A Study of LY2523355 in Participants With Breast Cancer

NCT01416389 | Completed Phase 2 Results

• 2 other identifiers: 12847I1Y-MC-JFBE
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

Locally; Recurrent; Breast; Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Tumor Size (CTS) From Baseline to the End of Cycle 2

  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.

  Baseline up to end of Cycle 2 (Day 42)

Secondary Outcomes (6)

• Percentage of Participants Achieving an Overall Response (Overall Response Rate)

  Baseline to measured progressive disease or date of death from any cause (up to 423 days)

• Progression-free Survival (PFS)

  Baseline to measured progressive disease or date of death from any cause (up to 423 days)

• Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate)

  Baseline to measured progressive disease or date of death from any cause (up to 423 days)

• Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355

  Cycle 1: Day 1 and Day 3

• Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307

  Cycle 1: Day 1 and Day 3

Other Outcomes (1)

• Percentage of Deaths on Study Through the Follow-up Period

  Baseline through end of treatment follow-up (up to 423 days)

Study Arms (2)

LY2523355 + pegfilgrastim or filgrastim

EXPERIMENTAL

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.

Drug: LY2523355; Drug: pegfilgrastim; Drug: filgrastim

ixabepilone

ACTIVE COMPARATOR

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.

Drug: ixabepilone

Interventions

LY2523355 DRUG

Administered intravenously as a one hour infusion

LY2523355 + pegfilgrastim or filgrastim

ixabepilone DRUG

Administered intravenously

ixabepilone

pegfilgrastim DRUG

Administered intravenously

LY2523355 + pegfilgrastim or filgrastim

filgrastim DRUG

Administered intravenously

LY2523355 + pegfilgrastim or filgrastim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (12)

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, 33916, United States

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.

Pensacola, Florida, 32503, United States

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.

Gainesville, Georgia, 30501, United States

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.

Bethesda, Maryland, 20817, United States

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.

Cincinnati, Ohio, 45219, United States

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.

Toledo, Ohio, 43623, United States

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.

Columbia, South Carolina, 29210, United States

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.

Spartanburg, South Carolina, 29303, United States

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.

Chattanooga, Tennessee, 37404, United States

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.

Nashville, Tennessee, 37203, United States

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.

Fort Worth, Texas, 76104, United States

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.

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Recurrence; Neoplasms

Interventions

litronesib; ixabepilone; pegfilgrastim; Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 15, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2013
• Last Updated: September 18, 2019
• Results First Posted: December 4, 2017

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (12)