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A Study of LY2523355 in Participants With Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416389
First Posted: August 15, 2011
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
August 11, 2011
August 15, 2011
September 27, 2017
December 4, 2017
December 4, 2017
August 2011
August 2012   (Final data collection date for primary outcome measure)
Change in Tumor Size (CTS) From Baseline to the End of Cycle 2 [ Time Frame: Baseline up to end of Cycle 2 (Day 42) ]
The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment.
Change in Tumor Size (CTS) From Baseline to the End of Cycle 2 [ Time Frame: Baseline, end of cycle 2 ]
Complete list of historical versions of study NCT01416389 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Achieving an Overall Response (Overall Response Rate) [ Time Frame: Baseline to measured progressive disease or date of death from any cause (up to 423 days) ]
    Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.
  • Progression-free Survival (PFS) [ Time Frame: Baseline to measured progressive disease or date of death from any cause (up to 423 days) ]
    Progression-free survival (PFS) is the time from the date of randomization to the first date of progressive disease (PD) or death due to any cause, whichever occurs first. PD is as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines, and is defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 millimeter (mm) (the appearance of 1 or more new lesions was considered progression). Kaplan-Meier analysis was performed on the observed distribution of PFS. Participants were censored from analysis for the following reasons: lack of disease assessment, lost to follow-up, and further anticancer therapy started. Median PFS is presented.
  • Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate) [ Time Frame: Baseline to measured progressive disease or date of death from any cause (up to 423 days) ]

    Clinical benefit rate is the proportion of participants who achieve a best response of complete response (CR), partial response (PR), or stable disease (SD) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD is neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease, taking as reference the smallest sum diameter since treatment started.

    Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with measurable disease, multiplied by 100.

  • Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 [ Time Frame: Cycle 1: Day 1 and Day 3 ]
    Cmax is the maximum plasma concentration of LY2523355 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.
  • Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307 [ Time Frame: Cycle 1: Day 1 and Day 3 ]
    Cmax is the maximum plasma concentration of LSN2546307 (metabolite) after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.
  • Pharmacokinetics, Intracycle Accumulation Ration (Ra) of LY2523355 [ Time Frame: Cycle 1: Day 1 and Day 3 ]
    The intracycle accumulation ratio (Ra) is defined as the LY2523355 Cmax on Day 3 of Cycle 1 to the LY2523355 Cmax on Day 1 of Cycle 1 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.
  • Proportion of patients achieving an objective response (objective response rate) [ Time Frame: Baseline to measured progressive disease or date of death from any cause ]
  • Progression-free survival (PFS) [ Time Frame: Baseline to measured progressive disease or date of death from any cause ]
  • Proportion of patients achieving a clinical benefit (clinical benefit rate) [ Time Frame: Baseline to measured progressive disease or date of death from any cause ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Cycle 1: Day 1 and Day 3 ]
Percentage of Deaths on Study Through the Follow-up Period [ Time Frame: Baseline through end of treatment follow-up (up to 423 days) ]

The percentage of participants who died through the follow-up period of the study; the cause of death was not captured.

A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Not Provided
 
A Study of LY2523355 in Participants With Breast Cancer
A Randomized Phase 2 Study of LY2523355 Versus Ixabepilone in Patients With Metastatic or Locally Recurrent Breast Cancer Who Have Received Prior Taxane Therapy
The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: LY2523355
    Administered intravenously as a one hour infusion
  • Drug: ixabepilone
    Administered intravenously
  • Drug: pegfilgrastim
    Administered intravenously
  • Drug: filgrastim
    Administered intravenously
  • Experimental: LY2523355 + pegfilgrastim or filgrastim
    LY2523355: Five milligrams per meter squared per day (mg/m^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Pegfilgrastim or Filgrastim: Dosage is determined by standard of care and is administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
    Interventions:
    • Drug: LY2523355
    • Drug: pegfilgrastim
    • Drug: filgrastim
  • Active Comparator: ixabepilone
    Forty milligrams per meter squared per day (mg/m^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
    Intervention: Drug: ixabepilone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
September 2013
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have histologic or cytologic diagnosis of metastatic or locally recurrent breast cancer that is not amenable to therapy given with curative intent.
  • Have measurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 guidelines.
  • Have received 2 or more prior standard cytotoxic chemotherapy regimens for metastatic breast cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Regimens received in the neoadjuvant or adjuvant setting are not counted as prior regimens.
  • Have received a prior taxane in the neoadjuvant, adjuvant, or metastatic setting.
  • Have recovered from the acute effects of prior chemotherapy, hormonal therapy, and radiation prior to study enrollment.
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Have adequate organ function.

Exclusion Criteria:

  • Have Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater (moderate or worse) peripheral neuropathy
  • Have a second primary malignancy.
  • Have symptomatic, untreated, or uncontrolled central nervous system metastases.
  • Have received autologous stem cell transplant following high-dose chemotherapy.
  • Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study.
  • Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral hepatitis.
  • Have previously received LY2523355 in another study investigating this agent or therapy with ixabepilone or an ixabepilone-containing regimen.
  • Have a history of radiation therapy involving more than 25 percent of the bone marrow.
  • Have a Fridericia corrected QT (QTcF) interval of >470 milliseconds (msec) on screening electrocardiogram (ECG).
  • Have QRS widening of >120 msec on screening ECG.
  • Cannot change or stop taking a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or CYP3A4 inducer per the ixabepilone label.
  • Have hypersensitivity to drugs formulated with Cremophor® EL per the ixabepilone label.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01416389
12847
I1Y-MC-JFBE ( 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hour, 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