A Study for Patients With Small-Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01025284
First received: December 1, 2009
Last updated: January 11, 2013
Last verified: October 2012

December 1, 2009
January 11, 2013
December 2009
July 2012   (final data collection date for primary outcome measure)
  • Part A: Proportion of patients achieving an overall response (overall response rate) [ Time Frame: Date of enrollment to date of measured progressive disease ] [ Designated as safety issue: No ]
  • Part B: Proportion of patients achieving a best response (clinical benefit rate) [ Time Frame: Date of enrollment to date of measured progressive disease ] [ Designated as safety issue: No ]
Overall response rate (response equals best response of complete response or partial response) [ Time Frame: Date of enrollment to date of measured progressive disease ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01025284 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Date of enrollment to date of measured progressive disease or date of death from any cause ] [ Designated as safety issue: No ]
  • Part A: Proportion of patients achieving a best response (clinical benefit rate) [ Time Frame: Date of enrollment to date of measured progressive disease ] [ Designated as safety issue: No ]
  • Part B: Proportion of patients achieving an overall response (overall response rate) [ Time Frame: Date of enrollment to date of measured progressive disease ] [ Designated as safety issue: No ]
  • Part A: Pharmacokinetics - Maximum Observed Drug Concentration [ Time Frame: Day 1,5,9 and 21 of cycle 1 ] [ Designated as safety issue: No ]
  • Part B: Pharmacokinetics - Maximum Observed Drug Concentration [ Time Frame: Day 1,2,3,4 and 9 of cycle 1 ] [ Designated as safety issue: No ]
  • Part A: Pharmacokinetics - Area Under the Curve [ Time Frame: Day 1,5,9 and 21 of cycle 1 ] [ Designated as safety issue: No ]
  • Part B: Pharmacokinetics - Area Under the Curve [ Time Frame: Day 1,2,3,4 and 9 of cycle 1 ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Date of enrollment to date of measured progressive disease or date of death from any cause ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Maximum Observed Drug Concentration [ Time Frame: Day 1,5,9 and 21 of cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Area Under the Curve [ Time Frame: Day 1,5,9 and 21 cycle 1 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study for Patients 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 patients with extensive-disease in small-cell lung cancer.

Part B: This study evaluates an experimental treatment in patients with extensive-disease in small-cell lung cancer.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Small Cell Lung Cancer
Drug: LY2523355
Administered intravenously
  • Experimental: Part A LY2523355
    8 mg/m2 per dose based on patient's body surface area, administered intravenously on Days 1, 5, 9 of each 21-day cycle, until disease progression or unacceptable toxicity.
    Intervention: Drug: LY2523355
  • Experimental: Part B LY2523355
    5 mg/m2 per dose based on patient's body surface area, administered intravenously on Days 1, 2, 3 plus G-CSF support on each 21-day cycle, until disease progression or unacceptable toxicity.
    Intervention: Drug: LY2523355
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
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. Patients 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. Patients 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 patients without history of CNS metastases is not required
  • Part B: Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases or a history of CNS metastases. Patients who have received prophylactic radiation are not excluded. Screening of asymptomatic patients without history of CNS metastases is not required
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Korea, Republic of,   Romania
 
NCT01025284
12253, I1Y-MC-JFBD
No
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 2012

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