A Study for Participants With Small-Cell Lung Cancer
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01025284
Collaborator
(none)
64
11
2
31
5.8
0.2
Study Details
Study Description
Brief Summary
Part A: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.
Part B: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
64 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of LY2523355 in Patients With Extensive-Stage Small-Cell Lung Cancer
Study Start Date
:
Dec 1, 2009
Actual Primary Completion Date
:
Jul 1, 2012
Actual Study Completion Date
:
Jul 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A LY2523355 8 milligrams per square meter (mg/m²) per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, 9 of each 21-day cycle, until disease progression or unacceptable toxicity. |
Drug: LY2523355
Administered intravenously as a 1-hour infusion
|
| Experimental: Part B LY2523355 5 or 6 mg/m² per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, 3 plus granulocyte colony-stimulating factor (G-CSF) support administered subcutaneously beginning on Day 4 of each 21-day cycle, until disease progression or unacceptable toxicity. |
Drug: LY2523355
Administered intravenously as a 1-hour infusion
Drug: Granulocyte colony-stimulating factor (G-CSF)
Administered subcutaneously
|
Outcome Measures
Primary Outcome Measures
- Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate) [Date of enrollment to date of measured progressive disease up to 99.6 weeks]
The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR, then divided by the total number of participants treated, then multiplied by 100.
- Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) [Date of enrollment to date of measured progressive disease up to 18.1 weeks]
Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
Secondary Outcome Measures
- Part A: Progression-Free Survival [Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks]
Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment.
- Part B: Progression-Free Survival [Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeks]
Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment.
- Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) [Date of enrollment to date of measured progressive disease 99.6 weeks]
Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
- Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate) [Date of enrollment to date of measured progressive disease up to 18.1 weeks]
The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated, then multiplied by 100.
- Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307) [Days 1,5 and 9 of Cycle 1 (21-day cycle)]
- Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 [Day 3 of Cycle 1 (21-day cycle)]
- Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] [Days 1,5 and 9 of Cycle 1 (21-day cycle)]
Due to the very limited pharmacokinetic sampling employed in Part A of the study, the AUC(0-∞) of LY2523355 could not be accurately calculated.
- Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] [Day 3 of Cycle 1 (21-day cycle)]
- Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI) [Baseline and follow-up up to 104 weeks after the first dose of study drug]
LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. The LCSS total score was defined as the mean of the 9 items of the scale, with scores range from 0 (for best outcome) to 100 (for worst outcome). ASBI was calculated as the mean of six symptom-specific questions from the LCSS, with scores range from 0 (for best outcome) to 100 (for worst outcome).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have histological or cytological evidence of extensive-disease small-cell lung cancer
-
Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
-
Have received at least 1 prior chemotherapy regimen with agents known to provide clinical benefit for small-cell lung cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy
-
Have discontinued all previous therapies for cancer, including chemotherapy, biologic therapy, hormone therapy, or radiotherapy. Participants must have recovered from the acute effects of therapy (except alopecia and fatigue) before study enrollment
-
Part A: Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group scale
-
Part B: Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale
Exclusion Criteria:
-
Have received treatment within 28 days of the first dose of LY2523355 with a drug that has not received regulatory approval for any indication
-
Have a mixed histological diagnosis of small-cell lung cancer and non-small-cell lung cancer
-
Have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study
-
Part A: Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic participants without history of CNS metastases is not required
-
Part B: Have symptomatic, untreated, or uncontrolled CNS metastases or a history of CNS metastases. Participants who have received prophylactic radiation are not excluded. Screening of asymptomatic participants without history of CNS metastases is 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. | Torrington | Connecticut | United States | 06790 |
| 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. | Athens | Georgia | United States | 30607 |
