Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 1

NCT02057133

Breast Cancer

CDK4 & 6 Inhibitor


A Phase 1b Study of Abemaciclib in Combination With Therapies for Patients With Metastatic Breast Cancer*

NCT02057133
Key Inclusion Criteria
  • Parts A to E, G, and I: Hormone-receptor-positive (HR+), HER2-negative metastatic breast cancer (MBC)
  • Parts F and H: HER2-positive MBC
  • Parts A to F: Must have either measurable disease or nonmeasurable but evaluable bone disease
  • Parts G to I: Must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Parts H and I: Willing to undergo mandatory tumor biopsies prior to study treatment and at the time of discontinuation from study treatment
  • Females ≥18 years of age. For all parts except parts F and H: Must have either postmenopausal status or premenopausal status if continuing or beginning ovarian suppression with a luteinizing hormone-releasing hormone agonist
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Discontinuation of all previous therapies for breast cancer, except for ongoing corresponding combination therapy, for at least 21 or 14 days for myelosuppressive or nonmyelosuppressive agents, respectively, prior to receiving study drug(s) and recovery from the acute effects of therapy
  • Adequate organ function
  • Females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
  • Those with childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study drug
  • Life expectancy of ≥12 weeks
Key Exclusion Criteria
  • MBC with visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
  • Brain metastasis without prior radiotherapy (either whole-brain radiotherapy or stereotactic radiosurgery)
  • Intolerant of the standard therapy drug(s) administered in a specific part of the study
  • Received treatment within 14 days of the initial dose of study drug with an investigational product or nonapproved use of a drug or device (other than the study drug/device used in this study) for noncancer indications, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • History of presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
  • Serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (including interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, or history of major surgical resection involving the stomach or small bowel)
  • Central nervous system metastasis with either radiotherapy or development of neurological changes ≤14 days prior to receiving study treatment. Patients may be receiving a stable dose of corticosteroids
  • Active fungal, bacterial, or viral infection, including HIV or hepatitis
  • History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission with no therapy for a minimum of 3 years
 
*
This clinical trial is being conducted in the United States.
Additional criteria not shown here may exist for individual parts of the study.
Abemaciclib and LY3023414 are administered PO Q12H.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.