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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

December 1, 2009
December 3, 2009
September 27, 2017
December 4, 2017
December 4, 2017
December 2009
July 2012   (Final data collection date for primary outcome measure)
  • 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 ]
    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) [ Time Frame: 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.
Overall response rate (response equals best response of complete response or partial response) [ Time Frame: Date of enrollment to date of measured progressive disease ]
Complete list of historical versions of study NCT01025284 on ClinicalTrials.gov Archive Site
  • 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 ]
    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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Days 1,5 and 9 of Cycle 1 (21-day cycle) ]
  • Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 [ Time Frame: 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-∞)] [ Time Frame: 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-∞)] [ Time Frame: Day 3 of Cycle 1 (21-day cycle) ]
  • 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 ]
    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).
  • Progression-free survival [ Time Frame: Date of enrollment to date of measured progressive disease or date of death from any cause ]
  • Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR]) [ Time Frame: Date of enrollment to date of measured progressive disease ]
  • Pharmacokinetics - Maximum Observed Drug Concentration [ Time Frame: Day 1,5,9 and 21 of cycle 1 ]
  • Pharmacokinetics - Area Under the Curve [ Time Frame: Day 1,5,9 and 21 cycle 1 ]
Not Provided
Not Provided
 
A Study for Participants With Small-Cell Lung Cancer
A Phase 2 Study of LY2523355 in Patients With Extensive-Stage Small-Cell Lung Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Small Cell Lung Cancer
  • Drug: LY2523355
    Administered intravenously as a 1-hour infusion
  • Drug: Granulocyte colony-stimulating factor (G-CSF)
    Administered subcutaneously
  • 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.
    Intervention: Drug: LY2523355
  • 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.
    Interventions:
    • Drug: LY2523355
    • Drug: Granulocyte colony-stimulating factor (G-CSF)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
50
July 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   Romania,   United States
 
 
NCT01025284
12253
I1Y-MC-JFBD ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP