Cycle. Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day). | Starting dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. Five of the 15 participants enrolled in Part B escalated from their initial dose after the first cycle (2 participants escalated from 8 to 10 mg/m^2/day, 1 participant escalated from 8 to 12 mg/m^2/day, 1 participant escalated from 10 to 12 mg/m^2/day, and 1 participant escalated from 12 to 14 mg/m^2/day). | Starting dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. No participants in Part C escalated from their initial dose. |
| Measure Participants | 0 | 1 | 0 |
| Number [percentage of responders] |
0
|
| Title | Response Rate (Percentage) for Acute Lymphoblastic Leukemia Using The Revised International Working Group Criteria |
|---|---|
| Description | 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. |
| Time Frame | Baseline up to disease progression or discontinuation (up to 213 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with acute lymphoblastic leukemia who received at least one dose of study medication (LY2523355). |
| Arm/Group Title | Schedule A LY2523355 Days 1, 2, and 3 | Schedule B LY2523355 Days 1, 5, and 9 | Schedule C LY2523355 Days 1, 2, and 3 |
|---|---|---|---|
| Arm/Group Description | Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day Cycle. Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day). | Starting dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. Five of the 15 participants enrolled in Part B escalated from their initial dose after the first cycle (2 participants escalated from 8 to 10 mg/m^2/day, 1 participant escalated from 8 to 12 mg/m^2/day, 1 participant escalated from 10 to 12 mg/m^2/day, and 1 participant escalated from 12 to 14 mg/m^2/day). | Starting dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. No participants in Part C escalated from their initial dose. |
| Measure Participants | 4 | 0 | 0 |
| Number [percentage of responders] |
25.0
|
| Title | Death of Participants on Study up to the Follow-up Period |
|---|---|
| Description | 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. |
| Time Frame | Baseline up to end of treatment follow-up (up to 213 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least one dose of study medication (LY2523355). |
| Arm/Group Title | Schedule LY2523355 Days 1, 2, and 3 | Schedule B LY2523355 Days 1, 5, and 9 | Schedule C LY2523355 Days 1, 2, and 3 |
|---|---|---|---|
| Arm/Group Description | Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day Cycle. Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day). | Starting dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. Five of the 15 participants enrolled in Part B escalated from their initial dose after the first cycle (2 participants escalated from 8 to 10 mg/m^2/day, 1 participant escalated from 8 to 12 mg/m^2/day, 1 participant escalated from 10 to 12 mg/m^2/day, and 1 participant escalated from 12 to 14 mg/m^2/day). | Starting dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. No participants in Part C escalated from their initial dose. |
| Measure Participants | 10 | 15 | 8 |
| Count of Participants [Participants] |
1
10%
|
4
26.7%
|
0
0%
|
Adverse Events
| Time Frame | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns. | |||||||||||||||||
| Arm/Group Title | Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3 | Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9 | Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | |||||||||
| Arm/Group Description | Dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle. | Dose was 4 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle. | Dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle. | Dose was 6 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle. | Dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. | Dose was 10 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. | Dose was 12 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. | Dose was 14 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle. | Dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle. | |||||||||
All Cause Mortality |
||||||||||||||||||
| Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3 | Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9 | Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3 | Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9 | Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/3 (33.3%) | 3/4 (75%) | 1/2 (50%) | 3/5 (60%) | 2/4 (50%) | 1/5 (20%) | 3/7 (42.9%) | 3/4 (75%) | 4/8 (50%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| Anaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Febrile neutropenia | 0/3 (0%) | 0 | 2/4 (50%) | 2 | 1/2 (50%) | 1 | 2/5 (40%) | 2 | 1/4 (25%) | 1 | 1/5 (20%) | 1 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 2/8 (25%) | 5 |
| Cardiac disorders | ||||||||||||||||||
| Cardiac failure congestive | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||
| Diarrhoea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 1/8 (12.5%) | 1 |
| Oesophagitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Pancreatitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Stomatitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| General disorders | ||||||||||||||||||
| Mucosal inflammation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 1/4 (25%) | 1 | 1/8 (12.5%) | 1 |
| Pyrexia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||
| Bacteraemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 1/8 (12.5%) | 1 |
| Pneumonia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 1/8 (12.5%) | 1 |
| Sepsis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/4 (25%) | 1 | 1/8 (12.5%) | 1 |
| Metabolism and nutrition disorders | ||||||||||||||||||
| Dehydration | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/4 (25%) | 1 | 0/8 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Pharyngeal haemorrhage | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/4 (25%) | 1 | 0/8 (0%) | 0 |
| Vascular disorders | ||||||||||||||||||
| Deep vein thrombosis | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3 | Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9 | Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9 | Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3 | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 3/4 (75%) | 2/2 (100%) | 5/5 (100%) | 3/4 (75%) | 5/5 (100%) | 7/7 (100%) | 4/4 (100%) | 8/8 (100%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| Anaemia | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/2 (50%) | 1 | 3/5 (60%) | 3 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 1/4 (25%) | 1 | 3/8 (37.5%) | 3 |