| 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. | Marietta | Georgia | United States | 30060 |
| 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. | Scarborough | Maine | United States | 04074 |
| 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. | Cherry Hill | New Jersey | United States | 08003 |
| 6 | 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. | Albuquerque | New Mexico | United States | 87131 |
| 7 | 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. | Charleston | South Carolina | United States | 29425 |
| 8 | 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. | Memphis | Tennessee | United States | 38138 |
| 9 | 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. | Seoul | Korea, Republic of | 135-710 | |
| 10 | 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. | Bucharest | Romania | 022328 | |
| 11 | 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. | Cluj-Napoca | Romania | 3400 |
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 9AM-5PM Eastern time(UTC/GMT-5hours, 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:
NCT01025284
Other Study ID Numbers:
- 12253
- I1Y-MC-JFBD
First Posted:
Dec 3, 2009
Last Update Posted:
Sep 17, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | This is a nonrandomized, open-label, 2-part study. |
| Arm/Group Title | Part A - 8 mg/m²/Day | Part B - 5 mg/m²/Day | Part B - 6 mg/m²/Day |
|---|---|---|---|
| Arm/Group Description | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. | 5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. | 6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle. |
| Period Title: Overall Study | |||
| STARTED | 38 | 18 | 8 |
| Received at Least 1 Dose of Study Drug | 38 | 18 | 8 |
| COMPLETED | 38 | 16 | 8 |
| NOT COMPLETED | 0 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Part A - 8 mg/m²/Day | Part B - 5 mg/m²/Day | Part B - 6 mg/m²/Day | Total |
|---|---|---|---|---|
| Arm/Group Description | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. | 5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. | 6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle. | Total of all reporting groups |
| Overall Participants | 38 | 18 | 8 | 64 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
64.88
(6.3)
|
63.33
(8.4)
|
63.40
(9.1)
|
64.26
(7.2)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
11
28.9%
|
3
16.7%
|
2
25%
|
16
25%
|
| Male |
27
71.1%
|
15
83.3%
|
6
75%
|
48
75%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||
| Asian |
12
31.6%
|
5
27.8%
|
4
50%
|
21
32.8%
|
| Black or African American |
1
2.6%
|
0
0%
|
1
12.5%
|
2
3.1%
|
| White |
25
65.8%
|
13
72.2%
|
3
37.5%
|
41
64.1%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
17
44.7%
|
10
55.6%
|
4
50%
|
31
48.4%
|
| Romania |
9
23.7%
|
3
16.7%
|
0
0%
|
12
18.8%
|
| South Korea |
12
31.6%
|
5
27.8%
|
4
50%
|
21
32.8%
|
Outcome Measures
| Title | Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate) |
|---|---|
| Description | The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR, then divided by the total number of participants treated, then multiplied by 100. |
| Time Frame | Date of enrollment to date of measured progressive disease up to 99.6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug in Part A. |
| Arm/Group Title | Part A |
|---|---|
| Arm/Group Description | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. |
| Measure Participants | 38 |
| Number (90% Confidence Interval) [percentage of participants] |
2.6
6.8%
|
| Title | Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) |
|---|---|
| Description | Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100. |
| Time Frame | Date of enrollment to date of measured progressive disease up to 18.1 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug in Part B. |
| Arm/Group Title | Part B |
|---|---|
| Arm/Group Description | 5 or 6 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. |
| Measure Participants | 26 |
| Number (90% Confidence Interval) [percentage of participants] |
26.9
70.8%
|
| Title | Part A: Progression-Free Survival |
|---|---|
| Description | Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment. |
| Time Frame | Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug in Part A. The numbers of participants censored are 4. |
| Arm/Group Title | Part A |
|---|---|
| Arm/Group Description | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. |
| Measure Participants | 38 |
| Median (90% Confidence Interval) [weeks] |
5.3
|
| Title | Part B: Progression-Free Survival |
|---|---|
| Description | Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment. |
| Time Frame | Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug in Part B. The numbers of participants censored are 4. |
| Arm/Group Title | Part B |
|---|---|
| Arm/Group Description | 5 or 6 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. |
| Measure Participants | 26 |
| Median (90% Confidence Interval) [weeks] |
6.1
|
| Title | Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) |
|---|---|
| Description | Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100. |
