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A Randomized Phase 2 Study of LY2523355 Versus Ixabepilone in Patients With Metastatic or Locally Recurrent Breast Cancer Who Have Received Prior Taxane Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Breast Cancer

Thank you

Trial Information

A Randomized Phase 2 Study of LY2523355 Versus Ixabepilone in Patients With Metastatic or Locally Recurrent Breast Cancer Who Have Received Prior Taxane Therapy


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in tumor size (CTS) from baseline to the end of Cycle 2

Outcome Time Frame:

Baseline, end of cycle 2

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

12847

NCT ID:

NCT01416389

Start Date:

August 2011

Completion Date:

June 2013

Related Keywords:

  • Metastatic Breast Cancer
  • Locally
  • Recurrent
  • Breast
  • Cancer
  • Breast Neoplasms

Name

Location

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.Jacksonville, Florida  32256
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.Athens, Georgia  30607
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  20817
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  45267
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.Greenville, South Carolina  29605
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.Memphis, Tennessee  38138
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.Bedford, Texas  76022
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.Norfolk, Virginia  23502