| Febrile neutropenia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/4 (25%) | 1 | 0/8 (0%) | 0 |
| Leukocytosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 2/7 (28.6%) | 2 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Leukopenia | 1/3 (33.3%) | 1 | 3/4 (75%) | 3 | 0/2 (0%) | 0 | 2/5 (40%) | 2 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Neutropenia | 1/3 (33.3%) | 1 | 2/4 (50%) | 2 | 1/2 (50%) | 1 | 1/5 (20%) | 1 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 3/7 (42.9%) | 3 | 0/4 (0%) | 0 | 2/8 (25%) | 2 |
| Thrombocytopenia | 2/3 (66.7%) | 2 | 2/4 (50%) | 2 | 1/2 (50%) | 1 | 2/5 (40%) | 2 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/7 (14.3%) | 1 | 1/4 (25%) | 1 | 2/8 (25%) | 2 |
| Cardiac disorders | ||||||||||||||||||
| Atrial fibrillation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 1/8 (12.5%) | 1 |
| Pericardial effusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Tachycardia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 2/5 (40%) | 2 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 1/4 (25%) | 1 | 1/8 (12.5%) | 1 |
| Eye disorders | ||||||||||||||||||
| Vision blurred | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 2/7 (28.6%) | 2 | 2/4 (50%) | 2 | 0/8 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||
| Abdominal pain upper | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Constipation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 2/7 (28.6%) | 2 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Diarrhoea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 2 | 2/5 (40%) | 2 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 4/7 (57.1%) | 4 | 2/4 (50%) | 2 | 0/8 (0%) | 0 |
| Haemorrhoids | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 1/4 (25%) | 1 | 0/8 (0%) | 0 |
| Nausea | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/2 (50%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 2/5 (40%) | 2 | 2/7 (28.6%) | 2 | 2/4 (50%) | 2 | 3/8 (37.5%) | 4 |
| Oral pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/4 (25%) | 1 | 1/8 (12.5%) | 1 |
| Proctalgia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Stomatitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 1/4 (25%) | 1 | 2/8 (25%) | 2 |
| Vomiting | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/2 (50%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 1/4 (25%) | 1 | 2/8 (25%) | 2 |
| General disorders | ||||||||||||||||||
| Asthenia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 1/8 (12.5%) | 1 |
| Chills | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/4 (25%) | 1 | 1/8 (12.5%) | 1 |
| Fatigue | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 2/4 (50%) | 2 | 3/8 (37.5%) | 3 |
| Mucosal inflammation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 1/4 (25%) | 1 | 2/5 (40%) | 2 | 1/7 (14.3%) | 1 | 1/4 (25%) | 1 | 3/8 (37.5%) | 3 |
| Oedema peripheral | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 2/5 (40%) | 2 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Pyrexia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 2/7 (28.6%) | 2 | 3/4 (75%) | 3 | 4/8 (50%) | 7 |
| Infections and infestations | ||||||||||||||||||
| Anal abscess | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Contusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 2/8 (25%) | 2 |
| Investigations | ||||||||||||||||||
| Haemoglobin decreased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 3/5 (60%) | 3 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Platelet count decreased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||
| Decreased appetite | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 2/4 (50%) | 2 | 2/5 (40%) | 2 | 1/7 (14.3%) | 1 | 2/4 (50%) | 2 | 3/8 (37.5%) | 3 |
| Hyperglycaemia | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/2 (0%) | 0 | 2/5 (40%) | 2 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Hyperuricaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 | 1/5 (20%) | 1 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Hypokalaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Hypomagnesaemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 1/8 (12.5%) | 1 |
| Hypophosphataemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 1/8 (12.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Arthralgia | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Pain in extremity | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 2/8 (25%) | 2 |
| Nervous system disorders | ||||||||||||||||||
| Dizziness | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 1/8 (12.5%) | 1 |
| Psychiatric disorders | ||||||||||||||||||
| Anxiety | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 1/4 (25%) | 1 | 0/8 (0%) | 0 |
| Insomnia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 2/7 (28.6%) | 2 | 2/4 (50%) | 2 | 0/8 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Cough | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 2/5 (40%) | 2 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 2/4 (50%) | 2 | 1/8 (12.5%) | 1 |
| Dyspnoea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 2/5 (40%) | 2 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/7 (14.3%) | 1 | 2/4 (50%) | 2 | 2/8 (25%) | 2 |
| Epistaxis | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 2/4 (50%) | 2 | 1/8 (12.5%) | 1 |
| Oropharyngeal pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 1/4 (25%) | 1 | 1/8 (12.5%) | 1 |
| Wheezing | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/4 (25%) | 1 | 1/8 (12.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| Alopecia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 2/8 (25%) | 2 |
| Blister | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Ecchymosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 2/5 (40%) | 2 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/4 (0%) | 0 | 0/8 (0%) | 0 |
| Hyperhidrosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 2/4 (50%) | 2 | 2/8 (25%) | 3 |
| Rash | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/4 (0%) | 0 | 1/8 (12.5%) | 2 |
Limitations/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.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01214655
Other Study ID Numbers:
- 12119
- I1Y-MC-JFBC
First Posted:
Oct 5, 2010
Last Update Posted:
May 13, 2019
Last Verified:
Sep 1, 2017