| Time Frame | Date of enrollment to date of measured progressive disease 99.6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug in Part A. |
| Arm/Group Title | Part A |
|---|---|
| Arm/Group Description | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. |
| Measure Participants | 38 |
| Number (90% Confidence Interval) [percentage of participants] |
23.7
62.4%
|
| Title | Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate) |
|---|---|
| Description | The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated, then multiplied by 100. |
| Time Frame | Date of enrollment to date of measured progressive disease up to 18.1 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug in Part B. |
| Arm/Group Title | Part B |
|---|---|
| Arm/Group Description | 5 or 6 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. |
| Measure Participants | 26 |
| Number (90% Confidence Interval) [percentage of participants] |
0
0%
|
| Title | Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307) |
|---|---|
| Description | |
| Time Frame | Days 1,5 and 9 of Cycle 1 (21-day cycle) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received 1 dose of study drug on Days 1, 5, and 9 of Cycle 1 and had Cmax samples collected on Days 1, 5, and 9 of Cycle 1 in Part A. |
| Arm/Group Title | Part A |
|---|---|
| Arm/Group Description | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. |
| Measure Participants | 37 |
| LY2523355 Day 1 |
146
(69.5)
|
| LY2523355 Day 5 |
157
(91.4)
|
| LY2523355 Day 9 |
100
(420)
|
| Metabolite Day 1 |
7.17
(55.4)
|
| Metabolite Day 5 |
6.29
(50.8)
|
| Metabolite Day 9 |
6.11
(129)
|
| Title | Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 |
|---|---|
| Description | |
| Time Frame | Day 3 of Cycle 1 (21-day cycle) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had Cmax samples collected on Day 3 of Cycle 1 in Part B. |
| Arm/Group Title | Part B - 5 mg/m²/Day | Part B - 6 mg/m²/Day |
|---|---|---|
| Arm/Group Description | 5 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. | 6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle. |
| Measure Participants | 17 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter (ng/mL)] |
128
(82)
|
258
(32)
|
| Title | Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] |
|---|---|
| Description | Due to the very limited pharmacokinetic sampling employed in Part A of the study, the AUC(0-∞) of LY2523355 could not be accurately calculated. |
| Time Frame | Days 1,5 and 9 of Cycle 1 (21-day cycle) |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participants were analyzed due to the very limited pharmacokinetic sampling employed in Part A that did not allow accurate calculation of the AUC(0-∞) on Days 1, 5, and 9 of Cycle 1. |
| Arm/Group Title | Part A |
|---|---|
| Arm/Group Description | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. |
| Measure Participants | 0 |
| Title | Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] |
|---|---|
| Description | |
| Time Frame | Day 3 of Cycle 1 (21-day cycle) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had pharmacokinetic samples collected on Day 3 of Cycle 1 in Part B that enabled calculation of the AUC(0-∞). |
| Arm/Group Title | Part B - 5 mg/m²/Day | Part B - 6 mg/m²/Day |
|---|---|---|
| Arm/Group Description | 5 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. | 6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. |
| Measure Participants | 17 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms*hour/milliliter (ng*h/mL)] |
639
(41)
|
1220
(38)
|
| Title | Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI) |
|---|---|
| Description | LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. The LCSS total score was defined as the mean of the 9 items of the scale, with scores range from 0 (for best outcome) to 100 (for worst outcome). ASBI was calculated as the mean of six symptom-specific questions from the LCSS, with scores range from 0 (for best outcome) to 100 (for worst outcome). |
| Time Frame | Baseline and follow-up up to 104 weeks after the first dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug and had total LCSS and ASBI scores at baseline and follow-up in Part B. |
| Arm/Group Title | Part B |
|---|---|
| Arm/Group Description | 5 or 6 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. |
| Measure Participants | 24 |
| Total LCSS at Baseline |
28.24
(15.2)
|
| Total LCSS at Follow-up |
42.61
(14.5)
|
| ASBI at Baseline |
26.76
(14.1)
|
| ASBI at Follow-up |
36.41
(11.1)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Part A - 8 mg/m²/Day | Part B - 5 mg/m²/Day | Part B - 6 mg/m²/Day | |||
| Arm/Group Description | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. | 5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. | 6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle. | |||
All Cause Mortality |
||||||
| Part A - 8 mg/m²/Day | Part B - 5 mg/m²/Day | Part B - 6 mg/m²/Day | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Part A - 8 mg/m²/Day | Part B - 5 mg/m²/Day | Part B - 6 mg/m²/Day | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/38 (21.1%) | 8/18 (44.4%) | 8/8 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Febrile neutropenia | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Neutropenia | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 1 |
