A Study of LY2523355 in Patients With Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01416389
First received: August 11, 2011
Last updated: January 7, 2014
Last verified: September 2013

August 11, 2011
January 7, 2014
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, end of cycle 2 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01416389 on ClinicalTrials.gov Archive Site
  • Proportion of patients achieving an objective response (objective response rate) [ Time Frame: Baseline to measured progressive disease or date of death from any cause ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Baseline to measured progressive disease or date of death from any cause ] [ Designated as safety issue: No ]
  • Proportion of patients achieving a clinical benefit (clinical benefit rate) [ Time Frame: Baseline to measured progressive disease or date of death from any cause ] [ Designated as safety issue: No ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Cycle 1: day 1 and day 3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of LY2523355 in Patients 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: LY2523355
    Administered intravenously
  • Drug: Ixabepilone
    Administered intravenously
  • Drug: pegfilgrastim
    Administered intravenously
  • Drug: filgrastim
    Administered intravenously
  • Active Comparator: Ixabepilone
    Dose determined by calculating participants body surface area, administered intravenously on Days 1 of a 21 day cycle for 2 Cycles. If at the end of 2 cycles the patient is receiving benefit, the patient may remain on study drug for additional cycles until a criterion for study discontinuation is met.
    Intervention: Drug: Ixabepilone
  • Experimental: LY2523355 + pegfilgrastim or filgrastim
    LY2523355: Dose determined by calculating participants body surface area, administered intravenously 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 patient is receiving benefit, the patient may remain on study drug for additional cycles until a criterion for study discontinuation is met.
    Interventions:
    • Drug: LY2523355
    • Drug: pegfilgrastim
    • Drug: filgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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 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% of the bone marrow.
  • Have QTcF interval of > 470msec 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01416389
12847, I1Y-MC-JFBE
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hour, EST) Eli Lilly and Company
Eli Lilly and Company
September 2013

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