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
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: LY2523355
Drug: Ixabepilone
Drug: pegfilgrastim
Drug: filgrastim
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of LY2523355 Versus Ixabepilone in Patients With Metastatic or Locally Recurrent Breast Cancer Who Have Received Prior Taxane Therapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Ixabepilone
Administered intravenously
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.
Drug: LY2523355
Administered intravenously
Drug: pegfilgrastim
Administered intravenously
Drug: filgrastim
Administered intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416389

Locations
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Myers, Florida, United States, 33916
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pensacola, Florida, United States, 32503
United States, Georgia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gainesville, Georgia, United States, 30501
United States, Maryland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bethesda, Maryland, United States, 20817
United States, Ohio
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cincinnati, Ohio, United States, 45219
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toledo, Ohio, United States, 43623
United States, South Carolina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Columbia, South Carolina, United States, 29210
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chattanooga, Tennessee, United States, 37404
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nashville, Tennessee, United States, 37203
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Worth, Texas, United States, 76104
United States, Virginia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01416389     History of Changes
Other Study ID Numbers: 12847, I1Y-MC-JFBE
Study First Received: August 11, 2011
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Locally
Recurrent
Breast
Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014