| Cardiac disorders | ||||||
| Atrial fibrillation | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Coronary artery disease | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Vomiting | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| General disorders | ||||||
| Asthenia | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Chest pain | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Mucosal inflammation | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 4/8 (50%) | 4 |
| Infections and infestations | ||||||
| Atypical pneumonia | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Pneumonia | 3/38 (7.9%) | 3 | 0/18 (0%) | 0 | 2/8 (25%) | 3 |
| Sepsis | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Ankle fracture | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Road traffic accident | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Subdural haematoma | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Dehydration | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Flank pain | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Muscular weakness | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Nervous system disorders | ||||||
| Headache | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Spinal cord compression | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Psychiatric disorders | ||||||
| Confusional state | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Mental status changes | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Aspiration | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Chronic obstructive pulmonary disease | 0/38 (0%) | 0 | 2/18 (11.1%) | 2 | 0/8 (0%) | 0 |
| Dyspnoea | 2/38 (5.3%) | 2 | 0/18 (0%) | 0 | 3/8 (37.5%) | 3 |
| Haemoptysis | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Hypoxia | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Pleural effusion | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Stevens-johnson syndrome | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Part A - 8 mg/m²/Day | Part B - 5 mg/m²/Day | Part B - 6 mg/m²/Day | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 35/38 (92.1%) | 18/18 (100%) | 7/8 (87.5%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 9/38 (23.7%) | 9 | 3/18 (16.7%) | 3 | 2/8 (25%) | 4 |
| Febrile neutropenia | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Leukopenia | 5/38 (13.2%) | 6 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Lymphopenia | 2/38 (5.3%) | 2 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Neutropenia | 29/38 (76.3%) | 74 | 11/18 (61.1%) | 17 | 3/8 (37.5%) | 5 |
| Thrombocytopenia | 2/38 (5.3%) | 3 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 1 |
| Cardiac disorders | ||||||
| Atrial fibrillation | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Atrial tachycardia | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Sinus tachycardia | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Tachycardia | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 1 |
| Ear and labyrinth disorders | ||||||
| Tinnitus | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Eye disorders | ||||||
| Dry eye | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Vision blurred | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 2/8 (25%) | 2 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 4/38 (10.5%) | 4 | 2/18 (11.1%) | 2 | 0/8 (0%) | 0 |
| Abdominal pain upper | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Constipation | 6/38 (15.8%) | 6 | 4/18 (22.2%) | 6 | 3/8 (37.5%) | 6 |
| Diarrhoea | 7/38 (18.4%) | 9 | 1/18 (5.6%) | 1 | 2/8 (25%) | 2 |
| Dry mouth | 0/38 (0%) | 0 | 2/18 (11.1%) | 2 | 0/8 (0%) | 0 |
| Dysphagia | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 1 |
| Gastrooesophageal reflux disease | 2/38 (5.3%) | 2 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Glossodynia | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Nausea | 8/38 (21.1%) | 8 | 2/18 (11.1%) | 2 | 3/8 (37.5%) | 4 |
| Oral pain | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 2/8 (25%) | 2 |
| Stomatitis | 1/38 (2.6%) | 1 | 4/18 (22.2%) | 4 | 0/8 (0%) | 0 |
| Vomiting | 3/38 (7.9%) | 5 | 3/18 (16.7%) | 4 | 1/8 (12.5%) | 3 |
| General disorders | ||||||
| Asthenia | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 2/8 (25%) | 2 |
| Chest discomfort | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Chest pain | 2/38 (5.3%) | 2 | 1/18 (5.6%) | 2 | 2/8 (25%) | 2 |
| Fatigue | 10/38 (26.3%) | 12 | 7/18 (38.9%) | 9 | 4/8 (50%) | 4 |
| Gait disturbance | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Mucosal inflammation | 0/38 (0%) | 0 | 2/18 (11.1%) | 7 | 2/8 (25%) | 3 |
| Non-cardiac chest pain | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Oedema peripheral | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Immune system disorders | ||||||
| Drug hypersensitivity | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Infections and infestations | ||||||
| Fungal skin infection | 0/38 (0%) | 0 | 1/18 (5.6%) | 2 | 0/8 (0%) | 0 |
| Skin infection | 0/38 (0%) | 0 | 2/18 (11.1%) | 2 | 0/8 (0%) | 0 |
