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A Study for Participants With Small-Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01025284
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Small Cell Lung Cancer
Interventions: Drug: LY2523355
Drug: Granulocyte colony-stimulating factor (G-CSF)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is a nonrandomized, open-label, 2-part study.

Reporting Groups
  Description
Part A - 8 mg/m²/Day 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.
Part B - 5 mg/m²/Day 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.
Part B - 6 mg/m²/Day 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.

Participant Flow:   Overall Study
    Part A - 8 mg/m²/Day   Part B - 5 mg/m²/Day   Part B - 6 mg/m²/Day
STARTED   38   18   8 
Received at Least 1 Dose of Study Drug   38   18   8 
COMPLETED   38   16   8 
NOT COMPLETED   0   2   0 
Investigator Decision                0                1                0 
Withdrawal by Subject                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Part A - 8 mg/m²/Day 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.
Part B - 5 mg/m²/Day 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.
Part B - 6 mg/m²/Day 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 Total of all reporting groups

Baseline Measures
   Part A - 8 mg/m²/Day   Part B - 5 mg/m²/Day   Part B - 6 mg/m²/Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   18   8   64 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.88  (6.3)   63.33  (8.4)   63.40  (9.1)   64.26  (7.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female   11   3   2   16 
Male   27   15   6   48 
Race/Ethnicity, Customized 
[Units: Participants]
       
Asian   12   5   4   21 
Black or African American   1   0   1   2 
White   25   13   3   41 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   17   10   4   31 
Romania   9   3   0   12 
South Korea   12   5   4   21 


  Outcome Measures

1.  Primary:   Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate)   [ Time Frame: Date of enrollment to date of measured progressive disease up to 99.6 weeks ]

2.  Primary:   Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)   [ Time Frame: Date of enrollment to date of measured progressive disease up to 18.1 weeks ]

3.  Secondary:   Part A: Progression-Free Survival   [ Time Frame: Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks ]

4.  Secondary:   Part B: Progression-Free Survival   [ Time Frame: Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeks ]

5.  Secondary:   Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)   [ Time Frame: Date of enrollment to date of measured progressive disease 99.6 weeks ]

6.  Secondary:   Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate)   [ Time Frame: Date of enrollment to date of measured progressive disease up to 18.1 weeks ]

7.  Secondary:   Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)   [ Time Frame: Days 1,5 and 9 of Cycle 1 (21-day cycle) ]

8.  Secondary:   Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355   [ Time Frame: Day 3 of Cycle 1 (21-day cycle) ]

9.  Secondary:   Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)]   [ Time Frame: Days 1,5 and 9 of Cycle 1 (21-day cycle) ]

10.  Secondary:   Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)]   [ Time Frame: Day 3 of Cycle 1 (21-day cycle) ]

11.  Secondary:   Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI)   [ Time Frame: Baseline and follow-up up to 104 weeks after the first dose of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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     History of Changes
Other Study ID Numbers: 12253
I1Y-MC-JFBD ( Other Identifier: Eli Lilly and Company )
First Submitted: December 1, 2009
First Posted: December 3, 2009
Results First Submitted: September 27, 2017
Results First Posted: December 4, 2017
Last Update Posted: December 4, 2017