| Urinary tract infection | 2/38 (5.3%) | 2 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Fall | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Investigations | ||||||
| Alanine aminotransferase increased | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 1 |
| Aspartate aminotransferase increased | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 1 |
| Blood alkaline phosphatase increased | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 1 |
| Blood bilirubin increased | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Blood creatine increased | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Blood creatinine increased | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Blood lactate dehydrogenase increased | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Neutrophil count decreased | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Platelet count decreased | 1/38 (2.6%) | 1 | 2/18 (11.1%) | 2 | 0/8 (0%) | 0 |
| Weight decreased | 0/38 (0%) | 0 | 2/18 (11.1%) | 2 | 2/8 (25%) | 2 |
| White blood cell count decreased | 0/38 (0%) | 0 | 3/18 (16.7%) | 3 | 0/8 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 8/38 (21.1%) | 8 | 4/18 (22.2%) | 4 | 3/8 (37.5%) | 4 |
| Dehydration | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 2 |
| Hyperglycaemia | 1/38 (2.6%) | 1 | 2/18 (11.1%) | 3 | 1/8 (12.5%) | 3 |
| Hyperkalaemia | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 2/8 (25%) | 2 |
| Hypoalbuminaemia | 0/38 (0%) | 0 | 2/18 (11.1%) | 2 | 0/8 (0%) | 0 |
| Hypocalcaemia | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Hypokalaemia | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 1 |
| Hypomagnesaemia | 2/38 (5.3%) | 2 | 1/18 (5.6%) | 1 | 2/8 (25%) | 2 |
| Hyponatraemia | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/38 (2.6%) | 1 | 2/18 (11.1%) | 2 | 0/8 (0%) | 0 |
| Back pain | 2/38 (5.3%) | 2 | 2/18 (11.1%) | 2 | 1/8 (12.5%) | 1 |
| Bone pain | 3/38 (7.9%) | 4 | 2/18 (11.1%) | 2 | 1/8 (12.5%) | 1 |
| Muscle spasms | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Muscular weakness | 2/38 (5.3%) | 2 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Musculoskeletal chest pain | 0/38 (0%) | 0 | 2/18 (11.1%) | 2 | 0/8 (0%) | 0 |
| Musculoskeletal pain | 2/38 (5.3%) | 2 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Myalgia | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Neck pain | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 1 |
| Nervous system disorders | ||||||
| Dizziness | 4/38 (10.5%) | 5 | 3/18 (16.7%) | 4 | 1/8 (12.5%) | 1 |
| Dysgeusia | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Headache | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 1/8 (12.5%) | 2 |
| Neuropathy peripheral | 2/38 (5.3%) | 2 | 2/18 (11.1%) | 2 | 0/8 (0%) | 0 |
| Presyncope | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Syncope | 2/38 (5.3%) | 3 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Psychiatric disorders | ||||||
| Agitation | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Anxiety | 2/38 (5.3%) | 3 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Confusional state | 5/38 (13.2%) | 5 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Depression | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Insomnia | 4/38 (10.5%) | 4 | 0/18 (0%) | 0 | 2/8 (25%) | 2 |
| Sleep disorder | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Dysuria | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 2 |
| Micturition disorder | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 8/38 (21.1%) | 9 | 2/18 (11.1%) | 2 | 0/8 (0%) | 0 |
| Dysphonia | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Dyspnoea | 6/38 (15.8%) | 6 | 2/18 (11.1%) | 2 | 2/8 (25%) | 2 |
| Haemoptysis | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 1/8 (12.5%) | 1 |
| Hypoxia | 2/38 (5.3%) | 2 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Nasal congestion | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Oropharyngeal pain | 1/38 (2.6%) | 1 | 1/18 (5.6%) | 1 | 2/8 (25%) | 2 |
| Pneumonitis | 2/38 (5.3%) | 2 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Productive cough | 1/38 (2.6%) | 1 | 0/18 (0%) | 0 | 2/8 (25%) | 2 |
| Wheezing | 2/38 (5.3%) | 2 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Alopecia | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Blister | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Hyperhidrosis | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
| Pruritus | 7/38 (18.4%) | 8 | 0/18 (0%) | 0 | 0/8 (0%) | 0 |
| Rash | 3/38 (7.9%) | 3 | 2/18 (11.1%) | 2 | 2/8 (25%) | 2 |
| Skin discolouration | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Sunburn | 0/38 (0%) | 0 | 1/18 (5.6%) | 1 | 0/8 (0%) | 0 |
| Vascular disorders | ||||||
| Hypotension | 2/38 (5.3%) | 2 | 3/18 (16.7%) | 3 | 2/8 (25%) | 2 |
| Orthostatic hypotension | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 2 |
| Superior vena cava syndrome | 0/38 (0%) | 0 | 0/18 (0%) | 0 | 1/8 (12.5%) | 1 |
Limitations/Caveats
[Not Specified]
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:
NCT01025284
Other Study ID Numbers:
- 12253
- I1Y-MC-JFBD
First Posted:
Dec 3, 2009
Last Update Posted:
Sep 17, 2019
Last Verified:
Sep 1, 2019